NCT02396004

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 24, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 10, 2017

Status Verified

February 1, 2017

Enrollment Period

2.2 years

First QC Date

March 18, 2015

Last Update Submit

February 9, 2017

Conditions

PDA

Outcome Measures

Primary Outcomes (1)

  • cerebral oximetry

    2 years

Secondary Outcomes (1)

  • renal oximetry

    2 years

Interventions

Near Infrared Red Spectroscopy (NIRS)DEVICE

NIRS using INVOS cerebral/somatic oximeter

Eligibility Criteria

AgeUp to 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

VLBW (defined as birthweight less than 1500g) infants with hemodynamically significant PDA (patent ductus arteriosus) requiring treatment, either medical or surgical

You may qualify if:

  • VLBW infants with hemodynamically significant PDA by echocardiography

You may not qualify if:

  • Major malformation
  • Moribund

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore General Hospital

Singapore, Singapore, 169608, Singapore

Location

Study Officials

  • Woei Bing Poon, MRCPCH

    Singapore General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2015

First Posted

March 24, 2015

Study Start

October 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

February 10, 2017

Record last verified: 2017-02

Locations

SG(1)