DeathNCT01193751
Apgar-Score in Asphyxiated Infants Under Resuscitation
An observational study of Death and Neurodevelopmental Impairment, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
The specified Apgar-Score in combination with the AAP-Score predicts the morbidity and mortality of asphyxiated newborns. Read more about this study
- Who is it for?
- Ages 37 weeks and older
- Conditions the study is for
- Death, Neurodevelopmental Impairment
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2010to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 37 weeks and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Asphyxiated newborns >37 weeks of gestation receiving resuscitative interventions
Who may be able to join
- 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.
Who cannot join
- missing parental consent
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Dresden University of Technology, Department of Neonatology
Dresden, 01307
Mario Ruediger, 0049351 458 ext. 3640, mario.ruediger@uniklinikum-dresden.de
About this study
Official title: Prospective Multicenter Study to Evaluate the Validity of the Specified Apgar-score in Asphyxiated Infants Under Resuscitation
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.
- Conditions
- Death, Neurodevelopmental Impairment
- Keywords
- Birth Asphyxia, Newborn's Resuscitation, Death, Neurodevelopmental Impairment
- Medical subject headings
- Death, Asphyxia Neonatorum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| asphyxiated newborns > 37 weeks of gestation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death or Neurologic impairment
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeathStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01193751
- Sponsor's protocol ID
- Apgar in asphyxiated infants
- Status last verified
- Sep 2010
- First submitted
- 1 Sep 2010
- Last updated
- 18 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Study to Evaluate the Validity of the Specified Apgar-score in Asphyxiated Infants Under Resuscitation
- ClinicalTrials.gov ID
- NCT01193751
- Acronym / sponsor ID
- Apgar in asphyxiated infants
- Conditions
- Death, Neurodevelopmental Impairment
- Keywords
- Birth Asphyxia, Newborn's Resuscitation, Death, Neurodevelopmental Impairment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 2 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The specified Apgar-Score in combination with the AAP-Score predicts the morbidity and mortality of asphyxiated newborns.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| asphyxiated newborns > 37 weeks of gestation | – | – |
Who may qualify
- Ages
- 37 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Asphyxiated newborns >37 weeks of gestation receiving resuscitative interventions
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- missing parental consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Death or Neurologic impairment
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dresden University of Technology, Department of Neonatology
Dresden, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Death and Neurodevelopmental Impairment, run by Technische Universität Dresden at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death or Neurologic impairment (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2011.