Patent Ductus Arteriosus (PDA) Screening Trial

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

Ductus Arteriosus, Patent

Clinical Trial Details

NCT number	NCT01031316
Study type	Interventional
Source	University of Pennsylvania
Contact
Status	Completed
Phase	N/A
Start date	October 2009
Completion date	August 2011

View Details

See also
Status	Clinical Trial	Phase
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Completed	`NCT01251939` - Changes in Renal and Splanchnic Oxygenation During Ibuprofen Treatment for Patent Ductus Arterious	N/A
Completed	`NCT00828334` - NIT-OCCLUD PDA Phase II Sentinel Trial	N/A
Completed	`NCT00009646` - Trial of Indomethacin Prophylaxis in Preterm Infants (TIPP)	Phase 3
Withdrawn	`NCT00470743` - Comparing Ibuprofen And Indomethacin For The Treatment Of The Patent Ductus Arteriosus in Very Premature Babies	Phase 4
Completed	`NCT00725647` - Plasma N-terminal proBNP Concentrations and Patent Ductus Arteriosus in Preterm Babies	N/A
Terminated	`NCT00239512` - New Management Strategy of PDA for VLBW Preterm Infants	N/A
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Completed	`NCT00005190` - Reproduction and Survival After Cardiac Defect Repair	N/A
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Completed	`NCT02422966` - Paracetamol in Patent Ductus Arteriosus	Phase 2
Completed	`NCT02803671` - Analysis of the Impact of Patent Ductus Arteriosus on Brain Function in Preterm Neonates: Multimodal Approach Integrating EEG-NIRS, Ultrasound and Clinical Data	N/A
Completed	`NCT00799123` - Urine NT-proBNP Levels and Echocardiographic Findings in Very Low Birth Weight (VLBW) Infants	N/A
Completed	`NCT00528736` - Plasma B-Type Natriuretic Peptide Concentrations in Preterm Infants < 28 Weeks	N/A
Completed	`NCT02002741` - Adding Paracetamol to Ibuprofen for Treatment of Patent Ductus Arteriosus in Preterm Infants	Phase 2/Phase 3