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

• Conditions: Premature Birth; Mortality; Apgar Score

• Registration Number: NCT01186627
• Lead Sponsor: Technische Universität Dresden

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-08-20
• Study First Submitted QC: 2010-08-20
• Study First Posted: 2010-08-23
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-13
• Last Update Posted: 2010-10-14
• Primary Completion: 2012-04
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

• All preterm infants included in the TEST-APGAR Study

Exclusion Criteria

• Missing parental Consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

University Hospital Carl Gustav Carus; 🇩🇪 Dresden, Germany