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Status unknownNCT01193751Updated Feb 18, 2011

Apgar-Score in Asphyxiated Infants Under Resuscitation

An observational study in Death and Neurodevelopmental Impairment, sponsored by Technische Universität Dresden. Status unknown at 1 site in Germany. Open to participants aged 37 Weeks and older. Per ClinicalTrials.gov, last updated 2011-02-18.

Sponsored by Technische Universität Dresden · Observational

The sponsor has not verified this record recently (last verified Sep 2010), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
37 Weeks and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Death
  • Neurodevelopmental Impairment

Keywords

  • Birth Asphyxia
  • Newborn's Resuscitation
  • Death
  • Neurodevelopmental Impairment
03

In context

Death

583 studies on the registry are indexed under Death; 109 are open to participants now.

This study's planned enrollment of 200 is below the median of 300 across 297 observational studies indexed under Death.

Browse Death studies →

Lead sponsor

Technische Universität Dresden is the lead sponsor of 247 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
37 Weeks and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Asphyxiated newborns >37 weeks of gestation receiving resuscitative interventions

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

missing parental consent

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)

Groups and cohorts

  • asphyxiated newborns > 37 weeks of gestation
06

What researchers measure

Primary outcomes

  1. Death or Neurologic impairment

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01193751
First posted
Sep 2, 2010
Start date
Sep 2010
Primary completion
Dec 2011 (estimated)
Completion
Dec 2011 (estimated)
Last update
Feb 18, 2011

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.

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