3160—Late
Breakers: General Pediatrics; Medical Education and Dyslexia
Original
Science Abstracts - Platform Session
LB1
8:00am
Evening Continuity Clinic: A Solution to Resident Work
Hour Limitations?
Anda
Kuo, Christine Ma and Robert Kamei.
Department of Pediatrics, University of California San
Francisco, San Francisco, California.
Background:
The Accreditation Council for Graduate Medical
Education (ACGME) has recently passed limitations on
resident duty hours.
Complying with these regulations poses a
dilemma for residency programs where housestaff have
post-call, afternoon continuity clinics.
The post-call clinic violates the maximum
number of work hours and also may cause
sleep-deprivation and fatigue that affect resident
performance with their continuity patients.
Objective:
To evaluate housestaff experience with a
pilot program that replaced post-call continuity
clinics with evening continuity clinics.
Design/Methods:
In August 2002, we began a pilot of evening
continuity clinics at one continuity clinic site for
University of California San Francisco (UCSF)
pediatric residents.
Instead of post-call clinics, 19 residents had
evening continuity clinics added to a regular clinic
day when they were neither post-call nor on-call.
In January 2003, we surveyed housestaff
satisfaction and experience with the evening clinics,
particularly in comparison to post-call clinics.
Results:
Nineteen of 23 pediatric residents at the pilot
site participated in this pilot program.
Four residents who opted to continue their
post-call clinics had recently established an obesity
clinic. Nineteen
residents completed the survey (3 never had post-call
clinic and 4 never had evening clinic).
The percentage of residents who rated overall
satisfaction as good/outstanding was 80% for evening
clinic and 12.5% for post-call clinic (p <0.01).
All areas of patient care, medical education,
and clinic infrastructure were better or equal in
evening clinic in comparison to post-call clinic
except for continuity of preceptors and access to
medical services.
Actual patient show rate for the evening clinic
was not statistically different from regular afternoon
housestaff continuity clinic (62% versus 69%, p=0.24).
Conclusion:
Post-call afternoon continuity clinics violate
the recent ACGME policy on resident work hours.
Housestaff had greater satisfaction and a
better clinic experience with evening clinic versus
post-call clinic.
Evening housestaff continuity clinic is a
viable solution to meeting ACGME guidelines and may
provide better patient care and resident education
than post-call clinics.
|
LB2
8:15am
Maternal Depression and Infant Health Practices Among Low-Income Women
Esther K. Chung , Kelly F. McCollum, Irma
T. Elo, Helen J. Lee, Tina M. Riley, Margarita Rubio,
Jennifer F. Culhane.
Dept. of Pediatrics, A.I. duPont Hospital for Children/Thomas Jefferson
Medical College; Dept. of Obstetrics and Gynecology,
Thomas Jefferson Medical College; and the Dept. of
Sociology, Univ. of Pennsylvania, Philadelphia, PA.
BACKGROUND:
Maternal
depression affects 12 – 48% of mothers, with the
highest rates reported among low-income mothers.
Maternal depression is associated with inadequate
prenatal care and negative parenting behaviors.
OBJECTIVES: To determine the relationships between
maternal depression and maternal use of 1) infant
health services, 2) parenting practices, and 3) injury
prevention measures.
DESIGN/METHODS: Prospective, community-based survey.
774 mothers to date have been surveyed at 3
time-points pre- and post-partum.
Maternal depressive symptoms were determined by
the Center for Epidemiologic Studies Depression Scale
(CES-D) at each time-point. Use of infant health
services and preventative health practices were
measured. ANOVA and Chi-square analyses were performed
using STATA 6.0.
Multiple logistic regression analyses were
conducted, controlling for maternal
race/ethnicity, nativity, education, income, age,
employment status, parity, health, housing stability;
and infant birth weight, age, and health status.
RESULTS: The sample consisted of single (74%), uninsured (63%), young
(mean age: 23 + 6 yrs), low-income (mean income:
$8,063/year), African American (68%) mothers.
Forty-eight percent were depressed at one or two
points (sometimes) and 12% at all points (always).
When compared to mothers who were never
depressed, always depressed mothers were 2.5 times
(adjusted odds ratio [aOR] = 2.5; 95% confidence
interval [CI] = 1.4, 4.4) as likely to have their
child ever hospitalized, and 1.9 times (aOR = 1.9; 95%
CI = 1.1, 3.3) as likely to use corporal punishment.
Always depressed mothers were less likely to
have smoke detectors in their home (aOR = 0.3, 95% CI
= 0.1, 0.9) or use the back sleep position (aOR = 0.6;
95% CI = 0.3, 0.9) when compared to never depressed
mothers.
CONCLUSIONS: Maternal
depression persisting prepartum to postpartum is
associated with an increased risk of infant
hospitalization and use of corporal punishment; and a
lower likelihood of having a smoke detector or using
the back sleep position. Further efforts are needed to
reduce maternal depression, which may impact the
health and safety of young infants.
|
LB3
8:30am
Routine Use of Prevnar in a Pediatric Practice
Profoundly Alters the Microbiology of Acute Otitis
Media
Stan L. Block, James A. Hedrick, Christopher J.
