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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 26 months corrected age
Awards & highlights
PDA 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.Check my eligibility
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.See study design
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.
PDA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My baby is between 2 days and 3 weeks old.
Select...
My heart condition is classified as sPDA with a small or moderate size.
Select...
My baby was born between 22 and 28 weeks of pregnancy.
PDA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 26 months corrected age
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~26 months corrected age
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Death or Bronchopulmonary Dysplasia (BPD) at 36 weeks PMA
Secondary outcome measures
Bronchopulmonary dysplasia - NIH Consensus Definition
Bronchopulmonary dysplasia - Physiological Test
Head Circumference at 36 weeks PMA
+7 moreOther outcome measures
Head Circumference at status (2 years)
Height at status (2 years)
Necrotizing Enterocolitis (NEC) at status (2 years)
+3 morePDA 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.
Find a Location
Who is running the clinical trial?
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,965 Previous Clinical Trials
2,671,961 Total Patients Enrolled
NICHD Neonatal Research NetworkLead Sponsor
59 Previous Clinical Trials
204,934 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a known lung malformation.My baby is between 2 days and 3 weeks old.I have a heart condition from birth, not including ASD or VSD.I have heart or lung problems that affect my daily activities.My heart condition is classified as sPDA with a small or moderate size.You have a specific heart condition called sPDA, which can be seen on an echocardiogram.My baby was born between 22 and 28 weeks of pregnancy.
Research Study Groups:
This trial has the following groups:- Group 1: Active Treatment Group
- Group 2: Expectant Management Group
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Active Treatment Group been cleared by the FDA?
"There is some clinical evidence to support Active Treatment Group's efficacy, and it has undergone multiple rounds of testing to confirm its safety. Consequently, it received a score of 3."
Answered by AI
Are people of a certain age group excluded from participating in this research?
"This trial is accepting people who are younger than 21 days old and have been 48 hours since their birth."
Answered by AI
I am interested in enrolling in this research, who should I talk to?
"Currently, this study is looking for 1116 participants that were born with an infant, newborn, disease. The age bracket for participants is 48 Hours to 21 Days. To meet the requirements for this study, candidates must: Infant 22 0/7 to 28 6/7 weeks gestation at birth, Postnatal age 48 hours -21 days."
Answered by AI
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