Study Results
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Basic Information
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COMPLETED
30 participants
OBSERVATIONAL
2014-10-31
2016-12-31
Brief Summary
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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
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Near Infrared Red Spectroscopy (NIRS)
NIRS using INVOS cerebral/somatic oximeter
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Moribund
6 Months
ALL
No
Sponsors
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Singapore General Hospital
OTHER
Responsible Party
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Principal Investigators
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Woei Bing Poon, MRCPCH
Role: PRINCIPAL_INVESTIGATOR
Singapore General Hospital
Locations
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Singapore General Hospital
Singapore, Singapore, Singapore
Countries
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Other Identifiers
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CIRB 2013/379/E
Identifier Type: -
Identifier Source: org_study_id
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