Clinical trial NCT03456336: Management of the PDA Trial
Official title: Management of the Patent Ductus Arteriosus in Premature Infants Trial (PDA Trial)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Infant, Premature
Patent Ductus Arteriosus
Infant, Newborn, Diseases
Patent Ductus Arteriosus After Premature Birth
Lead sponsor: NICHD Neonatal Research Network
Sponsor class: NETWORK
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2018-03-07
Enrollment: 836
Sex: ALL
Minimum age (years): 48
Maximum age (years): 21
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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).

Eligibility criteria: 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 outcomes:
measure: Death or Bronchopulmonary Dysplasia (BPD) at 36 weeks PMA
timeFrame: birth to 36 week postmenstrual age
Secondary outcomes:
measure: Mortality at 36 weeks PMA
timeFrame: birth to 36 week postmenstrual age
measure: Mortality before discharge
timeFrame: birth to 120 days of life
measure: Bronchopulmonary dysplasia - Physiological Test
timeFrame: birth to 36 week postmenstrual age
measure: Bronchopulmonary dysplasia - NIH Consensus Definition
timeFrame: birth to 36 week postmenstrual age
measure: Necrotizing Enterocolitis (NEC) at 36 weeks PMA
timeFrame: birth to 36 weeks post menstrual age
measure: Retinopathy of Prematurity at 36 weeks PMA
timeFrame: birth to 36 weeks post menstrual age
measure: Receipt of therapies designed to close the PDA
timeFrame: birth to 120 days
measure: Weight at 36 weeks PMA
timeFrame: birth to 36 weeks post menstrual age
measure: Height at 36 weeks PMA
timeFrame: birth to 36 weeks post menstrual age
measure: Head Circumference at 36 weeks PMA
timeFrame: birth to 36 weeks post menstrual age
Other outcomes:
measure: Necrotizing Enterocolitis (NEC) at status (2 years)
timeFrame: 26 months corrected age
measure: Retinopathy of Prematurity at status (2 years)
timeFrame: 26 months corrected age
measure: Weight at status (2 years)
timeFrame: 26 months corrected age
measure: Height at status (2 years)
timeFrame: 26 months corrected age
measure: Head Circumference at status (2 years)
timeFrame: 26 months corrected age
measure: Neurodevelopmental impairment (NDI) at status (2 years)
timeFrame: 26 months corrected age
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: San Diego
country: United States
facility: Sharp Mary Birch Hospital for Women & Newborns
state: California
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Northwestern Lurie Children's Hospital of Chicago
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Jackson
country: United States
facility: University of Mississippi Medical Center - Children's of Mississippi
state: Mississippi
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Durham
country: United States
facility: RTI International
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Case Western Reserve University, Rainbow Babies and Children's Hospital
state: Ohio
city: Columbus
country: United States
facility: Research Institute at Nationwide Children's Hospital
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Providence
country: United States
facility: Brown University - Women and Infants Hospital of Rhode Island
state: Rhode Island
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center at Dallas
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References: