Patent Ductus Arteriosus (PDA) Screening Trial

December 31, 2013 updated by: Sara DeMauro, University of Pennsylvania

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • The Hospital of the University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Pennsylvania Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nondisclosure
Subjects will be randomized to nondisclosure of screening echocardiogram results.
Active Comparator: Disclosure
Subjects will be randomized to disclosure of screening echocardiogram results.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of days to regain birth weight.
Time Frame: 1-4 weeks
1-4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Barbara Schmidt, MD, University of Pennsylvania/Children's Hospital of Philadelphia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

December 1, 2009

First Submitted That Met QC Criteria

December 10, 2009

First Posted (Estimate)

December 14, 2009

Study Record Updates

Last Update Posted (Estimate)

January 3, 2014

Last Update Submitted That Met QC Criteria

December 31, 2013

Last Verified

December 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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