Management of the PDA Trial

Phase 3Active Not RecruitingNCT03456336

NICHD Neonatal Research Network836 enrolled

Overview

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

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

836

Conditions

Infant, Premature Patent Ductus Arteriosus Infant, Newborn, Diseases Patent Ductus Arteriosus After Premature Birth

Interventions

Active TreatmentOTHER

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 ManagementOTHER

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

Eligibility

Sex: ALLMin age: 48 HoursMax age: 21 Days

Medical Language ↔ Plain English

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

Locations (19)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

Death or Bronchopulmonary Dysplasia (BPD) at 36 weeks PMA

Death or BPD. BPD will be defined by the physiologic definition.

Time frame: birth to 36 week postmenstrual age

Secondary Outcomes

Mortality at 36 weeks PMA

mortality assessed at 36 week postmenstrual age

Time frame: birth to 36 week postmenstrual age

Mortality before discharge

mortality assessed prior to hospital discharge

Time frame: birth to 120 days of life

Bronchopulmonary dysplasia - Physiological Test

BPD defined by the physiologic test of oxygen therapy

Time frame: birth to 36 week postmenstrual age

Bronchopulmonary dysplasia - NIH Consensus Definition

BPD defined by the NIH consensus definition of moderate or severe

Time frame: birth to 36 week postmenstrual age

Necrotizing Enterocolitis (NEC) at 36 weeks PMA

Proven NEC, no surgery, Stages IIA, IIB, or IIIA AND proven, surgery, Stage IIIB

Time frame: birth to 36 weeks post menstrual age

Retinopathy of Prematurity at 36 weeks PMA

Stage 3 or worse in either eye AND as any intervention therapy-retinal ablation, scleral buckle/vitrectomy, avastin or other anti-VEGF drug

Time frame: birth to 36 weeks post menstrual age

Receipt of therapies designed to close the PDA

Data from ClinicalTrials.gov

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