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NCT01186627 Clinical Trial

Trial to Evaluate a Specified Type of Apgar (TEST-APGAR) Follow Up Study

Premature Birth Clinical Trial

Official title:
Trial to Evaluate a Specified Type of Apgar (TEST-APGAR) Follow-Up Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01186627
Other study ID # Test-Apgar Follow-Up
Secondary ID
Status Recruiting
Phase N/A
First received August 20, 2010
Last updated October 13, 2010
Start date April 2010
Est. completion date December 2012

Study information
Verified date October 2010
Source Technische Universität Dresden
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical Trial Summary

A specified version of the Apgar-Score, that can be used in newborns under resuscitation, was developed and its value to predict chronic damage in preterm infants will be tested.

Description:

Specifications of the individual items of the original Apgar score were suggested. These specifications slightly changed the Apgars' perspective, but did not alter the number of its components. The specified Apgar should therefore be easily applicable to every delivery room around the world. As a result of these specifications, the Apgar score will not express the efforts of the infant but describe its condition, independently of the requirements needed to achieve this condition. The advantage of the proposed definitions is the applicability in all infants, regardless of resuscitative efforts or gestational age.

To validate the accuracy of the specified version to predict neonatal mortality and long term neurological outcome in preterm infants the present prospective, observational study is planned. The study will test the hypothesis that the specified APGAR-score predicts mortality and morbidity better at 2 years of age than the conventional Apgar-score. Furthermore, the predictive reliability of the specified Apgar can be improved in combination with perinatal data respectively with the expanded Apgar version of the AAP/ACOG.

The primary outcome "condition at 2 years of age" is composed of death and a major neurological deficit. In this case "neurological deficit" is defined by the presence of one of the followings characteristics: index of mental development (Bayley Scale II) <85, blindness, deafness, cerebral palsy.

Recruitment information / eligibility
Status Recruiting
Enrollment 1500
Est. completion date December 2012
Est. primary completion date April 2012
Accepts healthy volunteers No
Gender Both
Age group 2 Years to 2 Years
Eligibility Inclusion Criteria:

- All preterm infants included in the TEST-APGAR Study

Exclusion Criteria:

- Missing parental Consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Germany University Hospital Carl Gustav Carus Dresden

Sponsors (1)
Lead Sponsor Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

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