Patent Ductus Arteriosus (PDA) Screening Trial

Not Applicable

Completed

• Conditions: Ductus Arteriosus, Patent
• Interventions: Other: Nondisclosure of screening echocardiogram results; Other: Disclosure of screening echocardiogram results

• Registration Number: NCT01031316
• Lead Sponsor: University of Pennsylvania

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-12-01
• Study First Submitted QC: 2009-12-10
• Study First Posted: 2009-12-14
• Primary Completion: 2011-04
• Study Completion: 2011-08
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-31
• Last Update Posted: 2014-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nondisclosure	Nondisclosure of screening echocardiogram results	-
Disclosure	Disclosure of screening echocardiogram results	-

Primary Outcome Measures

Name	Time	Method
Number of days to regain birth weight.	1-4 weeks

Secondary Outcome Measures

Name	Time	Method
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
Worst grade of intraventricular hemorrhage and presence of periventricular leukomalacia.	3-6 months
Confirmed or suspected sepsis.	3-6 months
Ventilator days, number of days of positive airway pressure, and number of days in oxygen.	3-6 months
Worst stage of retinopathy of prematurity.	3-6 months
Day of death or discharge.	3-6 months

Trial Locations

Locations (2)

Pennsylvania Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

The Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States