Patent Ductus Arteriosus (PDA) Screening Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Ductus Arteriosus, Patent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Nondisclosure

Group Type EXPERIMENTAL

Nondisclosure of screening echocardiogram results

Intervention Type OTHER

Subjects will be randomized to nondisclosure of screening echocardiogram results.

Disclosure

Group Type ACTIVE_COMPARATOR

Disclosure of screening echocardiogram results

Intervention Type OTHER

Subjects will be randomized to disclosure of screening echocardiogram results.

Interventions

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Nondisclosure of screening echocardiogram results

Subjects will be randomized to nondisclosure of screening echocardiogram results.

Intervention Type OTHER

Disclosure of screening echocardiogram results

Subjects will be randomized to disclosure of screening echocardiogram results.

Intervention Type OTHER

Eligibility Criteria

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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)

Maximum Eligible Age

72 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No