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NCT00500305 Clinical Trial

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

Patent Ductus Arteriosus Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00500305
Other study ID # 10946
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2004
Est. completion date March 2007

Study information
Verified date May 2018
Source University of Virginia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date March 2007
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group N/A to 4 Months
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Withhold standard INDO dose if BNP < 100 pg/ml

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Virginia

Outcome
Type Measure Description Time frame Safety issue
Primary Number of indomethacin doses given on study 2 days
Secondary rate of PDA ligation Discharge from NICU
Secondary Rate of Chronic lung disease 36 weeks corrected gestational age
See also
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Recruiting NCT03648437 - Paracetamol And Ibuprofen/Indomethacin in Closing Patent Ductus Arteriosus Phase 1
Completed NCT04126512 - Timing of Surgical PDA Ligation and Neonatal Outcomes
Not yet recruiting NCT06045130 - PUFAs in Preterm Infants
Completed NCT00217191 - Ibuprofen and Renal Function in Premature Infants Phase 4
Not yet recruiting NCT02894970 - A New Device for Measuring of Lung Photoplethysmography and Pulmonic Arterial Saturation N/A
Completed NCT02621528 - Lifetech CeraFlex™ Post-Market Surveillance Study N/A
Completed NCT03551600 - Splanchnic and Renal Tissue Oxygenation During Enteral Feedings in Neonates With Patent Ductus Arteriosus
Terminated NCT03982342 - Preliminary Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low-weight Infants N/A
Completed NCT01479218 - Safety and Effectiveness Study With a New PDA Occluder for Closure of Patent Ductus Arteriosus N/A
Completed NCT00795990 - Timing for the Medical Treatment of Patent Ductus Arteriosus in Preterm Infants N/A
Terminated NCT00802685 - Timing of PDA Closure and Respiratory Outcome in Premature Infants N/A
Withdrawn NCT00554307 - Brain, Gut and Kidney Blood Flow During Medical Closure of PDA N/A
Completed NCT03723889 - Patent Ductus Arteriosus and Splanchnic Oxygenation at First Feed
Recruiting NCT04397913 - Population Pharmacokinetics and Dosage Individualization of Paracetamol and Ibuprofen in Children With PDA
Completed NCT02750228 - PDA Post NICU Discharge
Recruiting NCT02220270 - Hyperion™ International Registry Trial N/A
Completed NCT01593163 - Echocardiographically Guided Versus Standard Ibuprofen Treatment for Patent Ductus Arteriosus Phase 3
Recruiting NCT06298344 - The Role of Thiamine After Transcatheter Closure in Children With Left-to-Right Shunt Congenital Heart Disease Early Phase 1
Completed NCT03277768 - Non-Invasive Detection of Tissue Oxygen Deprivation in Premature Infants With Patent Ductus Arteriosus.