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Active Treatment vs Expectant Management for Patent Ductus Arteriosus (PDA Trial)

Phase 3

Recruiting

Research Sponsored by NICHD Neonatal Research Network

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Postnatal age 48 hours -21 days

sPDA, as defined as: Mild, Moderate, or Severe Clinical Criteria with Small or Moderate size PDA on echocardiogram

Must not have

Known pulmonary malformation (e.g. congenital lobar emphysema, congenital pulmonary adenomatous malformation)

Known congenital heart disease (besides atrial septal defect or ventricular septal defect)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 26 months corrected age

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial compares the effects of active treatment versus expectant management for a symptomatic patent ductus arteriosus (sPDA) in premature infants.

Who is the study for?

This trial is for premature infants aged between 48 hours and 21 days with a symptomatic patent ductus arteriosus (sPDA), which is a heart issue that's common in preemies. Infants must be born at gestational ages of 22 to less than 29 weeks. Those with serious heart or lung problems, other conditions affecting their health significantly, or any issues that might rule out participation are not eligible.

What is being tested?

The study compares two approaches to treating sPDA in premature babies: 'Active Treatment' involves medical intervention to close the PDA, while 'Expectant Management' means monitoring the condition without immediate treatment unless it worsens.

What are the potential side effects?

Potential side effects from active treatments could include reactions to medications used to close the PDA such as kidney impairment, bleeding issues, or infections. Expectant management may lead to complications if the PDA doesn't close on its own and becomes worse.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My baby is between 2 days and 3 weeks old.

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My heart condition is classified as sPDA with a small or moderate size.

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My baby was born between 22 and 28 weeks of pregnancy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a known lung malformation.

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I have a heart condition from birth, not including ASD or VSD.

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I have heart or lung problems that affect my daily activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 26 months corrected age

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~26 months corrected age

This trial's timeline: 3 weeks for screening, Varies for treatment, and 26 months corrected age for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Death or Bronchopulmonary Dysplasia (BPD) at 36 weeks PMA

Secondary study objectives

Bronchopulmonary dysplasia - NIH Consensus Definition

Bronchopulmonary dysplasia - Physiological Test

Head Circumference at 36 weeks PMA

+7 more

Other study objectives

Head Circumference at status (2 years)

Height at status (2 years)

Necrotizing Enterocolitis (NEC) at status (2 years)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Group I: Active Treatment GroupActive Control1 Intervention

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.

Group II: Expectant Management GroupActive Control1 Intervention

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

0 / 6Eligibility criteria met