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

Comparison of Cerebral, Renal and Mesenteric Perfusion Using Near Infrared Spectroscopy in Neonates During Patent Ductus Arteriosus Closure With Ibuprofen or Indomethacin.

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00554307

Enrollment

Registered

2007-11-06

Start date

2007-11-30

Completion date

2009-12-31

Last updated

2015-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patent Ductus Arteriosus

Keywords

patent ductus arteriosus, indomethacin, neoprofen, blood flow

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.

Detailed 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.

Interventions

DEVICEINVOS 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Oxygenation during/after treatment with PDA therapy	Study period

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026