Patent Ductus Arteriosus (PDA) Screening Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sara DeMauro, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01031316
First received: December 1, 2009
Last updated: December 31, 2013
Last verified: December 2013
  Purpose

The ductus arteriosus directs blood away from the pulmonary circulation and toward the systemic circulation during fetal life, then closes after birth. In preterm infants the incidence of spontaneous closure decreases with gestational age. Patent ductus arteriosus (PDA) increases the risks of bronchopulmonary dysplasia (BPD) and necrotizing enterocolitis (NEC). However, this association may not be a causal relationship.

Echocardiography is required to diagnose PDA. However, routine screening echocardiograms lead to detection of asymptomatic PDAs, for which the benefit of therapy remains unproven.

A randomized controlled trial has been designed in which 88 infants with birth weight less than or equal to 1250 grams and gestational age less than or equal to 30 weeks will be enrolled. The investigators' goal is to determine how screening echocardiography influences clinical management and outcomes in these infants.


Condition Intervention
Ductus Arteriosus, Patent
Other: Nondisclosure of screening echocardiogram results
Other: Disclosure of screening echocardiogram results

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: The Role of Serial Echocardiography to Detect an Asymptomatic Patent Ductus Arteriosus (PDA) in Very Low Birth Weight (VLBW) Infants: A Pilot Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Number of days to regain birth weight. [ Time Frame: 1-4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Treatment for a PDA with indomethacin or surgical ligation. [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]
  • Necrotising enterocolitis (NEC) or >48 hours of NPO status for suspected NEC or feeding intolerance. [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]
  • Number of days to 120ml/kg/day of enteral feedings (full feeds). [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]
  • Ventilator days, number of days of positive airway pressure, and number of days in oxygen. [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]
  • Worst grade of intraventricular hemorrhage and presence of periventricular leukomalacia. [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]
  • Confirmed or suspected sepsis. [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]
  • Worst stage of retinopathy of prematurity. [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]
  • Day of death or discharge. [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]

Enrollment: 88
Study Start Date: October 2009
Study Completion Date: August 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nondisclosure Other: Nondisclosure of screening echocardiogram results
Subjects will be randomized to nondisclosure of screening echocardiogram results.
Active Comparator: Disclosure Other: Disclosure of screening echocardiogram results
Subjects will be randomized to disclosure of screening echocardiogram results.

  Eligibility

Ages Eligible for Study:   up to 72 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • birth weight less than or equal to 1250 grams
  • gestational age less than or equal to 30 weeks
  • postnatal age less than or equal to 72 hours
  • have a guardian or acceptable surrogate capable of giving consent on his/her behalf

Exclusion Criteria:

  • not considered viable
  • dysmorphic features or congenital malformations that adversely affect growth
  • have known or suspected congenital heart disease (other than PDA)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01031316

Locations
United States, Pennsylvania
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
University of Pennsylvania
Investigators
Study Director: Barbara Schmidt, MD University of Pennsylvania/Children's Hospital of Philadelphia
  More Information

No publications provided

Responsible Party: Sara DeMauro, Assistant Professor of Pediatrics, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01031316     History of Changes
Other Study ID Numbers: 810241
Study First Received: December 1, 2009
Last Updated: December 31, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Echocardiography
Infant, Premature
Infant, Very Low Birth Weight

Additional relevant MeSH terms:
Ductus Arteriosus, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on April 23, 2014