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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01186627
Enrollment
1500
Registered
2010-08-23
Start date
2010-04-30
Completion date
2012-12-31
Last updated
2010-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apgar Score, Mortality, Premature Birth

Keywords

Neurodevelopmental Impairment, Intraventricular hemorrhage, Retinopathy of prematurity, Mortality, Apgar Score

Brief summary

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.

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.

Interventions

None listed

Sponsors

Technische Universität Dresden
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to 2 Years
Healthy volunteers
No

Inclusion criteria

* All preterm infants included in the TEST-APGAR Study

Exclusion criteria

* Missing parental Consent

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026