Clinical trial NCT00802685: Timing of PDA Closure and Respiratory Outcome in Premature Infants
Official title: Timing of PDA Closure and Respiratory Outcome in Premature Infants
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Patent Ductus Arteriosus
Keywords: Patent ductus arteriosus
Respiratory outcome
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: H. Lundbeck A/S
First posted: 2008-12-05
Enrollment: 105
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed description: Study terminated when intravenous (IV) ibuprofen withdrawn for both clinical and research use.

Eligibility 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

Primary outcomes:
measure: Days Spent on Supplemental Oxygen During the First 28 Days.
timeFrame: 28 days of life
Secondary outcomes:
measure: Number of Participants on Oxygen at 36 Weeks Postmenstrual Age
timeFrame: at 36 weeks postmenstrual age
Other outcomes:
Locations:
city: Miami
country: United States
facility: Jackson Memorial Hospital/Holtz Children's Center
state: Florida
Study officials:
affiliation: University of Miami
name: Ilene RS Sosenko, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sosenko IR, Fajardo MF, Claure N, Bancalari E. Timing of patent ductus arteriosus treatment and respiratory outcome in premature infants: a double-blind randomized controlled trial. J Pediatr. 2012 Jun;160(6):929-35.e1. doi: 10.1016/j.jpeds.2011.12.031. Epub 2012 Jan 28.