Patent Ductus Arteriosus (PDA) Screening Trial

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

• Status: Completed
• Conditions: Ductus Arteriosus, Patent
• Intervention / Treatment: Other: Nondisclosure of screening echocardiogram results; Other: Disclosure of screening echocardiogram results

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 years (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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

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

Terms related to this study

• Keywords: Infant, Premature; Echocardiography; Infant, Very Low Birth Weight
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Ductus Arteriosus, Patent
• Other Study ID Numbers: 810241