Harrison.
Kentucky Pediatric Research, Bardstown, KY, and
Pediatric Infectious Disease, Univ. of Louisville,
Louisville, KY.
Background: Routine use of a new conjugated heptavalent
pneumococcal vaccine (PCV-7) in children < 2 years
could affect the microbiology and reduce overall
episodes of acute otitis media (AOM) in vaccinees. In
AOM, S.
pneumoniae (SP) has been the most common (40-45%)
pathogen recovered, and ~1/2 of strains were
non-susceptible to penicillin (PNSP).
Setting: Since Summer 2000, > 95% of children in this
7-clinician, sole pediatric practice in rural central
Kentucky had received at least 3 doses of PCV-7 by 7
m.o.
Objective: To determine changes in microbiology of AOM after
routine implementation of PCV-7.
Methods: Middle ear isolates from a convenience sample of
children with severe or refractory AOM were
prospectively identified, as our routine for the last
10 years. Among children 7-24 months, we compared 296
AOM isolates from 1992-98 with 81 AOM isolates from
Sept. 2000 to Feb. 2003.
Results: Children
were from all socio-economic classes and 95% white.
Comparing each time interval (92-98 vs. 00-03),
proportion of sources of isolates differed slightly:
tympanocentesis (85% vs. 75%), tympanostomy tube
otorrhea (7% vs. 15%) and spontaneous otorrhea (8% vs.
10%) (p=0.054). Rates of SP were 49% vs. 32%; non-typeable
H. influenzae
39% vs. 53% [beta-lactamase (+), 56% vs. 58%]; M.
catarrhalis 9% vs. 12%; and S.
pyogenes 3% vs. 2%. PCV-7 or PCV-7-related
serotypes comprised 77% (n=140) and 55% (n=22)
(p=0.033), of SP strains pre- and post- PCV-7,
respectively. Gram (-) bacteria accounted for 2/3 of
AOM isolates post-PCV-7 (p=0.26, O.R.=2.2)
Discussion:
Overall SP and PCV-7 serotypes in AOM were
significantly reduced by routine use of PCV-7 vaccine
in our practice. PNSP comprised 30% of AOM isolates in
92-98, whereas all SP comprised only 32% of AOM in
00-03. Gram (-) bacteria may become 2-fold more likely
than SP in de novo/refractory AOM in vaccinated young
children provided that: 1) high uptake of PCV-7 occurs
and 2) PCV-7 supply is adequate.
|
| LB4
8:45am
Development
of Left Occipito-Temporal
Systems for Skilled Reading Following a Phonologically
Based Intervention in Children
B.
A. Shaywitz, S. E. Shaywitz, B. Blachman, K. R. Pugh,
R. K. Fulbright, P. Skudlarski, W. E. Mencl, R. T.
Constable, J. M. Holahan, K. E. Marchione, J. M.
Fletcher, G. R. Lyon and J. C. Gore.
Reading
disability (developmental dyslexia) is one of the most
common neurobehavioral problems affecting children and
adults. There is now a strong consensus that the
central difficulty in dyslexia reflects a deficit
within the language system, and more particularly, in
a lower level component, phonology, which has to do
with the ability to access the underlying sound
structure of words.
In young school-age children a deficit in
phonology represents the most reliable and specific
correlate of dyslexia.
Such findings form the basis for the most
successful and evidence-based interventions designed
to improve reading.
According to recent findings, provision of an
evidence-based intervention at an early stage of
reading instruction leads to the development of fluent
reading (“the ability to read a text quickly,
accurately and with proper expression”), the
hallmark of skilled reading. Recent neurobiological
findings implicate left hemisphere posterior brain
systems in reading and, especially the left occipito-temporal
“word form” area, as critical in skilled reading
and that these posterior systems fail to function
properly in dyslexic children and adults. This dysfunction in left hemisphere posterior reading
circuits is already present in dyslexic children and
cannot be ascribed simply to a lifetime of poor
reading. Such evidence of a disruption in the normal
reading pathways provides a neurobiological target for
reading interventions.
We used functional magnetic resonance imaging
to study the effects of a phonologically based reading
intervention on brain organization and reading fluency
in 57 children ages 6.1-9.4 years; children comprised
three experimental groups: Experimental intervention
(n=37); community intervention (n=12) and community
controls (n=28).
Immediately after the year-long intervention,
children taught with the experimental intervention had
made significant gains in reading fluency and
demonstrated increased activation in left hemisphere
regions including the inferior frontal gyrus and the
middle temporal gyrus and one year after the
experimental intervention had ended these children
were activating bilateral inferior frontal gyri and
left superior temporal and occipito-temporal regions.
These data indicate
that teaching matters and that use of an
evidence-based reading intervention can facilitate the
development of those fast-paced neural systems that
underlie skilled reading.
|
LB5
9:00am
The Use of Dexamethasone in Mild Croup: A Multi-center
Randomized Controlled Trial
Candice
Bjornson, Terry P. Klassen, Janielee Williamson,
Rollin Brant, Amy Plint, Blake Bulloch, Lisa Evered,
Craig Mitton, and David W. Johnson.
