General Movement AssessmentGMASafeboosCNCT04555915
General Movement Assessment - Ancillary Study to SafeBoosC III Trial
An observational study of General Movement Assessment, run by Medical University of Graz at 1 site in Austria.
Trial summary
In course of the SafeBoosC III trial, we would like to analyse routinely performed GMA as secondary outcome parameter in an ancillary observational study. First aim is to analyse in surviving neonates included into the SafeboosC III trial any differences between the experimental group group and control group in… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- General Movement Assessment
- What is being tested?
- Monitoring of cerebral oxygenation
- How many people
- 15 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jul 2020to 31 May 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Neonates will be included, in whom GM assessment is performed routinely at corrected term age or before discharge and optionally at a corrected age between 9 to 16 weeks.
Who may be able to join
- Signed informed consent
Who cannot join
- Missing written parental informed consent
- Decision not to conduct full life support
Trial locations and contacts
1 site in 1 country.
Austria1 site
Dep. of Pediatrics, Medical University of Graz
Graz, Styria, 8036
About this study
In course of the SafeBoosC III trial, we would like to analyse routinely performed GMA as secondary outcome parameter in an ancillary observational study.
First aim is to analyse in surviving neonates included into the SafeboosC III trial any differences between the experimental group group and control group in Global-GMA at term age.
Second aim is to investigate GMOS at term age and if available GMA at 9-16 weeks corrected age.
Read the detailed description
OBJECTIVE In course of the SafeBoosC III trial, we would like to analyse routinely performed GMA as as secondary outcome parameter in an ancillary observational study.
First aim is to analyse in surviving neonates included into the SafeboosC III trial any differences between the experimental group group and control group in Global-GMA at term age.
Second aim is to investigate GMOS at term age and if available GMA at 9-16 weeks corrected age.
HYPOTHESES We hypothesise that the surviving preterm neonates in the experimental group of the SafeBoosC III trial show better results in Global-GMA at term age compared to surviving neonates in the control group.
Furthermore, we hypothesise that the surviving preterm neonates in the experimental group of the SafeBoosC III trial show better results in GMOS at term age and in GMA if available at 9-16 weeks corrected age.
METHODS Trial design It will be a pilot observational ancillary study to the SafeBoosC III trial.
Eligibility Preterm neonates included in SafeBoosC III trial are eligible to be included in this ancillary study. Neonates will be included, in whom GM assessment is performed routinely at corrected term age or before discharge and optionally at a corrected age between 9 to 16 weeks. The infants are recorded according to routine after feeding, during periods of active wakefulness and lying in a supine position for 10-20 minutes. To evaluate the GMA visual Prechtl Gestalt perception are used. Because of the routine use in GMA, handling should reach the quality parameters, necessary for an optimal interpretation of these results.
Outcome measures Primary outcome measure for this ancillary observational study will be Global-GMA at term age Secondary outcome measure for this ancillary observational study will be GMOS at term age and if available GMA at a corrected age between 9 to 16 weeks.
Blinding Interpretation of Global-GMA and GMOS will be performed by analysing pseudo-anonymised video-recordings by persons trained in GMA and not involved in the care of the neonates.
GMA Data Global GMA will be classified as normal and abnormal (poor repertoire, chaotic, cramped synchronised at term age/absent fidgety movements at corrected age of 9-16 weeks). GMOS will be scored from zero to 42.
Data managing plan Demographic data will be handled according the data managing plan of the SafeboosC III protocol in its latest version.
GMA and GMOS data will be anonymised at each centre participating in this ancillary study with the local patient ID used in the SafeboosC III trial and handled according to local guidelines. Local statistical analyses will be performed in each participating centre in this ancillary study and just the results of these statistical analyses will be transferred to Medical University of Graz, Graz, Austria for overall/meta-analyses.
Statistical analyses Baseline characteristics of neonates will be given as mean and standard deviation or median and interquartile range for continuous data and as numbers and percentages for categorical data. Comparison of baseline characteristics will be done by using t-Test or Mann Whitney U-test for continuous data and Chi-square test or Fisher's exact test for categorical data. To answer the primary hypothesis whether global GMA differ between neonates of the control group and neonates of the intervention group OR will be calculated within each center. To analyze the secondary outcome measure GOMS a modified version of Agresti's (1980) generalized odds ratio (genOR), which accounts for ties, will be calculated within each center.
genOR=(Prob(Y_1<Y_2))/(Prob(Y_1>Y_2)) Since data are collected in the same study and therefore the study designs are the same, we assume the treatment effect to be the same and differences in the results between centers are due to a random error. As a consequence data will be combined using fixed effect models. Overall OR for the global GMA and the GOMS will be calculated and Forest plots drawn.
- Conditions
- General Movement Assessment
- Being tested
- Monitoring of cerebral oxygenation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring of cerebral oxygenationOther
Modify cardio-respiratory support to avoid cerebral hypoxia
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Intervention Group of the SafeboosC Phase III Trial Receives: Other: Monitoring of cerebral oxygenation | |
| Control group | Control Group of the SafeboosC Phase III Trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
GMA term age
General movement assessment
Measured: at term age (gestational age between 37+0 to 42+0 weeks)
Secondary outcomes (1)
GMA 6-9 weeks
General movement assessment 6-9 weeks
Measured: if available optionally at a corrected age between 9 to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start1 Jul 2020
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General Movement AssessmentStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Principal investigator, Pichler Gerhard, MD., Medical University of Graz
- Investigators
- Gerhard Pichler, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04555915
- Sponsor's protocol ID
- GMA Version 1.2
- Acronym
- GMASafeboosC
- Status last verified
- Jul 2022
- First submitted
- 1 Sep 2020
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- General Movement Assessment - Ancillary Study to SafeBoosC III Trial
- ClinicalTrials.gov ID
- NCT04555915
- Acronym / sponsor ID
- GMASafeboosC / GMA Version 1.2
- Conditions
- General Movement Assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 21 Sep 2020 (actual)
- 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.
In course of the SafeBoosC III trial, we would like to analyse routinely performed GMA as secondary outcome parameter in an ancillary observational study.
First aim is to analyse in surviving neonates included into the SafeboosC III trial any differences between the experimental group group and control group in Global-GMA at term age.
Second aim is to investigate GMOS at term age and if available GMA at 9-16 weeks corrected age.
Detailed description
OBJECTIVE In course of the SafeBoosC III trial, we would like to analyse routinely performed GMA as as secondary outcome parameter in an ancillary observational study.
First aim is to analyse in surviving neonates included into the SafeboosC III trial any differences between the experimental group group and control group in Global-GMA at term age.
Second aim is to investigate GMOS at term age and if available GMA at 9-16 weeks corrected age.
HYPOTHESES We hypothesise that the surviving preterm neonates in the experimental group of the SafeBoosC III trial show better results in Global-GMA at term age compared to surviving neonates in the control group.
Furthermore, we hypothesise that the surviving preterm neonates in the experimental group of the SafeBoosC III trial show better results in GMOS at term age and in GMA if available at 9-16 weeks corrected age.
METHODS Trial design It will be a pilot observational ancillary study to the SafeBoosC III trial.
Eligibility Preterm neonates included in SafeBoosC III trial are eligible to be included in this ancillary study. Neonates will be included, in whom GM assessment is performed routinely at corrected term age or before discharge and optionally at a corrected age between 9 to 16 weeks. The infants are recorded according to routine after feeding, during periods of active wakefulness and lying in a supine position for 10-20 minutes. To evaluate the GMA visual Prechtl Gestalt perception are used. Because of the routine use in GMA, handling should reach the quality parameters, necessary for an optimal interpretation of these results.
Outcome measures Primary outcome measure for this ancillary observational study will be Global-GMA at term age Secondary outcome measure for this ancillary observational study will be GMOS at term age and if available GMA at a corrected age between 9 to 16 weeks.
Blinding Interpretation of Global-GMA and GMOS will be performed by analysing pseudo-anonymised video-recordings by persons trained in GMA and not involved in the care of the neonates.
GMA Data Global GMA will be classified as normal and abnormal (poor repertoire, chaotic, cramped synchronised at term age/absent fidgety movements at corrected age of 9-16 weeks). GMOS will be scored from zero to 42.
Data managing plan Demographic data will be handled according the data managing plan of the SafeboosC III protocol in its latest version.
GMA and GMOS data will be anonymised at each centre participating in this ancillary study with the local patient ID used in the SafeboosC III trial and handled according to local guidelines. Local statistical analyses will be performed in each participating centre in this ancillary study and just the results of these statistical analyses will be transferred to Medical University of Graz, Graz, Austria for overall/meta-analyses.
Statistical analyses Baseline characteristics of neonates will be given as mean and standard deviation or median and interquartile range for continuous data and as numbers and percentages for categorical data. Comparison of baseline characteristics will be done by using t-Test or Mann Whitney U-test for continuous data and Chi-square test or Fisher's exact test for categorical data. To answer the primary hypothesis whether global GMA differ between neonates of the control group and neonates of the intervention group OR will be calculated within each center. To analyze the secondary outcome measure GOMS a modified version of Agresti's (1980) generalized odds ratio (genOR), which accounts for ties, will be calculated within each center.
genOR=(Prob(Y_1<Y_2))/(Prob(Y_1>Y_2)) Since data are collected in the same study and therefore the study designs are the same, we assume the treatment effect to be the same and differences in the results between centers are due to a random error. As a consequence data will be combined using fixed effect models. Overall OR for the global GMA and the GOMS will be calculated and Forest plots drawn.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | – | Other: Monitoring of cerebral oxygenationIntervention Group of the SafeboosC Phase III Trial |
| Control group | – | –Control Group of the SafeboosC Phase III Trial |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Neonates will be included, in whom GM assessment is performed routinely at corrected term age or before discharge and optionally at a corrected age between 9 to 16 weeks.
Key inclusion criteria (1 listed)
- Signed informed consent
Key exclusion criteria (2 listed)
- Missing written parental informed consent
- Decision not to conduct full life support
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monitoring of cerebral oxygenationModify cardio-respiratory support to avoid cerebral hypoxia | Other | Intervention group |
Primary outcome
GMA term age
Time frame: at term age (gestational age between 37+0 to 42+0 weeks)
General movement assessment
1 secondary outcome
GMA 6-9 weeks
Time frame: if available optionally at a corrected age between 9 to 16 weeks
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 13 Jul 2022.
- Individual participant dataSharing planned: Undecided
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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.
Gerhard Pichler, MD principal investigator
Medical University of Graz
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 General Movement Assessment, run by Medical University of Graz at 1 site in Austria.
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 1 inclusion and 2 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 13 Jul 2022. 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 Austria. 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?
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?
GMA term age (time frame: at term age (gestational age between 37+0 to 42+0 weeks)). 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 13 Jul 2022.