NIRS in PDA VLBW Infants

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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