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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Dresden University of Technology.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Dresden University of Technology
ClinicalTrials.gov Identifier:
NCT01186627
First received: August 20, 2010
Last updated: October 13, 2010
Last verified: October 2010

August 20, 2010
October 13, 2010
April 2010
April 2012   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01186627 on ClinicalTrials.gov Archive Site
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Trial to Evaluate a Specified Type of Apgar (TEST-APGAR) Follow Up Study
Trial to Evaluate a Specified Type of Apgar (TEST-APGAR) Follow-Up Study

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

Former preterm infants with a gestational age below 32 weeks which have been included in the TEST-APGAR Study are now screened at a corrected age of 2 years after birth.

  • Premature Birth
  • Mortality
  • Apgar Score
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1500
December 2012
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All preterm infants included in the TEST-APGAR Study

Exclusion Criteria:

  • Missing parental Consent
Both
2 Years to 2 Years
No
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Germany
 
NCT01186627
Test-Apgar Follow-Up
No
Prof. Dr. Mario Ruediger, Dresden University of Technology, Department of Neonatology
Dresden University of Technology
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Principal Investigator: Mario Ruediger Technische Universität Dresden
Dresden University of Technology
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP