Patent Ductus Arteriosus (PDA) Screening Trial
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|ClinicalTrials.gov Identifier: NCT01031316|
Recruitment Status : Completed
First Posted : December 14, 2009
Last Update Posted : January 3, 2014
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.
|Condition or disease||Intervention/treatment|
|Ductus Arteriosus, Patent||Other: Nondisclosure of screening echocardiogram results Other: Disclosure of screening echocardiogram results|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||88 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||October 2009|
|Primary Completion Date :||April 2011|
|Study Completion Date :||August 2011|
Other: Nondisclosure of screening echocardiogram results
Subjects will be randomized to nondisclosure of screening echocardiogram results.
|Active Comparator: Disclosure||
Other: Disclosure of screening echocardiogram results
Subjects will be randomized to disclosure of screening echocardiogram results.
- Number of days to regain birth weight. [ Time Frame: 1-4 weeks ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01031316
|United States, Pennsylvania|
|The Hospital of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Philadelphia, Pennsylvania, United States, 19107|
|Study Director:||Barbara Schmidt, MD||University of Pennsylvania/Children's Hospital of Philadelphia|