The Use of B-type Natriuretic Peptide (BNP) to Predict Closure of a Patent Ductus Arteriosus (PDA) in Premature Infants

A patent ductus arteriosus (PDA) is associated with increased morbidity in premature infants. Standard indomethacin treatment is associated with intestinal and renal morbidity. B-type natriuretic peptide is elevated in significant PDAs. This study will determine whether BNP guided therapy could reduce doses of indomethacin.

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Key information

Conditions

Indomethacin Therapy Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Ductus Arteriosus, Patent Heart Defects, Congenital Heart Diseases Patent Ductus Arteriosus

Age range

Up to 4 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Infants with echocardiographically confirmed PDA
Infants determined by attending physician to require PDA closure

Exclusion criteria

infants with congenital hearts disease
infants with creatinine value > 2.0

Treatment and study plan

Withhold standard INDO dose if BNP < 100 pg/ml

Procedure

Primary outcomes

Number of indomethacin doses given on study

Time frame: 2 days

Secondary outcomes

rate of PDA ligation

Time frame: Discharge from NICU
Rate of Chronic lung disease

Time frame: 36 weeks corrected gestational age

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Important dates

Study start: 2004
Study completion: 2007
First posted: Jul 12, 2007
Registry last updated: May 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed