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NCT00802685 · ClinicalTrials.gov registry record · NA
Timing of PDA Closure and Respiratory Outcome in Premature Infants
A NA study, sponsored by University of Miami.
- Terminated
- Registry status
- NA
- Development phase
- 105
- Enrollment target
NCT00802685 is a NA study that was terminated before completion, run by University of Miami. The registered enrollment target is 105 participants.
The verdict
NCT00802685, a NA study, was terminated before completion, sponsored by University of Miami.
- TERMINATED
- Registry status
- NA
- Development phase
- 105 participants
- Enrollment target
Study 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
Interventions
- DRUG Early ibuprofen
- OTHER Late ibuprofen expectant group (placebo)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2007-11 |
| Est. Completion | 2011-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00802685
The ClinicalTrials.gov registry entry for NCT00802685 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 105 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Miami, which has 721 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Early ibuprofen is the first listed.
NCT00802685 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00802685 about?
NCT00802685 is a clinical study titled "Timing of PDA Closure and Respiratory Outcome in Premature Infants". 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 p...
What is the current status of trial NCT00802685?
This trial is currently terminated. It is a NA study. The enrollment target is 105 participants. The study started on 2007-11. Estimated completion is 2011-02.
What interventions are being tested in trial NCT00802685?
The interventions under investigation include: Early ibuprofen (DRUG), Late ibuprofen expectant group (placebo) (OTHER).
Who is sponsoring clinical trial NCT00802685?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
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