Departments of Pediatrics, Faculties of Medicine,
Universities of Calgary, Alberta (Edmonton), Ottawa,
and Manitoba (Winnipeg), Canada.
BACKGROUND: The benefit of treating children with
moderate to severe croup with dexamethasone (DEX) is well established. However,
many children with croup have mild symptoms, and these
children may not derive the same degree of benefit
from treatment as those with more severe disease.
OBJECTIVES: To determine if the treatment of
children who present to an emergency department (ED) with mild croup with a single dose of oral DEX: 1) reduces the
rate of return to a health care provider for
persistent croup symptoms within 7 days of treatment,
and 2) reduces croup symptoms in the first 3 days
following treatment as measured by the Telephone
Out Patient (TOP) Score (a
validated tool for assessing croup severity).
DESIGN/METHODS: Children (3 mos.-9 yrs.) with
mild croup (Westley Croup Score < 2)
evaluated at 4 pediatric EDs
in 4 Canadian cities who met enrollment criteria and
whose parents gave written informed consent were
randomized to receive either a single oral dose of DEX
(0.6mg/kg) or placebo (PLAC).
All patients were initially discharged home and
their primary caretaker was contacted by telephone
1,2,3, 7, and 21 days later. To enhance the accuracy
of phone assessment, one trained study investigator
utilizing a standardized questionnaire incorporating
recordings of a barky cough and stridor conducted all
4 interviews with the same parent. Statistical methods
included Fisher’s exact test for the difference in
proportion of children per group returning for care by
day 7, and proportional odds model for ordinal
logistic regression for difference in the TOP
scores on days 1,2, and 3.
RESULTS: Between Sept 2000 & Feb 2003, 720
patients were enrolled (359 DEX).
26/352 (7.4%) &
53/352 (15.1%) of those patients treated with DEX
and PLAC,
respectively, returned to a health care provider
because of persistent symptoms (P=0.002, 95%CI for
Difference 3.0 - 12.3%).
Children treated with DEX
had significantly lower TOP
scores than those treated with PLAC
(P=0.001).
CONCLUSIONS: Children with mild croup treated
with a single oral dose of DEX, as compared with
placebo, had substantially fewer croup symptoms and,
as a result, markedly fewer return visits to a health
care provider in the week following treatment.
Funded by
Can. Institutes of Health Research
|
LB6
9:15am
Morbidity and Mortality Following RSV Associated
Hospitalization Among Premature Canadian Infants
John
Sampalis.
McGill University and JSS Medical Research Inc.
Montreal, Quebec, Canada
BACKGROUND/OBJECTIVES: Canadian guidelines
reserve RSV prophylaxis for infants born <33 weeks
GA with BPD. The
impact of RSV associated hospitalization on subsequent
use of hospital services and mortality in healthy
preterm infants born 32-35 weeks GA is assessed.
Pre-term infants are at increased risk for several
conditions some of which may be presentable including
RSV infections and hospitalizations.
The purpose of the current study was to assess
the impact of RSV infections on subsequent health care
resource utilization in pre-term infants.
METHODS: Case control study using Canadian
Institute of Health Information Discharge Abstract and
Morbidity databases. Cases are healthy infants, born
between 32-35 week gestation between 1998 and 2001 and
hospitalized for proven, or probable RSV. Controls
were matched to cases with respect to gestational age,
gender and province.
Infants with congenital abnormalities and BPD
were excluded. Mean
follow up was 1.66 years (Range: 1.4-3.0)
RESULTS: 2,415 cases of RSV associated
hospitalizations were identified and matched to 20,254
controls. The
mean (SD) age at the index admission was 0.65(0.44)
years and 46% of the total study sample was male.
Subsequent hospital services, excluding the
index event, for cases and controls respectively were:
Hospitalization: 2.96(2.81) vs. 1.28(1.42);
Special Care Unit Visits: 0.67(1.70) vs. 0.40(0.33);
Respiratory Therapy Visits: 0:31(0.70) vs. 0.13
(0.37); MD Consults: 3.61(4.54) vs. 0.89(1.12);
In-hospital Procedures: 1.05(4.02) vs. 0.81(1.51); Out
Patient Visits: 18.4(10.58) vs. 7.54(4.31); Total
inpatient days: 14.71(18.69) vs. 5.04(7.09).
All of these estimates were statistically
significantly higher for the cases (p=0.001).
Subsequent diagnoses for cases and controls
respectively were:
Respiratory conditions (64% vs. 13%); Fever
(2.7% vs. 0.7%); Anorexia (2.2% vs. 0.6%); Lack of
Normal Physiological Development (2.8% vs. 1.1%)
(P<0.05); The rate of sudden death was 6.1% in the
cases versus 0.3 % in the controls (p<0.05).
