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Clinical Trials/NCT02396004
NCT02396004
Completed
Not Applicable

Near-Infrared Red Spectroscopy (NIRS) to Measure Cerebral Perfusion During and After Patent Ductus Arteriosus (PDA) Treatment in Very Low Birth Weight (VLBW) Infants

Singapore General Hospital1 site in 1 country30 target enrollmentOctober 2014
ConditionsPDA

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
PDA
Sponsor
Singapore General Hospital
Enrollment
30
Locations
1
Primary Endpoint
cerebral oximetry
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

Aim of study:

To conduct an observational study to collect cerebral and renal perfusion data through NIRS before and after treatment of PDA by medication or by PDA ligation. The data post treatment would form the basis for normative baseline data in VLBW preterm newborn babies, particularly in the Asian population.

Study population/inclusion criteria:

VLBW newborn babies with hemodynamically significant PDA by echocardiography.

Exclusion criteria:

Major malformations Moribund patients

Detailed Description

Aim of study: To conduct an observational study to collect cerebral and renal perfusion data through NIRS before and after treatment of PDA by medication or by PDA ligation. The data post treatment would form the basis for normative baseline data in VLBW preterm newborn babies, particularly in the Asian population. Study population/inclusion criteria: VLBW newborn babies with hemodynamically significant PDA by echocardiography. Exclusion criteria: Major malformations Moribund patients Protocol: Consent will be obtained from parents of eligible newborns before treatment of hemodynamic significant PDA. To attach cerebral and renal oximeter by NIRS to these VLBW infants with PDAs for until 24 hours post closure of PDA. Doppler ultrasound will be performed on anterior cerebral artery (ACA) and/or middle cerebral artery (MCA) artery and/or renal artery(RA) before PDA treatment and/or 24hours after PDA closure.This study aims to use one of the more popular neonatal/paediatrics NIRS machine, which is the INVOS cerebral/somatic oximeter The same patient will hence form its own control after treatment. Echocardiographic follow-up or clinical assessment for closure of the PDA will be performed 24-48 hours after the course of medication or surgical closure.

Registry
clinicaltrials.gov
Start Date
October 2014
End Date
December 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • VLBW infants with hemodynamically significant PDA by echocardiography

Exclusion Criteria

  • Major malformation

Outcomes

Primary Outcomes

cerebral oximetry

Time Frame: 2 years

Secondary Outcomes

  • renal oximetry(2 years)

Study Sites (1)

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