PDA Clinical Trial
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
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
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.
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