Management of the PDA Trial

NICHD Neonatal Research Network

Status and phase: Active, not recruiting; Phase 3

Conditions: Patent Ductus Arteriosus After Premature Birth; Infant, Premature; Infant, Newborn, Diseases; Patent Ductus Arteriosus

Treatments: Other: Active Treatment; Other: Expectant Management

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT03456336

UG1HD112097 (U.S. NIH Grant/Contract)

UG1HD112079 (U.S. NIH Grant/Contract)

NICHD-NRN-0059

UG1HD112100 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full description

This is a pragmatic randomized multicenter, effectiveness study comparing active treatment of a symptomatic patent ductus arteriosus (sPDA) to expectant management. We hypothesize in premature infants with a sPDA, expectant management reduces the incidence proportion of death or BPD by 10% (from 50% to 40%) when compared to active treatment.

Participants with a sPDA allocated to the active treatment arm will receive intravenous administration of indomethacin or ibuprofen (depending on center preference). The decision to ligate will be left to the clinical team. Participants with a sPDA allocated to the expectant management arm will receive supportive care at the clinical team's discretion and will receive indomethacin/ibuprofen or ligation if the infant develops cardiopulmonary compromise. The decision to ligate will be left to the clinical team.

The primary endpoint for the study will be death or BPD (as assessed by the physiologic definition) at 36 weeks postmenstrual age (PMA).

Enrollment: 836 estimated patients

Sex: All

Ages: 48 hours to 21 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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836 participants in 2 patient groups

Active Treatment Group

Active Comparator group

Description:

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.

Treatment:

Other: Active Treatment

Expectant Management Group

Active Comparator group

Description:

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

Treatment:

Other: Expectant Management