Patent Ductus Arteriosus (PDA) Screening Trial

Study Overview
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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.

Official Title
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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

Conditions
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Ductus Arteriosus, Patent

Intervention / Treatment
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* Other: Nondisclosure of screening echocardiogram results
* Other: Disclosure of screening echocardiogram results


Participation Criteria
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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)

Ages Eligible for Study
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Maximum Age: 72 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nondisclosure<br> | Other: Nondisclosure of screening echocardiogram results<br>* Subjects will be randomized to nondisclosure of screening echocardiogram results.<br>|
| Active Comparator: Disclosure<br> | Other: Disclosure of screening echocardiogram results<br>* Subjects will be randomized to disclosure of screening echocardiogram results.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days to regain birth weight. |  | 1-4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment for a PDA with indomethacin or surgical ligation. |  | 3-6 months | 
| 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 | 
| Worst grade of intraventricular hemorrhage and presence of periventricular leukomalacia. |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Echocardiography, Infant, Premature, Infant, Very Low Birth Weight