NCT01031316

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 72 Hours
• Healthy volunteers: Not accepted

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.

Conditions

• Ductus Arteriosus, Patent

Interventions

Type	Name	Description
OTHER	Nondisclosure of screening echocardiogram results	Subjects will be randomized to nondisclosure of screening echocardiogram results.
OTHER	Disclosure of screening echocardiogram results	Subjects will be randomized to disclosure of screening echocardiogram results.

Timeline

• Start date: 2009-10-01
• Primary completion: 2011-04-01
• Completion: 2011-08-01
• First posted: 2009-12-14
• Last updated: 2014-01-03

Locations

2 sites across 1 country: United States