Timing of PDA Closure and Respiratory Outcome in Premature Infants
Status:
Terminated
Trial end date:
2011-02-01
Target enrollment:
Participant gender:
Summary
The investigators propose the present study with the following aims:
- to determine whether early patent ductus arteriosus (PDA) treatment with ibuprofen
treatment at the onset of clinical symptoms is superior to late ibuprofen treatment only
when symptoms of a hemodynamically significant PDA are present in the evolution of
bronchopulmonary dysplasia (BPD) defined as duration of supplemental oxygen exposure
during the first 28 days
- to determine whether early PDA treatment with ibuprofen will be superior to late
treatment with ibuprofen in efficacy of PDA closure, need for rescue therapy, need for
PDA ligation and incidence of major complications of prematurity.
Hypothesis: Early pharmacologic closure of PDA with ibuprofen will improve respiratory course
and reduce BPD as reflected by a reduction in duration of supplemental oxygen during the
first 28 days of age vs. late pharmacologic treatment with ibuprofen.
Outcome variables: The primary outcome of this study is the number of days spent on
supplemental oxygen by each infant during the first 28 days.
Other outcomes to be determined between groups include:
- Mortality
- Other respiratory variables: total days on supplemental oxygen, days on mechanical
ventilation, oxygen dependence at 36 weeks post menstrual age, age at final extubation.
- Other respiratory complications: pneumothorax, pulmonary interstitial emphysema, need
for high frequency ventilation, pulmonary hypertension
- Efficacy of PDA closure: number of courses of medication required, need for ligation
- Other neonatal complications: intraventricular hemorrhage (IVH), periventricular
leukomalacia (PVL), retinopathy of prematurity (ROP), necrotizing enterocolitis (NEC),
intestinal perforation, sepsis, renal dysfunction (oliguria, elevated creatinine)
- Time to achieving full enteral feedings, time to regain birth weight, weight at
discharge.
- Length of hospital stay