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Active, Not Recruiting

NCT Number: NCT03456336

Management of the PDA Trial

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Infant, Premature Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Ductus Arteriosus, Patent Female Urogenital Diseases and Pregnancy Complications Heart Defects, Congenital Heart Diseases Infant, Newborn, Diseases Obstetric Labor Complications Obstetric Labor, Premature Patent Ductus Arteriosus Patent Ductus Arteriosus After Premature Birth Pregnancy Complications Premature Birth Urogenital Diseases

Age range

48 hour–21 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Postnatal age 48 hours -21 days
  • Infant 22 0/7 to 28 6/7 weeks gestation at birth
  • sPDA, as defined as:
  • Mild, Moderate, or Severe Clinical Criteria with Small or Moderate size PDA on echocardiogram
  • 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

Treatment and study plan

Active Treatment

Other

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 Management

Other

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

Primary outcomes

  1. Death or Bronchopulmonary Dysplasia (BPD) at 36 Weeks PMA

    Time frame: Randomization to 36 weeks PMA

    A composite outcome for infants who were diagnosed with physiologic bronchopulmonary dysplasia (BPD) or died by 36 weeks postmenstrual age (PMA). Physiologic BPD is determined using existing Neonatal Research Network Generic Database criteria at 36 weeks PMA. Infants alive an in hospital are classified based on respiratory status at 36 weeks PMA or by a room air weaning challenge performed between 36 and 37 weeks PMA. Infants who are transferred or discharged before 36 weeks are classified based on the support they are receiving at that time. Infants who died before 36 weeks PMA are not assessed for BPD. Deaths include all-cause deaths between randomization and 36 weeks PMA.

Secondary outcomes

  1. Mortality at 36 Weeks PMA

    Time frame: birth to 36 week postmenstrual age

    mortality assessed at 36 week postmenstrual age

  2. Mortality Before Discharge

    Time frame: birth to 120 days of life

    mortality assessed prior to hospital discharge

  3. Bronchopulmonary Dysplasia - Physiological Test

    Time frame: birth to 36 week postmenstrual age

    BPD defined by the physiologic test of oxygen therapy

  4. Bronchopulmonary Dysplasia - NIH Consensus Definition

    Time frame: birth to 36 week postmenstrual age

    BPD defined by the NIH consensus definition of moderate or severe

  5. Necrotizing Enterocolitis (NEC) at 36 Weeks PMA

    Time frame: birth to 36 weeks post menstrual age

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

  6. Retinopathy of Prematurity at 36 Weeks PMA

    Time frame: birth to 36 weeks post menstrual age

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

  7. Receipt of Therapies Designed to Close the PDA

    Time frame: birth to 120 days

    Defined as ligation or cardiac catheterization

  8. Weight at 36 Weeks PMA

    Time frame: birth to 36 weeks post menstrual age

    Weight assessed at 36 weeks post menstrual age

  9. Height at 36 Weeks PMA

    Time frame: birth to 36 weeks post menstrual age

    Height assessed at 36 weeks post menstrual age

  10. Head Circumference at 36 Weeks PMA

    Time frame: birth to 36 weeks post menstrual age

    Head Circumference assessed at 36 weeks post menstrual age

Other outcomes

  1. Necrotizing Enterocolitis (NEC) at Status (2 Years)

    Time frame: 26 months corrected age

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

  2. Retinopathy of Prematurity at Status (2 Years)

    Time frame: 26 months corrected age

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

  3. Weight at Status (2 Years)

    Time frame: 26 months corrected age

    Weight assessed at status (2 years)

  4. Height at Status (2 Years)

    Time frame: 26 months corrected age

    Height assessed at status (2 years)

  5. Head Circumference at Status (2 Years)

    Time frame: 26 months corrected age

    Head Circumference assessed at status (2 years)

  6. Neurodevelopmental Impairment (NDI) at Status (2 Years)

    Time frame: 26 months corrected age

    Severe NDI will be defined by any of the following: a Bayley Scales of Infant and Toddler Development (BSID) III cognitive score < 70, Gross Motor Functional (GMF) Level of 3-5, blindness (<20/200 vision) or profound hearing loss (inability to understand commands despite amplification); moderate NDI will be defined as a BSID III cognitive score 70-84 and either a GMF level of 2 or a hearing deficit requiring amplification to understand commands or unilateral blindness; mild NDI will be defined by a cognitive score 70-84, or a cognitive score ≥ 85 and any of the following: presence of a GMF level 1 or hearing loss not requiring amplification. Normal (no NDI) will be defined by a cognitive score ≥ 85 and absence of any neurosensory deficits.

Sponsors and collaborators

Lead sponsor

NICHD Neonatal Research Network

Network

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Management of the Patent Ductus Arteriosus in Premature Infants Trial (PDA Trial)

Acronym: PDA

Important dates

Study start
2019
Primary completion
2025
Study completion
2027
First posted
Mar 7, 2018
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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