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NCT03456336 · ClinicalTrials.gov registry record · Phase 3
Management of the PDA Trial
A Phase 3 study of Infant, Premature and Infant, Newborn, Diseases, sponsored by NICHD Neonatal Research Network.
- Active
- Registry status
- Phase 3
- Development phase
- 836
- Enrollment target
- 19
- Study locations
NCT03456336: Active Phase 3 study of Infant, Premature and Infant, Newborn, Diseases, sponsored by NICHD Neonatal Research Network.
NCT03456336 is a Phase 3 study of Infant, Premature and Infant, Newborn, Diseases that is active but no longer recruiting, run by NICHD Neonatal Research Network. The registered enrollment target is 836 participants, below the 9,834-participant average among 16 other Infant, Premature trials with a reported enrollment target (91% lower). The trial reports 19 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03456336, a Phase 3 study of Infant, Premature and Infant, Newborn, Diseases, is active but no longer recruiting, sponsored by NICHD Neonatal Research Network.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 836 participants
- Enrollment target
- 19
- Study locations
Study Summary
Estimate the risks and benefits of active treatment versus expectant management of a symptomatic patent ductus arteriosus (sPDA) in premature infants.
Primary Outcome
A composite outcome for infants who were diagnosed with physiologic bronchopulmonary dysplasia (BPD) or died by 36 weeks postmenstrual age (PMA). Physiologic BPD is determined using existing Neonatal Research Network Generic Database criteria at 36 weeks PMA. Infants alive an in hospital are classified based on respiratory status at 36 weeks PMA or by a room air weaning challenge performed between 36 and 37 weeks PMA. Infants who are transferred or discharged before 36 weeks are classified based
Conditions Studied
Interventions
- OTHER Active Treatment
- OTHER Expectant Management
Study Locations (19)
Ohio
- Cincinnati Children's Medical Center - Cincinnati
- Case Western Reserve University, Rainbow Babies and Children's Hospital - Cleveland
- Research Institute at Nationwide Children's Hospital - Columbus
California
- Stanford University - Palo Alto
- Sharp Mary Birch Hospital for Women & Newborns - San Diego
North Carolina
- RTI International - Durham
- Duke University - Durham
Texas
- University of Texas Southwestern Medical Center at Dallas - Dallas
- University of Texas Health Science Center at Houston - Houston
Alabama
- University of Alabama at Birmingham - Birmingham
Georgia
- Emory University - Atlanta
Illinois
- Northwestern Lurie Children's Hospital of Chicago - Chicago
Iowa
- University of Iowa - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 836 participants |
| Start Date | 2019-02-22 |
| Est. Completion | 2027-05-30 |
| Phase | Phase 3 |
What the registry record for NCT03456336 still lists
NCT03456336 is an interventional study that assigns participants to a tested intervention. The registered 836 participants enrollment target is mid-sized for trials with a published cap, below the 9,834-participant average among 16 other Infant, Premature trials with a reported enrollment target (91% lower).
The record links to 4 conditions, with Infant, Premature appearing as the primary indexed condition, and to 2 interventions - of which Active Treatment is the first listed.
NCT03456336 lists 19 locations in 14 states (Ohio, California, North Carolina).
Frequently Asked Questions
What is clinical trial NCT03456336 about?
NCT03456336 is a clinical study titled "Management of the PDA Trial". Estimate the risks and benefits of active treatment versus expectant management of a symptomatic patent ductus arteriosus (sPDA) in premature infants.
What is the current status of trial NCT03456336?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 836 participants. The study started on 2019-02-22. Estimated completion is 2027-05-30.
What conditions does trial NCT03456336 study?
This clinical trial studies the following conditions: Infant, Premature, Infant, Newborn, Diseases, Patent Ductus Arteriosus, Patent Ductus Arteriosus After Premature Birth.
What interventions are being tested in trial NCT03456336?
The interventions under investigation include: Active Treatment (OTHER), Expectant Management (OTHER).
Who is sponsoring clinical trial NCT03456336?
This trial is sponsored by NICHD Neonatal Research Network, which has 61 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03456336 being conducted?
This trial has 19 study locations across Alabama, California, Georgia, Illinois, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Infant, Premature
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03456336's enrollment target sits among peer trials
836 8th of 16 higher than 9 of 16 other Infant, Premature trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Infant, Premature trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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Serial Assessment of Body Fat Accrual in Very Preterm Infants
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