Clinical trial NCT00623038: Trial to Evaluate a Specified Type of APGAR
Official title: Trial to Evaluate a Specified Type of APGAR
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postnatal Condition of a Newborn Infant
Keywords: Apgar score
neonatal assessment
preterm infants
resuscitation
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2008-02-25
Enrollment: 1855
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Very preterm infants born prior to 32 completed weeks of gestation

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.

Eligibility criteria: 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

Primary outcomes:
measure: Poor outcome
timeFrame: Between birth and the day of discharge from first stay in hospital
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Neonatology and Pediatric Intensive Care, University Hospital Carl Gustav Carus Dresden, Germany
name: Mario Ruediger
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Neonatology and Pediatric Intensiv Care, Ernst-Moritz-Arndt-University Greifswald, Germany
name: Helmut Kuester
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rudiger M, Braun N, Aranda J, Aguar M, Bergert R, Bystricka A, Dimitriou G, El-Atawi K, Ifflaender S, Jung P, Matasova K, Ojinaga V, Petruskeviciene Z, Roll C, Schwindt J, Simma B, Staal N, Valencia G, Vasconcellos MG, Veinla M, Vento M, Weber B, Wendt A, Yigit S, Zotter H, Kuster H; TEST-Apgar Study-Group. Neonatal assessment in the delivery room--Trial to Evaluate a Specified Type of Apgar (TEST-Apgar). BMC Pediatr. 2015 Mar 8;15:18. doi: 10.1186/s12887-015-0334-7.