Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00554307
Other study ID # UofL IRB 328.07
Secondary ID
Status Withdrawn
Phase N/A
First received November 2, 2007
Last updated January 22, 2015
Start date November 2007
Est. completion date December 2009

Study information

Verified date January 2015
Source University of Louisville
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Federal GovernmentUnited States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The purpose of this study is to determine how the medications which are used to close the patent ductus arteriosus (PDA) in preterm infants affect brain, kidney and gut blood flow when compared to infants that are not treated with these medications. The medications being used for PDA closure are indomethacin and neoprofen.


Description:

All babies requiring medical treatment of their PDA will receive up to 3 doses of medication. For babies enrolled in the control group of this study, she/he will not be treated with either of these medicines.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Less than or equal to 32 weeks gestation;

- Less than or equal to 1250 g;

- Mechanical ventilation;

- Echocardiographic findings of PDA with left to right shunting;

- Medical judgement of neonatologist for medical treatment;

Exclusion Criteria:

- Urine output less than 1 ml/k/hr over previous 12 hours;

- Serum creatinine greater than 1.5 mg/dL;

- Platelet count less than 100,000 per cubic mm;

- Significant skin breakdown at sensor areas;

- Significant congenital anomalies

- Intraventricular hemorrhage greater than or equal to grade III

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Device:
INVOS Cerebral/Somatic oximeter
Placement of sensors on back, abdomen and forehead for measurement of perfusion beginning 1 hour prior to initiation of drug, during medical treatment for PDA and for 24 hours after the last dose. For control infants, monitoring will continue for 48 hours.

Locations

Country Name City State
United States Kosair Children's Hospital Lousiville Kentucky

Sponsors (2)

Lead Sponsor Collaborator
University of Louisville H. Lundbeck A/S

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in blood flow from baseline in infants treated with indomethacin or neoprofen. Blood flow will be measured in the brain, kidney and mesentery. 48-72 hours No
Primary Measure oxygenation/blood flow to brain during PDA treatment Study period No
Secondary Oxygenation during/after treatment with PDA therapy Study period No
See also
  Status Clinical Trial Phase
Recruiting NCT04986839 - PAIR (Paracetamol and Ibuprofen Research) Pilot Trial Phase 2/Phase 3
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
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.
Completed NCT03022253 - Platelet Transfusion for Treatment of Patent Ductus Arteriosus in Thrombocytopenic Preterm Neonates Phase 3