NCT01665261

Brief Summary

The purpose of this study is to test the accuracy of 7 indicators in screening congenital heart defects (CHD) in all newborns (symptomatic or asymptomatic) to determine whether these indicators could be applied in the nationwide newborn CHD screening. The investigator's hypothesis is that 7 indicators are effective in neonate CHD screening with the acceptable accuracy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6,730

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2012

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

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

July 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 9, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 15, 2012

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

March 11, 2015

Status Verified

March 1, 2015

Enrollment Period

2 months

First QC Date

August 9, 2012

Last Update Submit

March 10, 2015

Conditions

Congenital Heart Disease

Keywords

Congenital heart diseaseNewbornPulse oximetryScreening

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy of the 7 indicators for detection of all CHDs and major CHDs

    Sensitivity, specificity, negative and positive predictive value, negative and positive likelihood ratio of 7 indicators for the detection of all CHDs and major CHDs as gold standard the echocardiography.

    The goldstandard for CHD diagnosis is the echocardiography performed within 1 hour from the screening completed.

Eligibility Criteria

Age6 Hours - 72 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

All consecutive neonates including pre-mature neonates and symptomatic neonates) will be recruited prospectively from two collaboration hospitals of the ongoing projects- "Key Clinical Research Project Sponsored by Ministry of Health Screening, evaluation and intervention of congenital heart disease in newborn infants(2010-239)"

You may qualify if:

  • all consecutive live newborn infants
  • between 6-72hours of age

You may not qualify if:

  • declining the screening;
  • early discharge before the screening;
  • missing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Songjiang District Central Hospital

Shanghai, Shanghai Municipality, 201620, China

Location

Songjiang Maternal and Child Health Hospital

Shanghai, Shanghai Municipality, 201620, China

Location

Related Publications (3)

  • de-Wahl Granelli A, Wennergren M, Sandberg K, Mellander M, Bejlum C, Inganas L, Eriksson M, Segerdahl N, Agren A, Ekman-Joelsson BM, Sunnegardh J, Verdicchio M, Ostman-Smith I. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009 Jan 8;338:a3037. doi: 10.1136/bmj.a3037.

    PMID: 19131383BACKGROUND

  • Ewer AK, Furmston AT, Middleton LJ, Deeks JJ, Daniels JP, Pattison HM, Powell R, Roberts TE, Barton P, Auguste P, Bhoyar A, Thangaratinam S, Tonks AM, Satodia P, Deshpande S, Kumararatne B, Sivakumar S, Mupanemunda R, Khan KS. Pulse oximetry as a screening test for congenital heart defects in newborn infants: a test accuracy study with evaluation of acceptability and cost-effectiveness. Health Technol Assess. 2012;16(2):v-xiii, 1-184. doi: 10.3310/hta16020.

    PMID: 22284744BACKGROUND

  • Mahle WT, Newburger JW, Matherne GP, Smith FC, Hoke TR, Koppel R, Gidding SS, Beekman RH 3rd, Grosse SD; American Heart Association Congenital Heart Defects Committee of the Council on Cardiovascular Disease in the Young, Council on Cardiovascular Nursing, and Interdisciplinary Council on Quality of Care and Outcomes Research; American Academy of Pediatrics Section on Cardiology and Cardiac Surgery, and Committee on Fetus and Newborn. Role of pulse oximetry in examining newborns for congenital heart disease: a scientific statement from the American Heart Association and American Academy of Pediatrics. Circulation. 2009 Aug 4;120(5):447-58. doi: 10.1161/CIRCULATIONAHA.109.192576. Epub 2009 Jul 6.

    PMID: 19581492BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

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

Study Officials

  • Huang G Ying, MD PHD

    Children's Hospital of Fudan University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President of Children's Hospital of Fudan University

Study Record Dates

First Submitted

August 9, 2012

First Posted

August 15, 2012

Study Start

July 1, 2012

Primary Completion

September 1, 2012

Study Completion

February 1, 2013

Last Updated

March 11, 2015

Record last verified: 2015-03

Locations

CN(2)