Brief Title
NIRS in PDA VLBW Infants
Official Title
Near-Infrared Red Spectroscopy (NIRS) to Measure Cerebral Perfusion During and After Patent Ductus Arteriosus (PDA) Treatment in Very Low Birth Weight (VLBW) Infants
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.
Study Type
Observational
Primary Outcome
cerebral oximetry
Secondary Outcome
renal oximetry
Condition
PDA
Intervention
Near Infrared Red Spectroscopy (NIRS)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
30
Start Date
October 2014
Completion Date
December 2016
Primary Completion Date
December 2016
Eligibility Criteria
Inclusion Criteria: - VLBW infants with hemodynamically significant PDA by echocardiography Exclusion Criteria: - Major malformation - Moribund
Gender
All
Ages
N/A - 6 Months
Accepts Healthy Volunteers
No
Contacts
Woei Bing Poon, MRCPCH, ,
Location Countries
Singapore
Location Countries
Singapore
Administrative Informations
NCT ID
NCT02396004
Organization ID
CIRB 2013/379/E
Responsible Party
Sponsor
Study Sponsor
Singapore General Hospital
Study Sponsor
Woei Bing Poon, MRCPCH, Principal Investigator, Singapore General Hospital
Verification Date
February 2017