Brain, Gut and Kidney Blood Flow During Medical Closure of PDA

NCT00554307 | Withdrawn

• 1 other identifier: UofL IRB 328.07
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Patent Ductus Arteriosus

Keywords

patent ductus arteriosus; indomethacin; neoprofen; blood flow

Outcome Measures

Primary Outcomes (2)

• 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

• Measure oxygenation/blood flow to brain during PDA treatment

  Study period

Secondary Outcomes (1)

• Oxygenation during/after treatment with PDA therapy

  Study period

Study Arms (3)

Indo

Infants that are treated with indomethacin

Device: INVOS Cerebral/Somatic oximeter

Neo

Infants treated with neoprofen

Device: INVOS Cerebral/Somatic oximeter

Control

Infants without PDA

Device: INVOS Cerebral/Somatic oximeter

Interventions

INVOS Cerebral/Somatic oximeter DEVICE

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.

Control; Indo; Neo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Preterm infants with patent ductus arteriosus requiring medical intervention

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Louisville: lead
• H. Lundbeck A/S: collaborator

Study Sites (1)

Kosair Children's Hospital

Lousiville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Ductus Arteriosus, Patent

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Dan L Stewart, MD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 2, 2007
• First Posted: November 6, 2007
• Study Start: November 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: January 26, 2015

Record last verified: 2015-01

Locations

US (1)