NCT02396004|Completed
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
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Near-Infrared Red Spectroscopy (NIRS) to Measure Cerebral Perfusion During and After Patent Ductus Arteriosus (PDA) Treatment in Very Low Birth Weight (VLBW) Infants
Sponsor study identifier
observational
30
1 country
1
Study Start
October 2014
Actual (reported)Primary Completion
December 2016
Actual (reported)Study Completion
December 2016
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2016
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2014
Actual (reported)March 18, 2015
Actual (reported)March 24, 2015
Actual (reported)December 2016
Actual (reported)December 2016
Actual (reported)cerebral oximetry
2 years
renal oximetry
2 years
NIRS using INVOS cerebral/somatic oximeter
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VLBW (defined as birthweight less than 1500g) infants with hemodynamically significant PDA (patent ductus arteriosus) requiring treatment, either medical or surgical
Singapore General Hospital
Singapore, Singapore, 169608, Singapore
Woei Bing Poon, MRCPCH
Singapore General Hospital
30 participants (actual enrollment reported by the registry).
First Submitted
March 18, 2015
First Posted
March 24, 2015
Study Start
October 2014
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
December 2016
Actual (reported)Study Completion
December 2016
Actual (reported)Last Updated
February 10, 2017
Record last verified: 2017-02
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Source: ClinicalTrials.gov.
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