Trial to Evaluate a Specified Type of APGAR

Completed

• Conditions: Postnatal Condition of a Newborn Infant

• Registration Number: NCT00623038
• Lead Sponsor: Technische Universität Dresden

Brief Summary

It is of importance to predict the risk to develop problems after birth. Virginia Apgar developed a score more than 50 years ago that allows a description of the condition of newborns at 1, 5 and 10 minutes after birth. The Apgar score is used for every newborn, however, its applicability is restricted in preterm infants and resuscitated newborns. Thus, two scores have been suggested recently - the Specified Apgar and the Expanded-Apgar score. By combining both scores the Combined-Apgar has been developed as a new delivery room tool.

The purpose of this study is to determine whether the Combined-Apgar predicts poor outcome better than the Specified- or Expanded Apgar alone.

Detailed Description

Since the conventional Apgar score has its limitations in preterm or resuscitated infants, specifications of the individual items of the original Apgar score were suggested (Specified Apgar). The Specified-Apgar will slightly change the Apgars' perspective, but will not alter the number of its components. The advantage of the proposed definitions is the applicability in all infants, regardless of resuscitative efforts or gestational age. However, neither the conventional nor the Specified-Apgar score describes the condition of the infant. That problem has been taken up by the American Academy of pediatrics (AAP)and the American College of Obstetricians and Gynecologists (ACOG). They suggested to use an expanded Apgar Score reporting form (Expanded-Apgar)that accounts for concurrent resuscitative interventions. Whereas the Specified-Apgar score describes the condition of the infant, the Expanded-Apgar is a measure of interventions needed to achieve this condition. By combining both scores (Combined-Apgar) the postnatal condition is described in more detail than by a single score alone.

To validate the accuracy of these scores in a population of very preterm infants, the present prospective, observational, international multicenter study is planned. Until today there is no gold standard available to describe infant's conditions and interventions. For the evaluation of the scores it was therefore hypothesized that the Combined Apgar predicts poor outcome (defined as either death or any major morbidity) better than the Specified Apgar or Expanded Apgar alone. Prediction of poor outcome was used as a surrogate parameter to test the predictive value of the Combined-Apgar score in a clinical setting for preterm infants. In an attempt to determine how strong of an association there is between the Combined Apgar Score and neurologic impairment in early childhood, we are presently engaged in a long-term follow-up of all surviving infants at a corrected age of 24 months.

Study Timeline

• Study First Submitted: 2008-02-14
• Study First Submitted QC: 2008-02-14
• Study First Posted: 2008-02-25
• Study Start: 2008-03
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-21
• Last Update Posted: 2011-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1855

Inclusion Criteria

• gestational age below 32 weeks
• born within the study centres

Exclusion Criteria

• missing informed consent
• outborn
• major congenital abnormalities
• death in the delivery room

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Poor outcome	Between birth and the day of discharge from first stay in hospital	Poor outcome is defined as death or the presence of either of the major morbidities: bronchopulmonary dysplasia (BPD), intraventricular hemorrhage (IVH) grade 1-4, cystic periventricular leucomalcia (CPL), retinopathy of prematurity (ROP)