Patent Ductus Arteriosus (PDA) Screening Trial

University of Pennsylvania88 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

Conditions

Ductus Arteriosus, Patent

Interventions

Eligibility

Sex: ALLMax age: 72 Hours

Medical Language ↔ Plain English

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)

Locations (2)

The Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Number of days to regain birth weight.

Time frame: 1-4 weeks

Secondary Outcomes

Treatment for a PDA with indomethacin or surgical ligation.

Time frame: 3-6 months

Necrotising enterocolitis (NEC) or >48 hours of NPO status for suspected NEC or feeding intolerance.

Time frame: 3-6 months

Number of days to 120ml/kg/day of enteral feedings (full feeds).

Time frame: 3-6 months

Ventilator days, number of days of positive airway pressure, and number of days in oxygen.

Time frame: 3-6 months

Worst grade of intraventricular hemorrhage and presence of periventricular leukomalacia.

Time frame: 3-6 months

Confirmed or suspected sepsis.

Time frame: 3-6 months

Worst stage of retinopathy of prematurity.

Time frame: 3-6 months

Day of death or discharge.

Time frame: 3-6 months