Patent Ductus Arteriosus (PDA) Screening Trial
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Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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)
Trial design
Primary purpose
Allocation
Interventional model
Masking
88 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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