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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2010 by Technische Universität Dresden.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01186627
First Posted: August 23, 2010
Last Update Posted: October 14, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Technische Universität Dresden
  Purpose
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.

Condition
Premature Birth Mortality Apgar Score

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Trial to Evaluate a Specified Type of Apgar (TEST-APGAR) Follow-Up Study

Resource links provided by NLM:


Further study details as provided by Technische Universität Dresden:

Estimated Enrollment: 1500
Study Start Date: April 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  • All preterm infants included in the TEST-APGAR Study

Exclusion Criteria:

  • Missing parental Consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01186627


Locations
Germany
University Hospital Carl Gustav Carus Recruiting
Dresden, Germany, 01307
Contact: Mario Ruediger, Head of Department    0049-351-458-3640    mario.ruediger@uniklinikum-dresden.de   
Principal Investigator: Mario Ruediger         
Sponsors and Collaborators
Technische Universität Dresden
Investigators
Principal Investigator: Mario Ruediger Technische Universität Dresden
  More Information

Responsible Party: Prof. Dr. Mario Ruediger, Dresden University of Technology, Department of Neonatology
ClinicalTrials.gov Identifier: NCT01186627     History of Changes
Other Study ID Numbers: Test-Apgar Follow-Up
First Submitted: August 20, 2010
First Posted: August 23, 2010
Last Update Posted: October 14, 2010
Last Verified: October 2010

Keywords provided by Technische Universität Dresden:
Neurodevelopmental Impairment
Intraventricular hemorrhage
Retinopathy of prematurity
Mortality
Apgar Score

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications