Postnatal Condition of a Newborn InfantTEST-APGARNCT00623038
Trial to Evaluate a Specified Type of APGAR
An observational study of Postnatal Condition of a Newborn Infant, run by Technische Universität Dresden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 minute to 10 minutes
- Conditions the study is for
- Postnatal Condition of a Newborn Infant
- How many people
- 1,855 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to Jun 2009
- 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 1 minute to 10 minutes
- All sexes
- No healthy volunteers
- Child
Study population: Very preterm infants born prior to 32 completed weeks of gestation
Who may be able to join
- gestational age below 32 weeks
- born within the study centres
Who cannot join
- missing informed consent
- outborn
- major congenital abnormalities
- death in the delivery room
About this study
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 preterm infants and resuscitated newborns. Thus, two scores have been suggested recently - the Specified Apgar and the Expanded-Apgar score. By combining both scores the Combined-Apgar has been developed as a new delivery room tool.
The purpose of this study is to determine whether the Combined-Apgar predicts poor outcome better than the Specified- or Expanded Apgar alone.
Read the detailed description
Since the conventional Apgar score has its limitations in preterm or resuscitated infants, specifications of the individual items of the original Apgar score were suggested (Specified Apgar). The Specified-Apgar will slightly change the Apgars' perspective, but will not alter the number of its components. The advantage of the proposed definitions is the applicability in all infants, regardless of resuscitative efforts or gestational age. However, neither the conventional nor the Specified-Apgar score describes the condition of the infant. That problem has been taken up by the American Academy of pediatrics (AAP)and the American College of Obstetricians and Gynecologists (ACOG). They suggested to use an expanded Apgar Score reporting form (Expanded-Apgar)that accounts for concurrent resuscitative interventions. Whereas the Specified-Apgar score describes the condition of the infant, the Expanded-Apgar is a measure of interventions needed to achieve this condition. By combining both scores (Combined-Apgar) the postnatal condition is described in more detail than by a single score alone.
To validate the accuracy of these scores in a population of very preterm infants, the present prospective, observational, international multicenter study is planned. Until today there is no gold standard available to describe infant's conditions and interventions. For the evaluation of the scores it was therefore hypothesized that the Combined Apgar predicts poor outcome (defined as either death or any major morbidity) better than the Specified Apgar or Expanded Apgar alone. Prediction of poor outcome was used as a surrogate parameter to test the predictive value of the Combined-Apgar score in a clinical setting for preterm infants. In an attempt to determine how strong of an association there is between the Combined Apgar Score and neurologic impairment in early childhood, we are presently engaged in a long-term follow-up of all surviving infants at a corrected age of 24 months.
- Conditions
- Postnatal Condition of a Newborn Infant
- Keywords
- Apgar score, neonatal assessment, preterm infants, resuscitation
What is being measured
The primary outcome is the main question the study is designed to answer.
Poor outcome
Poor outcome is defined as death or the presence of either of the major morbidities: bronchopulmonary dysplasia (BPD), intraventricular hemorrhage (IVH) grade 1-4, cystic periventricular leucomalcia (CPL), retinopathy of prematurity (ROP)
Measured: Between birth and the day of discharge from first stay in hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2008 (estimated)
- Study startMar 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postnatal Condition of a Newborn InfantStudies 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
- 1,855 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Investigators
- Mario Ruediger, Principal investigator, Department of Neonatology and Pediatric Intensive Care, University Hospital Carl Gustav Carus Dresden, GermanyHelmut Kuester, Principal investigator, Department of Neonatology and Pediatric Intensiv Care, Ernst-Moritz-Arndt-University Greifswald, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00623038
- Sponsor's protocol ID
- TEST-APGAR
- Acronym
- TEST-APGAR
- Status last verified
- Apr 2011
- First submitted
- 14 Feb 2008
- Last updated
- 22 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Mense L, Nogel S, Kaufmann M, Kuster H, Braun N, Simma B, Rudiger M. Assessing the postnatal condition: the predictive value of single items of the Apgar score. BMC Pediatr. 2025 Mar 19;25(1):214. doi: 10.1186/s12887-025-05565-0.
PubMed 40102790Rudiger M, Braun N, Aranda J, Aguar M, Bergert R, Bystricka A, Dimitriou G, El-Atawi K, Ifflaender S, Jung P, Matasova K, Ojinaga V, Petruskeviciene Z, Roll C, Schwindt J, Simma B, Staal N, Valencia G, Vasconcellos MG, Veinla M, Vento M, Weber B, Wendt A, Yigit S, Zotter H, Kuster H; TEST-Apgar Study-Group. Neonatal assessment in the delivery room--Trial to Evaluate a Specified Type of Apgar (TEST-Apgar). BMC Pediatr. 2015 Mar 8;15:18. doi: 10.1186/s12887-015-0334-7.
PubMed 25884954
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial to Evaluate a Specified Type of APGAR
- ClinicalTrials.gov ID
- NCT00623038
- Acronym / sponsor ID
- TEST-APGAR / TEST-APGAR
- Conditions
- Postnatal Condition of a Newborn Infant
- Keywords
- Apgar score, neonatal assessment, preterm infants, resuscitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,855 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 25 Feb 2008 (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.
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 preterm infants and resuscitated newborns. Thus, two scores have been suggested recently - the Specified Apgar and the Expanded-Apgar score. By combining both scores the Combined-Apgar has been developed as a new delivery room tool.
The purpose of this study is to determine whether the Combined-Apgar predicts poor outcome better than the Specified- or Expanded Apgar alone.
Detailed description
Since the conventional Apgar score has its limitations in preterm or resuscitated infants, specifications of the individual items of the original Apgar score were suggested (Specified Apgar). The Specified-Apgar will slightly change the Apgars' perspective, but will not alter the number of its components. The advantage of the proposed definitions is the applicability in all infants, regardless of resuscitative efforts or gestational age. However, neither the conventional nor the Specified-Apgar score describes the condition of the infant. That problem has been taken up by the American Academy of pediatrics (AAP)and the American College of Obstetricians and Gynecologists (ACOG). They suggested to use an expanded Apgar Score reporting form (Expanded-Apgar)that accounts for concurrent resuscitative interventions. Whereas the Specified-Apgar score describes the condition of the infant, the Expanded-Apgar is a measure of interventions needed to achieve this condition. By combining both scores (Combined-Apgar) the postnatal condition is described in more detail than by a single score alone.
To validate the accuracy of these scores in a population of very preterm infants, the present prospective, observational, international multicenter study is planned. Until today there is no gold standard available to describe infant's conditions and interventions. For the evaluation of the scores it was therefore hypothesized that the Combined Apgar predicts poor outcome (defined as either death or any major morbidity) better than the Specified Apgar or Expanded Apgar alone. Prediction of poor outcome was used as a surrogate parameter to test the predictive value of the Combined-Apgar score in a clinical setting for preterm infants. In an attempt to determine how strong of an association there is between the Combined Apgar Score and neurologic impairment in early childhood, we are presently engaged in a long-term follow-up of all surviving infants at a corrected age of 24 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 minute to 10 minutes
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Very preterm infants born prior to 32 completed weeks of gestation
Key inclusion criteria (2 listed)
- gestational age below 32 weeks
- born within the study centres
Key exclusion criteria (4 listed)
- missing informed consent
- outborn
- major congenital abnormalities
- death in the delivery room
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
Poor outcome
Time frame: Between birth and the day of discharge from first stay in hospital
Poor outcome is defined as death or the presence of either of the major morbidities: bronchopulmonary dysplasia (BPD), intraventricular hemorrhage (IVH) grade 1-4, cystic periventricular leucomalcia (CPL), retinopathy of prematurity (ROP)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2011.
- Derived from this study: PubMed 40102790Mense L, Nogel S, Kaufmann M, Kuster H, Braun N, Simma B, Rudiger M. Assessing the postnatal condition: the predictive value of single items of the Apgar score. BMC Pediatr. 2025 Mar 19;25(1):214. doi: 10.1186/s12887-025-05565-0.
- Derived from this study: PubMed 25884954Rudiger M, Braun N, Aranda J, Aguar M, Bergert R, Bystricka A, Dimitriou G, El-Atawi K, Ifflaender S, Jung P, Matasova K, Ojinaga V, Petruskeviciene Z, Roll C, Schwindt J, Simma B, Staal N, Valencia G, Vasconcellos MG, Veinla M, Vento M, Weber B, Wendt A, Yigit S, Zotter H, Kuster H; TEST-Apgar Study-Group. Neonatal assessment in the delivery room--Trial to Evaluate a Specified Type of Apgar (TEST-Apgar). BMC Pediatr. 2015 Mar 8;15:18. doi: 10.1186/s12887-015-0334-7.
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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.
Mario Ruediger principal investigator
Department of Neonatology and Pediatric Intensive Care, University Hospital Carl Gustav Carus Dresden, Germany
Helmut Kuester principal investigator
Department of Neonatology and Pediatric Intensiv Care, Ernst-Moritz-Arndt-University Greifswald, Germany
Questions about this trial
What is this clinical trial studying?
An observational study of Postnatal Condition of a Newborn Infant, run by Technische Universität Dresden.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 22 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Poor outcome (time frame: Between birth and the day of discharge from first stay in hospital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00623038, which also lists 2 linked publications.
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 22 Apr 2011.