CONCLUSION: The results of this study
show that RSV hospitalization in healthy premature
infants is associated with a significant increase in
subsequent health care resource utilization and
mortality.
These results support prophylaxis of premature
infants against RSV hospitalization.
Funded by MedImmune, Inc.
|
LB7
9:30am
The Impact of Pulmonary Exacerbations on the Quality
of Life of Patients with Cystic Fibrosis
Michael
S. Yi, Joel Tsevat, Robert W. Wilmott, Uma R. Kotagal,
and Maria T. Britto. Dept. of Internal Medicine, Univ. of Cincinnati Med. Ctr., Dept. of
Pediatrics, Cincinnati Children’s Hospital Med.
Ctr., Cincinnati, OH, Dept. of Pediatrics, Cardinal
Glennon Children’s Hospital, St. Louis, MO.
BACKGROUND:
Pulmonary exacerbations (PE) have been shown to
negatively impact the health-related quality of life (HRQOL)
of patients with cystic fibrosis (CF), but little is
known about factors related to change in HRQOL after
PE. Our objective therefore was to investigate the
impact of PE on the HRQOL of patients with CF and to
elucidate factors that are associated with changes
post-PE.
METHODS:
Patients with CF completed the questionnaires at 3
points in time: 1) at baseline, 2) at the beginning of
the PE and 3) at follow-up after treatment. To measure
HRQOL, we used the Child Health Questionnaire-Parent
Form for patients < 18 years, and the SF-36 for
patients ≥ 18 years. We examined the following
predictor variables for association with change in
Physical Summary (PHS) and Psychosocial Summary (PSS)
HRQOL after PE: demographics, disease severity - % of
predicted forced expiratory volume in 1 second (FEV1), hospitalization, duration of antibiotic
therapy, mode of antibiotic therapy, duration of
nebulized therapy, presence or absence of pseudomonas
colonization, weight change, and time between PE and
follow-up. We used parametric and non-parametric
univariate statistical analyses, and linear regression
for multivariable analyses.
RESULTS: We
collected data from 52 PE in 48 subjects. Their mean
(SD) age at the time of PE was 15.8 (8.4) years; 27
(56.3%) were female; their mean (SD) baseline FEV1 was
60.5% (27.9%); their mean (SD) standardized PHS score
was 41.7 (12.9); their mean (SD) PSS score was 50.8
(9.3); and their mean (SD) time between the beginning
of the PE (time 2) and followup (time 3) was 2.7 (2.0)
months. In
univariate analyses, PE were associated with a
significant (p<0.05) decrease in FEV1 (-10.5%) and PHS scores (-3.9
points). PSS scores did not significantly change with
PE (-0.9 points). In multivariable analyses examining
change in PHS and PSS from the beginning
(time 2) of the PE to follow-up (time 3), no
variables were significantly associated with change in
PHS scores, but hospitalization was associated with
relative improvement in PSS scores. When examining
change from baseline (time 1) to follow-up (time 3),
greater duration
of antibiotic therapy and being hospitalized were
associated with relative worsening in PHS scores, and
hospitalization and being older were associated with
relative improvement in PSS scores.
CONCLUSION:
PE impact physical health more than psychosocial
health in children and adults with CF. Being
hospitalized was associated with relative improvement
in PSS scores following PE but with relative worsening
of PHS scores.
|
LB8
9:45am
Development of a Clinical Prediction Rule for
Diagnosis of Streptococcal Pharyngitis in Children in
Two Countries
Anne W. Rimoin, Hala Hamza, Adriana Vince,
Shammim Qazi, Mark C. Steinhoff.
Department
of International Health, Pediatrics, Johns Hopkins
Medical Institutions, Baltimore, MD; Cairo University,
Cairo, Egypt, University Infectious Disease Hospital,
Zagreb, Croatia WHO, Geneva, Switzerland.
Background: Many regions do not have laboratory facilities to
perform throat cultures for diagnosis of streptococcal
pharyngitis. We
therefore sought to develop a new clinical prediction
rule (CPR) for diagnosis of group A beta hemolytic
streptococcal (GABHS) pharyngitis without a
laboratory.
Objectives:
To develop a new CPR using patient history, signs and symptoms for
pediatric GABHS pharyngitis in two countries.
Design/Method: In
this prospective, descriptive study, we enrolled
children of ages 2 – 12 years in 2
pediatric outpatient clinics in Zagreb, Croatia and
Cairo, Egypt. (315 in Croatia, 997 in Egypt.)
Using a standard format we recorded demographic data,
history, signs and symptoms during physical
examination and rapid antigen test for diagnosis of
GABHS pharyngitis (Biostar Strep A OIA Max). Using
regression techniques, a CPR was developed for each
site to predict GABHS pharyngitis. Patient
characteristics, signs, symptoms, and rapid test
results were compared using appropriate statistical
tests. Sensitivity, specificity, and diagnostic odds
ratios (DOR) of the CPRs were compared.
