NCT02731248

Brief Summary

Pulse oximetry screening of newborn infants increases early detection of critical congenital heart disease and minimises the risk of circulatory collapse before surgery. This study provides an update on the implementation of pulse oximetry screening in Turkey

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

6 active sites

Status
unknown

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

April 1, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 2, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 7, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

April 7, 2016

Status Verified

April 1, 2016

Enrollment Period

1 year

First QC Date

April 2, 2016

Last Update Submit

April 2, 2016

Conditions

Congenital Heart Disease

Outcome Measures

Primary Outcomes (1)

  • pulse oximeter positivity

    Congenital heart disease detection by pulse oximeter

    6 months

Secondary Outcomes (1)

  • echocardiographic confirmation

    12 months

Interventions

Prospective screening studyOTHER

Prospective screening study in newborns

Eligibility Criteria

Age1 Day - 5 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Babies within the first 24-72 hours followed up in well baby nurseries

You may qualify if:

  • Babies within the first 24-72 hours followed up in well baby nurseries
  • Babies prior to discharge, if discharged before 24 hours of age,
  • Babies ≤5 days and still followed up in well baby nurseries
  • Babies born ≥35 gestational weeks

You may not qualify if:

  • Babies within the first 12 hours of life
  • Babies \>5 days of life
  • Babies with a gestational age of \>35 weeks
  • Babies with major congenital anomaly except congenial heart disease
  • Babies who had a prenatal diagnosis of congenital heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Dr Sami Ulus Children Hospital

Ankara, Ankara, 06120, Turkey (Türkiye)

RECRUITING

Bursa Sevket Yılmaz Training and Research Hospital

Bursa, Turkey (Türkiye)

RECRUITING

Ataturk University Medical Faculty

Erzurum, Turkey (Türkiye)

RECRUITING

Mersin Maternity Hospital

Mersin, Turkey (Türkiye)

RECRUITING

Mugla Sıtkı Koçman University Medical Faculty

Muğla, Turkey (Türkiye)

RECRUITING

Urfa Maternity Hospital

Sanliurfa, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Dilek Dilli, Assoc Prof

    DR sami Ulus Training and Research Hospital

    STUDY CHAIR

Central Study Contacts

Dilek Dilli, Assoc Prof

CONTACT

+905422368250

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc Prof

Study Record Dates

First Submitted

April 2, 2016

First Posted

April 7, 2016

Study Start

April 1, 2016

Primary Completion

April 1, 2017

Study Completion

May 1, 2017

Last Updated

April 7, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(6)