Apgar-Score in Asphyxiated Infants Under Resuscitation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Technische Universität Dresden.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT01193751
First received: September 1, 2010
Last updated: February 17, 2011
Last verified: September 2010
  Purpose

The specified Apgar-Score in combination with the AAP-Score predicts the morbidity and mortality of asphyxiated newborns.


Condition
Death
Neurodevelopmental Impairment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Multicenter Study to Evaluate the Validity of the Specified Apgar-score in Asphyxiated Infants Under Resuscitation

Further study details as provided by Technische Universität Dresden:

Primary Outcome Measures:
  • Death or Neurologic impairment [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: September 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
asphyxiated newborns > 37 weeks of gestation

Detailed Description:

In the first place the Apgar-score helps to evaluate the postnatal adaptation of the newborn and is used as an index for resuscitative interventions. However, it has been shown in the past that the score has its limits and may be influenced by several factors such as the variability of the examiner, drugs, parental age, neurological impairment of the child as well as premature delivery. Previous studies have proven, however, that the evaluation of the infant's condition with the conventional Apgar-score is affected due to non-uniform definitions.

For this, an explanation might be that on the one hand the inaccuracy of the score is based on missing guidelines for the assessment of the score in premature infants. Both, muscle tone and reflexes of extremely premature infants are physiologically more immature than they are in term newborns. In conclusion, healthy premature infants often achieve a lower Apgar-score than their term counterparts. However, this is rather an expression of their immaturity than a sign for postnatal depression.

Another reason for the inaccuracy of the score might have its origin in the limited comparability and validity of the Apgar-score when applied in resuscitated newborns. Until now there is no consensus how to assess the condition of the newborn under resuscitation, since the individual characteristics composing the score are affected by the resuscitation itself. For example, heart frequency and skin colour are improved by sufficient ventilation. So far there are no regulations on how this fact should be considered while assessing the score. A description of the infant's condition without interventions respectively with interruption of the interventions applied would be in contrast to Apgar's intention to have a score "which could be determined easily without interfering with the care of the infant". The description of the condition independently of the interventions applied offers a practicable alternative. By using this method the resuscitation will not be interrupted and the score will not express the efforts of the infant but describe its condition, independently of the requirements needed to achieve this condition.

To validate the accuracy of the specified version of the Apgar-score to predict neonatal mortality and long term outcome in preterm infants, the multicenter TEST-Apgar study has been performed recently.

The American Academy of Pediatrics (AAP) is also aware of the problem concerning the description of resuscitated newborns. As a solution, it was suggested to use an expanded Apgar-score reporting form that accounts for concurrent resuscitative interventions (AAP-Score). This way the infant's condition can be estimated and documented more easily. Although the AAP-Score has been suggested 4 years ago, data on the predictive reliability are not available yet. This aspect regarding the neonatal mortality of premature infants has also been analyzed in the TEST-Apgar study. The results show that the specified Apgar-Score should be used in combination with the AAP-Score in the future to appraise the condition of premature infants. Its predictive value regarding the neonatal mortality of premature infants is very good. Detailed results will be published soon.

The present study analyzes the validity of the specified Apgar- and the AAP- Scores in asphyxiated infants >37 weeks of gestation undergoing resuscitation. Since the Apgar-score presents an index for the postnatal adaption to the extra-uterine life, reflects the efficiency of resuscitative interventions and also serves as an inclusion criteria for specific types of therapy (e.g. hypothermia therapy), it is necessary, to standardise the use of the Apgar-score and improve its prognostic value.

  Eligibility

Ages Eligible for Study:   37 Weeks and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Asphyxiated newborns >37 weeks of gestation receiving resuscitative interventions

Criteria

Inclusion Criteria:

  • Parental consent
  • Born within the study center (inborn)
  • gestational age >37 completed weeks
  • Receiving one or more resuscitive intervention (CPAP, Oxygen supplementation, Intubation and ventilation, bag and mask ventilation, surfactant, catecholamines, chest compression) and/or Birth Asphyxia with a umbilical artery pH <7,0 or BE > -16 with subsequent admission to NICU.

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: NCT01193751

Locations
Germany
Dresden University of Technology, Department of Neonatology Recruiting
Dresden, Germany, 01307
Contact: Mario Ruediger    0049351 458 ext 3640    mario.ruediger@uniklinikum-dresden.de   
Sponsors and Collaborators
Technische Universität Dresden
  More Information

No publications provided

Responsible Party: Prof. Dr. Mario Rüdiger, Dresden University of Technology, Department of Neonatology
ClinicalTrials.gov Identifier: NCT01193751     History of Changes
Other Study ID Numbers: Apgar in asphyxiated infants
Study First Received: September 1, 2010
Last Updated: February 17, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Technische Universität Dresden:
Birth Asphyxia
Newborn's Resuscitation
Death
Neurodevelopmental Impairment

Additional relevant MeSH terms:
Death
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014