Results: Using a rapid test, GABHS positivity differed between
sites: 40% vs. 25% (p= .000). A CPR using signs of
enlarged cervical lymph nodes or tonsillar enlargement
in children presenting to clinics with complaint of
cough, cold or sore/red throat had sensitivity
/specificity DOR of 88%/33%/ 3.4 in Croatia,
84%/25%/1.8 in Egypt; 85%/26%/ 2.1 combining both
populations.
Conclusion:
In these populations, the recommended WHO CPR
has a high specificity (90 – 93%) and DOR (2.9) but
low sensitivity (9 – 17.2%), hence does not treat up
to 91% of children who have GABHS pharyngitis. Our
modified CPR has a higher sensitivity (identifying
85-88% of GABHS cases) and adequate specificity and
has similar characteristics in two countries with
different populations.
This data indicates the need for prospective
studies of proposed treatment guidelines in varied
regions to characterize local performance in clinical
settings.
Funded by USAID.
|
3870—Neonatal
Clinical Studies
Original
Science Abstracts - Platform Session
LB-9
4:15pm
Is Prenatal Magnesium Sulfate Immediately Prior to Very
Preterm Birth Neuroprotective for Babies?
The ACTOMgSO4 Trial: A Randomized
Placebo-Controlled Trial
Caroline A Crowther, Janet E Hiller, Lex W Doyle, Ross
R Haslam, for the ACTOMgSO4 (Australasian Collaborative Trial
of Magnesium Sulphate) Collaborative Group. University of
Adelaide, Adelaide, Women’s and Children’s Hospital,
Adelaide, The University of Melbourne and The Royal Women’s
Hospital, Melbourne, Australia.
Background:
Infants born very preterm have a high risk of dying in
the newborn period or of surviving with cerebral palsy.
Magnesium sulfate given to women immediately prior to
preterm birth may reduce these risks.
Objective:
To
assess if prenatal magnesium sulfate was neuroprotective for
the very preterm fetus.
Methods: Consenting women with a pregnancy <30 weeks’ gestational
age where birth was planned or expected within 24 hours were
randomized at 16 centers in Australia and New Zealand to
either intravenous magnesium sulfate (loading dose 4 g over 20
minutes, then 1g per hour for up to 24 hours; n = 535) or an
equal volume of normal saline placebo (n = 527).
Primary outcomes in children at two years’ corrected
age were total mortality and cerebral palsy.
Results: Side effects were reported in 89% of women given magnesium
sulfate versus 38% of women given placebo; however, no women
had serious side effects of therapy.
Total mortality (13.8% vs 17.1%; adjusted relative risk
[RR] 0.83, 95% CI 0.64-1.09), cerebral palsy in survivors
(6.8% vs 8.2%; RR 0.83, 95% CI 0.54-1.27) and combined death
or cerebral palsy (19.8% vs 24.0%; RR 0.83, 95% CI 0.66-1.03)
were less frequent for babies exposed to magnesium sulfate,
but none of the differences were statistically significant.
Significantly fewer survivors exposed to magnesium
sulfate had substantial motor dysfunction at 2 years of age
(3.4% vs 6.6%; RR 0.51, 95% CI 0.29, 0.91).
Conclusions: The potential clinically important improvement in pediatric
outcomes from magnesium sulfate given to women immediately
prior to very preterm birth urgently needs confirmation in
further trials. There
do not appear to be serious harmful effects for the women or
their children.
Funded, in part, by a grant from the
National Health and Medical Research Council, Australia.
LB-10
4:30pm
Cesarean Rates and Neonatal Morbidity in a Low Risk Population
Jeffrey
Gould, Beate Danielson, Lisa Korst, Roderic Phibbs, Kathy
Chance, Elliot Main, David Wirtschafter, David Stevenson for
the California Perinatal Quality Care Collaborative ( CPQCC)
BACKGROUND: The
dramatic increase in cesarean section, and the demonstration
that operative deliveries may not always be medically
indicated, has led to a national effort to reduce cesarean
births. It is generally assumed that lower cesarean rates are
indicative of high quality obstetric care.
OBJECTIVE: To test this assumption in a statewide,
low risk cohort
METHODS: Vital records
and administrative discharge data for 748,604 California
singleton live births without congenital abnormalities born
1998-2000 were used. 282
institutions were classified Average (160), Low (62) and High
(60) cesarean (CS) hospitals on the basis of their cesarean
rate in a low risk cohort of mothers without a previous
cesarean, in labor at term, with no evidence of maternal,
fetal, or placental complications. Neonatal outcomes and
interventions determined by ICD-9-CM codes were compared
across the three groups of hospitals.
