Management of the PDA Trial

Infant, Premature Clinical Trial

— PDA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03456336
• Other study ID #: NICHD-NRN-0059
• Secondary ID: UG1HD112079UG1HD
• Status: Recruiting
• Phase: Phase 3
• Start date: December 3, 2018
• Est. completion date: March 2029

Study information

• Verified date: March 2024
• Source: NICHD Neonatal Research Network
• Contact: Matthew Laughon, MD, MPH
• Phone: 984-974-5063
• Email: matt_laughon[@]med.unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 836
• Est. completion date: March 2029
• Est. primary completion date: March 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 48 Hours to 21 Days

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Active Treatment
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
Infants assigned to the expectant management group will receive indomethacin or ibuprofen if cardiopulmonary compromise occurs.

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico
United States	Emory University	Atlanta	Georgia
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Northwestern Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	Cincinnati Children's Medical Center	Cincinnati	Ohio
United States	Case Western Reserve University, Rainbow Babies and Children's Hospital	Cleveland	Ohio
United States	Research Institute at Nationwide Children's Hospital	Columbus	Ohio
United States	University of Texas Southwestern Medical Center at Dallas	Dallas	Texas
United States	Duke University	Durham	North Carolina
United States	RTI International	Durham	North Carolina
United States	University of Texas Health Science Center at Houston	Houston	Texas
United States	University of Iowa	Iowa City	Iowa
United States	University of Mississippi Medical Center - Children's of Mississippi	Jackson	Mississippi
United States	Stanford University	Palo Alto	California
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Brown University - Women and Infants Hospital of Rhode Island	Providence	Rhode Island
United States	University of Rochester	Rochester	New York
United States	University of Utah	Salt Lake City	Utah
United States	Sharp Mary Birch Hospital for Women & Newborns	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
NICHD Neonatal Research Network	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Necrotizing Enterocolitis (NEC) at status (2 years)	Proven NEC, no surgery, Stages IIA, IIB, or IIIA AND proven, surgery, Stage IIIB	26 months corrected age
Other	Retinopathy of Prematurity at status (2 years)	Stage 3 or worse in either eye AND as any intervention therapy-retinal ablation, scleral buckle/vitrectomy, avastin or other anti-VEGF drug	26 months corrected age
Other	Weight at status (2 years)	Weight assessed at status (2 years)	26 months corrected age
Other	Height at status (2 years)	Height assessed at status (2 years)	26 months corrected age
Other	Head Circumference at status (2 years)	Head Circumference assessed at status (2 years)	26 months corrected age
Other	Neurodevelopmental impairment (NDI) at status (2 years)	Severe NDI will be defined by any of the following: a 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.	26 months corrected age
Primary	Death or Bronchopulmonary Dysplasia (BPD) at 36 weeks PMA	Death or BPD. BPD will be defined by the physiologic definition.	birth to 36 week postmenstrual age
Secondary	Mortality at 36 weeks PMA	mortality assessed at 36 week postmenstrual age	birth to 36 week postmenstrual age
Secondary	Mortality before discharge	mortality assessed prior to hospital discharge	birth to 120 days of life
Secondary	Bronchopulmonary dysplasia - Physiological Test	BPD defined by the physiologic test of oxygen therapy	birth to 36 week postmenstrual age
Secondary	Bronchopulmonary dysplasia - NIH Consensus Definition	BPD defined by the NIH consensus definition of moderate or severe	birth to 36 week postmenstrual age
Secondary	Necrotizing Enterocolitis (NEC) at 36 weeks PMA	Proven NEC, no surgery, Stages IIA, IIB, or IIIA AND proven, surgery, Stage IIIB	birth to 36 weeks post menstrual age
Secondary	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	birth to 36 weeks post menstrual age
Secondary	Receipt of therapies designed to close the PDA	Defined as ligation or cardiac catheterization	birth to 120 days
Secondary	Weight at 36 weeks PMA	Weight assessed at 36 weeks post menstrual age	birth to 36 weeks post menstrual age
Secondary	Height at 36 weeks PMA	Height assessed at 36 weeks post menstrual age	birth to 36 weeks post menstrual age
Secondary	Head Circumference at 36 weeks PMA	Head Circumference assessed at 36 weeks post menstrual age	birth to 36 weeks post menstrual age

External Links

•   NRN Website