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Clinical Trials in Mexico / NCT03456336
Active, not recruiting Phase 3

Management of the PDA Trial

NCT03456336 · tracked via the Priya Life Science Mexico tracker
Sponsor
NICHD Neonatal Research Network
Phase
Phase 3
Started
2019-02-22
Last updated
2026-05-12

Condition(s) studied

Infant, PrematurePatent Ductus ArteriosusInfant, Newborn, DiseasesPatent Ductus Arteriosus After Premature Birth

Investigational drug(s) / intervention(s)

Active TreatmentExpectant Management

Active Treatment: Infants assigned to the active treatment group will receive indomethacin or ibuprofen per their local site usual care dosing and schedule if the infant has a sPDA. The choice of indomethacin or ibuprofen will be left to the center, however, infants may only receive one or the other. If the infant receives both, it will be considered a protocol violation.

Expectant Management: Infants assigned to the expectant management group will receive indomethacin or ibuprofen if cardiopulmonary compromise occurs.

Study summary

Estimate the risks and benefits of active treatment versus expectant management of a symptomatic patent ductus arteriosus (sPDA) in premature infants.

Eligibility

Sex
ALL
Min age
48 Hours
Max age
21 Days
Healthy volunteers
No
Inclusion Criteria: * Postnatal age 48 hours -21 days * Infant 22 0/7 to 28 6/7 weeks gestation at birth * sPDA, as defined as: 1. Mild, Moderate, or Severe Clinical Criteria with Small or Moderate size PDA on echocardiogram 2. Mild or Moderate Clinical Criteria with Large PDA on echocardiogram Exclusion Criteria: * Cardiopulmonary compromise * Known congenital heart disease (besides atrial septal defect or ventricular septal defect) * Known pulmonary malformation (e.g. congenital lobar emphysema, congenital pulmonary adenomatous malformation) * Any condition which, in the opinion of the investigator, would preclude enrollment

Primary outcome measure(s)

  • Death or Bronchopulmonary Dysplasia (BPD) at 36 Weeks PMA — Randomization to 36 weeks PMA
    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 on the support they are receiving at that time. Infants who died before 36 weeks PMA are not assessed for BPD. Deaths include all-cause deaths between randomization and 36 weeks PMA.

Trial sites (19)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama
Stanford University Palo Alto California
Sharp Mary Birch Hospital for Women & Newborns San Diego California
Emory University Atlanta Georgia
Northwestern Lurie Children's Hospital of Chicago Chicago Illinois
University of Iowa Iowa City Iowa
University of Mississippi Medical Center - Children's of Mississippi Jackson Mississippi
University of New Mexico Albuquerque New Mexico
University of Rochester Rochester New York
RTI International Durham North Carolina
Duke University Durham North Carolina
Cincinnati Children's Medical Center Cincinnati Ohio
Case Western Reserve University, Rainbow Babies and Children's Hospital Cleveland Ohio
Research Institute at Nationwide Children's Hospital Columbus Ohio
University of Pennsylvania Philadelphia Pennsylvania
Brown University - Women and Infants Hospital of Rhode Island Providence Rhode Island
University of Texas Southwestern Medical Center at Dallas Dallas Texas
University of Texas Health Science Center at Houston Houston Texas
University of Utah Salt Lake City Utah

More NICHD Neonatal Research Network trials in Mexico

Milrinone for Prevention of Post-ligation Cardiac Syndrome Trial Recruiting
Neonatal Platelet Transfusion Threshold Trial Recruiting
Follow-up Visit of High Risk Infants Recruiting
Continued Pressure for Alveolar Protection (CPAP Trial) Recruiting
The Budesonide in Babies (BiB) Trial Active, not recruiting

Other trials for the same condition

Neonatal Platelet Transfusion Threshold Trial Recruiting
Follow-up Visit of High Risk Infants Recruiting
Generic Database of Very Low Birth Weight Infants Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03456336 on ClinicalTrials.gov ↗ ← All trials in Mexico