RESULTS:
Compared to Average CS hospitals, low risk infants born at Low
CS hospitals had a higher incidence of morbidity and
intervention suggesting that some infants might have benefited
from cesarean delivery. Infants delivered at High CS rate
hospitals also had increased morbidity and intervention
suggesting that high cesarean rates in themselves are not
protective.
|
|
Low
CS (3.5%)
|
Average
CS (5.7%)
|
High
CS (8.3%)
|
|
|
Birth
Trauma
|
20.7
|
20.5
|
23.4*
|
|
|
Birth
Asphyxia
|
.93*
|
0.72
|
1.11*
|
|
|
Meconium
aspiration
|
24.8*
|
21.7
|
20.2
|
|
|
Feeding
problems
|
12.4*
|
9.34
|
9.57
|
|
|
Infection
|
14.6*
|
13.9
|
14
|
*=
|
|
IV/IM
Medication
|
5.74*
|
3.43
|
2.53
|
P<.01
|
|
Mechanical
Ventilation
|
17.2*
|
11.7
|
14.2*
|
vs.
|
|
Transfusion
for shock
|
1.16*
|
0.96
|
0.91
|
Average
|
CONCLUSION:
Assessing the quality of obstetrical care will require
strategies that go beyond the measurement of cesarean rates
and include the evaluation of neonatal outcomes.
LB-11
4:45pm
Randomized Pilot Trial of Delivery Room CPAP in the ELBW
Infant
N. Finer, W. Carlo, S. Duara, A. Fanaroff, E. Donovan, for the NICHD
Neonatal Network.
Background:
Prior studies
suggest that early continuous airway positive pressure (CPAP)
may be a beneficial form of ventilatory support for the ELBW
infant by avoiding intubation, and subsequent chronic lung
disease, and no prospective studies have evaluated the
feasibility of this approach.
Objective:
To prospectively
evaluate the delivery room (DR) resuscitation and need for
intubation of ELBW infants who were randomized to CPAP/PEEP or
no CPAP/PEEP during resuscitation while avoiding delivery room
intubation for surfactant administration.
Design/Methods:
ELBW infants < 28
weeks gestation, born in 5 NICHD Network NICUs from July 2002
to January 2003 were randomized to receive either CPAP/PEEP or
not using a t-piece resuscitator (Neopuff®). No
infant was to be intubated for the sole purpose of surfactant
administration in the delivery room. Following NICU admission
all non-intubated infants were placed on CPAP and were
intubated for surfactant administration only after meeting
specific criteria: an FiO2 > .3 with an SaO2 < 90%
and/or a PaO2 < 45 torr, a PaCO2 > 55 torr, or apnea
requiring bag and mask ventilation.
Results:
Enrollment was 103 infants, 55 CPAP and 48 Control infants.
Video recording of the resuscitation was performed for 71
infants. No infant was intubated in the DR only for
surfactant. Intubation for resuscitation occurred in 27 of 55
CPAP infants and 19 of 48 control infants (p=.333). All
infants of 23 weeks gestation required intubation for
resuscitation in the delivery room, irrespective of treatment
group, whereas only 4 of 22 (18%) infants of 27 weeks or
greater required intubation. CPAP infants required a mean of
1.58 intubation attempts in the DR compared with 1.89 attempts
for Control infants (p=.62) and the mean and median duration
of the first intubation attempt was 35.8, and 30 seconds and
33 and 35 seconds for the CPAP and Control infants (p=.694).
For infants not intubated in the DR, 36 infants were
subsequently intubated in the NICU by day 7, 16 CPAP infants
and 20 Control infants, (p=.207), with 80% of infants
intubated by day 7.
Conclusions:
Approximately 50% of infants less than 28 weeks gestation
require intubation for resuscitation in the DR, unaffected by
the use of DR CPAP/PEEP, and 80% are intubated by day 7. Early
CPAP alone for ventilatory support is unlikely to be a
successful intervention in such infants and these observations
facilitate the appropriate planning of future studies.
LB-12
5:00pm
Early Surfactant Replacement in Spontaneously Breathing
Premature Infants with RDS
Roger
F. Soll, Jeanette M. Conner, Diantha Howard and the
Investigators of the Early Surfactant Replacement Study. U of Vermont, Burlington, VT, Vermont Oxford
Network, Burlington, VT.
Background:
Spontaneously breathing premature infants with respiratory
distress syndrome (RDS) may benefit from early surfactant
treatment.
Objective:
To evaluate the effect of intubation and early surfactant
administration in spontaneously breathing premature infants
with signs and symptoms of RDS.
Design:
Multicenter RCT conducted at NICUs in the Vermont Oxford
Network. Spontaneously breathing infants with birth weight
1501-2500 g were eligible for enrollment if they had
respiratory distress requiring ł
30% supplemental oxygen, a PCO2 < 65 mmHg, and a CXR
compatible with RDS. Infants between 2 and 24 hours of age
were randomly assigned to early intubation, surfactant
treatment, and rapid extubation [ER Group] or standard
respiratory management, including possible intubation and
surfactant treatment based on clinical indications [SM Group].
The primary outcome measure was defined as the need for
mechanical ventilation in the first week of life.
