Timing of PDA Closure and Respiratory Outcome in Premature Infants
Information source: University of Miami
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Patent Ductus Arteriosus
Intervention: ibuprofen (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University of Miami
Summary
The investigators propose the present study with the following aims:
- to determine whether early PDA treatment with ibuprofen (specifically treatment at the
onset of clinical symptoms) is superior to late ibuprofen treatment (specifically
treatment only when symptoms of a hemodynamically significant PDA are present) in the
evolution of BPD (defined as duration of supplemental oxygen exposure during the first
28 days), and
- 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: IVH, PVL, ROP, 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
Clinical Details
Official title: Timing of PDA Closure and Respiratory Outcome in Premature Infants
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: The primary outcome of this study is the number of days spent on supplemental oxygen by each infant during the first 28 days.
Secondary outcome: Mortality; d on O2, d on ventilation, O2 dependence/36 wk PMA, age at extubation; pneumothorax, PIE, HFOV, pul hypertension; efficacy of PDA closure: # courses of medication, PDA ligation; IVH, PVL, ROP, NEC, intestinal perf, sepsis, renal dysfunction
Eligibility
Minimum age: N/A.
Maximum age: 14 Days.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Inborn patients at JHS hospitals (admitted to the NICU at JMH within the first 72 hrs
of age
- BW 500-1250 grams
- 23-32 wks gestational age
- > 1d but < 14d of age.
Exclusion Criteria:
- Major congenital malformations
- Proven sepsis (positive blood culture)
- Contraindications to the use of Ibuprofen or Indomethacin
- Terminal condition, not expected to survive beyond 48 h
- Infants born excessively SGA(3 S. D. below the mean for GA)
- Infants with initial PDA presentation that is hemodynamically significant
Locations and Contacts
Jackson Memorial Hospital/Holtz Children's Center, Miami, Florida 33136, United States; Recruiting
Ilene RS Sosenko, MD, Phone: 305-585-6408, Email: isosenko@miami.edu
Eduardo Bancalari, MD, Phone: 305-585-6408, Email: ebancalari@miami.edu
Ilene RS Sosenko, MD, Principal Investigator
Additional Information
Starting date: November 2007
Ending date: December 2010
Last updated: December 4, 2008
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