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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Premature Birth Mortality Apgar Score

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* All preterm infants included in the TEST-APGAR Study

Exclusion Criteria

* Missing parental Consent

Minimum Eligible Age

2 Years

Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dresden University of Technology, Department of Neonatology

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mario Ruediger

Role: PRINCIPAL_INVESTIGATOR

Technische Universität Dresden

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital Carl Gustav Carus

Dresden, Dresden, Germany

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Germany

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Mario Ruediger, Head of Department

Role: primary

[email protected]

0049-351-458-3640

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Test-Apgar Follow-Up

Identifier Type: -

Identifier Source: org_study_id