NCT02396004

NIRS in PDA VLBW Infants

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Singapore General Hospital · Academic / Other
• Sex: All
• Age: 6 Months
• Healthy volunteers: Not accepted

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.

Conditions

• PDA

Interventions

Type	Name	Description
DEVICE	Near Infrared Red Spectroscopy (NIRS)	NIRS using INVOS cerebral/somatic oximeter

Timeline

• Start date: 2014-10-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2015-03-24
• Last updated: 2017-02-10

Locations

1 site across 1 country: Singapore