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Trial to Evaluate a Specified Type of APGAR (TEST-APGAR)

This study has been completed.
Sponsor:
Information provided by:
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT00623038
First received: February 14, 2008
Last updated: April 21, 2011
Last verified: April 2011
  Purpose

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.


Condition
Postnatal Condition of a Newborn Infant

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Trial to Evaluate a Specified Type of APGAR

Further study details as provided by Technische Universität Dresden:

Primary Outcome Measures:
  • Poor outcome [ Time Frame: Between birth and the day of discharge from first stay in hospital ] [ Designated as safety issue: No ]
    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)


Enrollment: 1855
Study Start Date: March 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   up to 10 Minutes
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Very preterm infants born prior to 32 completed weeks of gestation

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00623038

Sponsors and Collaborators
Technische Universität Dresden
Investigators
Principal Investigator: Mario Ruediger Department of Neonatology and Pediatric Intensive Care, University Hospital Carl Gustav Carus Dresden, Germany
Principal Investigator: Helmut Kuester Department of Neonatology and Pediatric Intensiv Care, Ernst-Moritz-Arndt-University Greifswald, Germany
  More Information

No publications provided

Responsible Party: Prof. Dr. Mario Rüdiger, Dresden University of Technology, Department for Neonatology
ClinicalTrials.gov Identifier: NCT00623038     History of Changes
Other Study ID Numbers: TEST-APGAR
Study First Received: February 14, 2008
Last Updated: April 21, 2011
Health Authority: Austria: Federal Office for Safety in Health Care

Keywords provided by Technische Universität Dresden:
Apgar score
neonatal assessment
preterm infants
resuscitation

ClinicalTrials.gov processed this record on November 19, 2014