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| Sponsored by: |
Dresden University of Technology |
|---|---|
| Information provided by: | Dresden University of Technology |
| ClinicalTrials.gov Identifier: | NCT00623038 |
Purpose
It is of importance to predict the risk to develop problems after birth. Virginia Apgar developed a score more than 50 years ago that allows a description of the condition of newborns at 1, 5 and 10 minutes after birth. The Apgar score is used for every newborn, however, its applicability is restricted in ventilated or resuscitated newborns. A specified version of the 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 |
|---|
|
Apgar Score Premature Birth Bronchopulmonary Dysplasia |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Trial to Evaluate a Specified Type of APGAR |
| Estimated Enrollment: | 1500 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Specifications of the individual items of the original Apgar score were suggested. These specifications will slightly change the Apgars' perspective, but will 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 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 than the conventional Apgar-score. Furthermore, the predictive reliability of the specified Apgar is compared with the expanded Apgar version of the AAP/ACOG.
A follow-up study to test how the specified Apgar will predict long term neurological outcome is planned.
Eligibility| Ages Eligible for Study: | up to 1 Minute |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Preterm infants with a gestational age below 32 weeks
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | Dresden University of Technology, Department for Neonatology ( Prof. Dr. Mario Rüdiger ) |
| Study ID Numbers: | TEST-APGAR |
| Study First Received: | February 14, 2008 |
| Last Updated: | February 14, 2008 |
| ClinicalTrials.gov Identifier: | NCT00623038 History of Changes |
| Health Authority: | Austria: Federal Office for Safety in Health Care |
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Neurodevelopmental Impairment Intraventricular hemorrhage Retinopathy of prematurity |
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Bronchopulmonary Dysplasia Pregnancy Complications Respiratory Tract Diseases Obstetric Labor, Premature Lung Diseases Obstetric Labor Complications |
Infant, Newborn, Diseases Infant, Premature, Diseases Retinopathy of Prematurity Hemorrhage Retinal Diseases Premature Birth |
|
Bronchopulmonary Dysplasia Pregnancy Complications Respiratory Tract Diseases Obstetric Labor, Premature Lung Diseases |
Obstetric Labor Complications Infant, Newborn, Diseases Infant, Premature, Diseases Premature Birth |