Results:
267 infants were randomized and enrolled at 33 participating
centers. Infants in the ER Group (N=137) were comparable to
those in the SM Group (N=130) regarding birth weight,
gestational age, race, prenatal care, and need for initial
respiratory support. Fewer infants randomized to the ER Group
required mechanical ventilation during the first week of life
[38% vs. 48%, p=0.07, Relative Risk (RR) 0.78, 95%CI 0.59,
1.03]. Infants in the ER Group received more surfactant doses
than infants in the SM Group (1.3+/-0.7 vs. 0.8+/-1.1, p <
0.001). Pneumothorax occurred in 6% of the ER Group vs. 10% in
the SM Group (RR 0.58, 95%CI 0.25, 1.35). There were no
differences between the groups in pulmonary hemorrhage, patent
ductus arteriosus, bacterial sepsis, intraventricular
hemorrhage, and necrotizing enterocolitis.
Conclusion:
Spontaneously breathing infants treated with early intubation,
surfactant replacement, and rapid extubation appear to require
less mechanical ventilation during the first week of life than
infants who received standard respiratory care. Additionally,
there was a trend towards a decreased rate of pneumothorax in
infants in the early treatment group, a finding noted in
previous studies of this treatment approach. (Partially funded
by a grant from Ross Laboratories).
LB-13
5:15pm
Is Surfactant Therapy Beneficial in the Management of the Term
Neonate with Congenital Diaphragmatic Hernia?
JoDee M.
Anderson, and The Congenital Diaphragmatic Hernia Study Group.
Department of Pediatrics, Stanford University, Stanford,
California
BACKGROUND: Congenital diaphragmatic hernia (CDH) continues to
be associated with significant morbidity and mortality.
Numerous therapeutic modalities have been employed over
the last decade to treat patients with CDH, however the
efficacy of many of these interventions has not yet been
determined. Previous
studies have suggested that surfactant deficiency may play a
role in the pulmonary pathology of CDH.
The purpose of this analysis was to determine the
benefit of surfactant on term infants with CDH.
OBJECTIVE: To evaluate the association of surfactant
administration with survival, the need for ECMO and oxygen use
at 30 days of life (CLD) in term infants with CDH.
METHODS:
The present study utilized data from the 2,285 live born
infants enrolled in the multi-center CDH Study Group Registry
between 1995 and 2001. Infants
> 37 weeks gestation with immediate distress at
delivery were included in the analysis; those with major
congenital anomalies were excluded.
For univariate analysis, chi-square tests were used for
categorical variables and unpaired t-tests were used for
nominal variables. Factors
identified as significant in univariate analysis were used in
multiple regression analysis. Significance
was defined as p<0.05.
RESULTS: 1075 patients were included in the analysis,
300 of which were treated with surfactant. Comparison of demographic and perinatal variables revealed
that infants in the surfactant-treated group were of lower
gestational age (38.8+1.1 vs. 39.1+1.3 weeks, p=0.012), more
likely to be prenatally diagnosed (62% vs. 43%, p<0.0001),
inborn (44% vs. 36%, p=0.016), and to have received CPR in the
delivery room (21% vs. 16%, p=0.42).
Infants in the surfactant-treated group were also more
likely to have been treated with vasopressors (93% vs. 77%,
p<0.0001) and inhaled nitric oxide (61% vs. 35%,
p<0.0001). Regression
analysis for surfactant use with demographic, perinatal and
treatment variables showed that prenatal diagnosis,
vasopressor use and iNO were significant independent risk
factors. A
separate analysis of prenatally diagnosed patients alone
revealed that surfactant use was associated with significantly
lower survival (57.3% vs, 70.3%, p=0.008).
Among all infants, surfactant use was associated with
significantly lower survival (61% vs. 73%, p=0.001), increased
need for ECMO (62% vs. 45%, p<0.0001), and increased
incidence of CLD (68% vs. 38%, p<0.0001).
CONCLUSION: In term neonates with CDH, surfactant use is
associated with lower survival, increased ECMO use and
increased incidence of CLD. Surfactant use does not appear to provide any benefit for the
term infant with CDH.
LB-14
5:30pm
Combined Inhibition of Nitric Oxide (NO) and Prostaglandin
(PG) Synthesis for Refractory Patent Ductus Arteriosus (PDA)
R.
L. Keller, T. A. Tacy, R. I. Clyman.
Dept of Pediatrics,
University of California San Francisco, CA.
Background: Studies
in premature animals suggest that 1) prolonged, complete
closure of the ductus lumen is necessary to produce permanent
anatomic closure; and 2) ductal NO production augments the
effect of PGs on ductus patency. In premature newborns (<28
wks), a recurrent hemodynamically significant PDA frequently
occurs after indomethacin (INDO) therapy if Doppler evidence
of ductus patency is seen after the initial 3 INDO doses. We
hypothesized that combination therapy with INDO and an NO
synthase inhibitor (L-NMMA) would produce a tighter degree of
ductus constriction than additional doses of INDO alone and
would result in permanent closure if this degree of
constriction could be maintained for >48 h.
Methods: From
1/99-2/03, 43 infants (<28 wks) who survived >1 wk had
persistent Doppler ductal patency after receiving 3 doses of
prophylactic INDO (0.2, 0.1, 0.1mg/kg). 11/43 newborns with
persistent ductal flow after 3 INDO doses received a
continuous L-NMMA infusion (in a Phase I/II trial designed to
last 72 h) plus additional INDO therapy (0.1 mg/kg Q 24 hr x
3). 32/43 infants received additional INDO alone because L-NMMA was not
available or the parents declined the study. These
infants served as a comparison group.
Results: L-NMMA
doses of 10-20 mg/kg/h raised serum creatinine and systemic
blood pressure. Both conditions resolved with discontinued
therapy or decreased dose. At 5 mg/kg/hr serum creatinine was
stable but hypertension limited L-NMMA infusion rates. 91% (10/11) of the INDO+L-NMMA group had complete
ductal constriction with no ductal flow seen on Doppler. Only
1/6 (17%) of the infants who received INDO+L-NMMA for >60 h
(mean 70 + 4 h) developed a symptomatic PDA requiring
surgical ligation. In contrast, all of the 5 infants who had <48
h (mean 35 + 9 h) of INDO+L-NMMA required PDA ligation.
Only 47% (15/32) of the comparison group closed their ductus
by Doppler; 68% (22/32) ultimately required surgical PDA
ligation.
Conclusion:
In this Phase I/II trial, INDO+L-NMMA produced tighter ductus
constriction than INDO alone (P<.05). Combined
therapy for >60 h had a higher permanent closure rate than
a shortened course (P<.05) or INDO alone (P<.05).
No significant differences in long-term adverse outcomes were
seen.
LB-15
5:45pm
High-Dose Anti-D Immune Globulin Raises the Platelet Count in
Newly Diagnosed Childhood ITP More Rapidly Than Standard-Dose
Anti-D and Higher Than IVIg
Michael Tarantino, Guy Young, Salvatore Bertolone,
Karen Kalinyak, Frank Shafer, Roshni Kulkarni, Lisa Weber,
Diane Nugent for the Pediatric ITP Study Group. Comp. Bleeding Disorders
Center, Peoria, IL, Children’s Hosp of Orange County,
Orange, CA, U of Louisville, Louisville, KY, Children’s Hosp
Medical Center, Cincinnati, OH; St. Christopher’s Hosp,
Philadelphia, PA; Michigan State U, East Lansing, MI
Although
the treatment of childhood ITP is controversial, a majority of
pediatric hematologists treat newly diagnosed severe ITP with
immune globulin. We conducted a multi-center, randomized
prospective trial of immune globulin treatment as the initial
therapy for 105 newly diagnosed ITP in Rh+ children, aged 1-18
years that presented with a platelet count < 20,000/µL.
Subjects received either 1) single dose 50µg/kg anti-D, IV
over 5-10 minutes, 2) single dose 75 µg/kg anti-D IV over
5-10 minutes, or 3) single dose 0.8g/kg, IVIg (brand not
restricted), IV over 4-6 hours. Hematological parameters were
monitored daily until the platelet count exceeded 50,000/µL,
then weekly-to-monthly for six months. Adverse events were
followed prospectively. Preliminary results are reported
below.
|
Study arm
|
N
|
M:F
|
Age (yrs), mean, median, range
|
Platelet count (x 103/µL)
Initial
24 hrs
7 days
|
%response (plt>20K)
|
|
Anti-D 50µg/kg
|
35
|
0.8:1
|
4.9, 4, 1-16
|
8.5±5.4
|
33±28
|
177±127
|
78 at 72hrs
|
|
Anti-D 75µg/kg
|
35
|
0.8:1
|
4.6, 4, 1-15
|
9.5±4.7
|
47±37
|
288±219*
|
81 at 72hrs
|
|
IVIg 0.8 g/kg
|
35
|
0.9:1
|
5.8, 4, 1-17
|
8.9±5.2
|
46±32
|
198±186
|
81 at 72hrs
|
*
p=0.03, <0.005 for anti-D 75µg/kg v. IVIg 0.8g/kg and v.
anti-D 50µg/kg, respectively.
Wet purpura (any of: mucosal hemorrhage, hemoptysis,
melana, hematuria) was reported in 27% of subjects at study
entry. By day 7 hemoglobin concentrations decreased by 1.5, 2
and 0.3 g/dL in arm 1, 2 and 3, respectively. No serious
adverse events related to either drug were reported. One
subject, presenting with dry purpura, was refractory to
treatment and had an intracranial hemorrhage 3 months into the
study. Adverse events were otherwise mild. In summary, Anti-D,
75µg/kg raised the platelet count in newly diagnosed
childhood ITP more rapidly than standard-dose anti-D and
significantly higher than single dose IVIg. Additional
monitoring (ie chronicity, number of treatments) is ongoing.
This study was funded, in part, by Nabi. Nabi did not
participate in study execution or data analysis.
LB-16
6:00pm
International Formula-Based Nutritional Intervention for
Infants Born to HIV-Infected Women
Ross E. McKinney, Maria Leticia S. Cruz, Christine
Powell, Michael Hughes, James M. Oleske, Harland Winter, Carol
Elgie, Lynette Purdue, David Wolf, Shiara Ortiz-Pujols, Nancy
|