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Clinical Trials/NCT02396004
NCT02396004CompletedNot Applicable

Near-Infrared Red Spectroscopy (NIRS) to Measure Cerebral Perfusion During and After Patent Ductus Arteriosus (PDA) Treatment in Very Low Birth Weight (VLBW) Infants

Singapore General Hospital1 site in 1 country30 target enrollmentStarted: October 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
1
Primary Endpoint
cerebral oximetry

Study Overview

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:

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
— to 6 Months (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • VLBW infants with hemodynamically significant PDA by echocardiography

Exclusion Criteria

  • Major malformation

Outcomes

Primary Outcomes

cerebral oximetry

Time Frame: 2 years

Secondary Outcomes

  • renal oximetry(2 years)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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