Clinical trial NCT01031316: Patent Ductus Arteriosus (PDA) Screening Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ductus Arteriosus, Patent
Keywords: Echocardiography
Infant, Premature
Infant, Very Low Birth Weight
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2009-12-14
Enrollment: 88
Sex: ALL
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Number of days to regain birth weight.
timeFrame: 1-4 weeks
Secondary outcomes:
measure: Treatment for a PDA with indomethacin or surgical ligation.
timeFrame: 3-6 months
measure: Necrotising enterocolitis (NEC) or >48 hours of NPO status for suspected NEC or feeding intolerance.
timeFrame: 3-6 months
measure: Number of days to 120ml/kg/day of enteral feedings (full feeds).
timeFrame: 3-6 months
measure: Ventilator days, number of days of positive airway pressure, and number of days in oxygen.
timeFrame: 3-6 months
measure: Worst grade of intraventricular hemorrhage and presence of periventricular leukomalacia.
timeFrame: 3-6 months
measure: Confirmed or suspected sepsis.
timeFrame: 3-6 months
measure: Worst stage of retinopathy of prematurity.
timeFrame: 3-6 months
measure: Day of death or discharge.
timeFrame: 3-6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pennsylvania Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania/Children's Hospital of Philadelphia
name: Barbara Schmidt, MD
role: STUDY_DIRECTOR
References: