Ductus Arteriosus, Patent
Conditions
Keywords
Echocardiography, Infant, Premature, Infant, Very Low Birth Weight
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.
Interventions
OTHERNondisclosure of screening echocardiogram results
Subjects will be randomized to nondisclosure of screening echocardiogram results.
OTHERDisclosure of screening echocardiogram results
Subjects will be randomized to disclosure of screening echocardiogram results.
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 72 Hours
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of days to regain birth weight. | 1-4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Necrotising enterocolitis (NEC) or >48 hours of NPO status for suspected NEC or feeding intolerance. | 3-6 months |
| Number of days to 120ml/kg/day of enteral feedings (full feeds). | 3-6 months |
| Ventilator days, number of days of positive airway pressure, and number of days in oxygen. | 3-6 months |
| Treatment for a PDA with indomethacin or surgical ligation. | 3-6 months |
| Confirmed or suspected sepsis. | 3-6 months |
| Worst stage of retinopathy of prematurity. | 3-6 months |
| Day of death or discharge. | 3-6 months |
| Worst grade of intraventricular hemorrhage and presence of periventricular leukomalacia. | 3-6 months |
Countries
United States
Outcome results
None listed