ClinicalTrials.Veeva

Menu

NIRS in PDA VLBW Infants

S

Singapore Health Services (SingHealth)

Status

Completed

Conditions

PDA

Treatments

Device: Near Infrared Red Spectroscopy (NIRS)

Study type

Observational

Funder types

Other

Identifiers

NCT02396004
CIRB 2013/379/E

Details and patient eligibility

About

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

Full 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.

Enrollment

30 patients

Sex

All

Ages

Under 6 months old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • VLBW infants with hemodynamically significant PDA by echocardiography

Exclusion criteria

  • Major malformation
  • Moribund

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems