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 Technische Universität Dresden.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT01186627
First received: August 20, 2010
Last updated: October 13, 2010
Last verified: October 2010
  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

Ages Eligible for Study:   2 Years to 2 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

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
Study First Received: August 20, 2010
Last Updated: October 13, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

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

ClinicalTrials.gov processed this record on October 20, 2014