PretermFigdety_MsNCT06105333
Fidgety Movements of Preterm Neonates Included in COSGOD III
An observational study of Preterm and General Movements, run by Medical University of Graz at 2 sites in Austria.
Trial summary
The evidence on the effects of clinical care with cerebral NIRS (Near-infrared spectroscopy) monitoring on short term neurological outcome, displayed by fidgety movements between six to 20 weeks post term, are still uncertain. Read more about this study
- Who is it for?
- Ages Up to 40 weeks
- Conditions the study is for
- Preterm, General Movements, Fidgety Movements
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 183 participants
- Where
- 2 sitesAustria
- Study dates
- 1 Sep 2023to 1 May 2024
- 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 Up to 40 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Preterm neonates < 32 weeks of gestational age included in COSGOD III trial in Graz and Innsbruck are eligible to be included in this ancillary study.
Who may be able to join
- Preterm neonates included in the COSGOD III trial
- Death
- Routinely performed fidgety movement (FM) analysis between six to 20 weeks post term
Who cannot join
- Neonates without FM analysis between six to 20 weeks post term
Trial locations and contacts
2 sites in 1 country.
Gerhard Pichler, Prof contact
Austria2 sites, 2 recruiting
- Recruiting
Division of Neonatology, Department of Pediatrics and Adolescent Medicine, Medical University of Graz
Graz, 8036
Christina H. Wolfsberger, MD, 00436604422218, christina.wolfsberger@medunigraz.at
Gerhard Pichler, Prof., gerhard.pichler@medunigraz.at
- Not yet recruiting
Medical University of Innsbruck
Innsbruck
Ursula Kiechl-Kohlendorfer, Prof
About this study
Official title: Fidgety Movements of Preterm Neonates Included in COSGOD III - Ancillary Retrospective Observational Study to COSGOD III Trial
The evidence on the effects of clinical care with cerebral NIRS (Near-infrared spectroscopy) monitoring on short term neurological outcome, displayed by fidgety movements between six to 20 weeks post term, are still uncertain.
Two centers (Graz and Innsbruck), who participated in the COSGOD III trial, routinely performed GMA between 37+0 to 42+0 weeks of corrected age (writhing movements) and between six to 20 weeks post term (fidgety movements).
Read more
Aim of the present study is therefore to assess in neonates, who were included into the COSGOD III trial, in a retrospective observational study routinely performed fidgety movements between six to 20 weeks of corrected age after discharge.
The investigators hypothesise that the preterm neonates in the intervention group of the COSGOD III trial show better survival and short term neurological outcome, displayed by normal fidgety movements, compared to neonates in the control group.
- Conditions
- Preterm, General Movements, Fidgety Movements, Near Infrared Spectroscopy, Neurological Outcome
- Being tested
- standard care plus cerebral oxygen saturation monitoring with a dedicated treatment guideline
- Keywords
- near-infrared spectroscopy, preterm neonates, preterm birth, cerebral injury, cerebral oxygenation, resuscitation, neurological outcome, fidgety movements, general movements
- Medical subject headings
- Premature Birth, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard care plus cerebral oxygen saturation monitoring with a dedicated treatment guidelineProcedure or surgery
CrSO2 (Cerebral regional oxygen saturation) monitoring was visible to the clinical team with the same SpO2 target as in the control group. If SpO2 (oxygen saturation) remained between the 10th and 90th centiles and within local limits, and crSO2 was <10th centile according to published reference ranges, FiO2 (fraction of inspired oxygen) was increased by 10-20% every 60 seconds or respiratory support was started or increased. If crSO2 remained >10th centile for >60 seconds or if rSO2 was >90th centile,FiO2 was reduced by 10-20% or respiratory support was adjusted accordingly. If there was a history of blood loss or clinical signs of blood loss, intravenous fluids (10 mL/kg) were considered.
| Study group | Role | What they receive |
|---|---|---|
| NIRS Group | Preterm neonates less than 32 weeks gestation were randomly assigned to standard care plus cerebral oxygen saturation monitoring with a dedicated treatment guideline (NIRS-group) during immediate transition (first 15 minutes after birth) and resuscitation. Receives: Procedure: standard care plus cerebral oxygen saturation monitoring with a dedicated treatment guideline | |
| Standard Care Group | Preterm neonates less than 32 weeks gestation were randomly assigned to standard care (control-group) with routine monitoring during immediate transition (first 15 minutes after birth) and resuscitation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term outcome
Combined outcome of survival with normal Fidgety movement analysis. Outcome defined as good (survival with normal fidgety movements) or poor (death, abnormal/absent of fidgety movements). Mortality is assessed by medical documentation system.
Fidgety movement assessements were performed by video recording of sequences of at least three minutes. Fidgety movements were documented by clinical staff trained and certified for GMA. FMs were as either normal or abnormal, whereby abnormal FMs are further divided into two categories: absent or abnormal.
Measured: Between six to 20 weeks post term in surviving preterm neonates
Secondary outcomes (3)
Interventions during resuscitation
Interventions during the first 15 minutes after birth include n (%) of supplemental oxygen, respiratory support, chest compression, caffeine, adrenaline, surfactant, volume. These data were documented in the eCRF.
Measured: First 15 minutes after birth
Interventions during the first 24 hours after birth
Interventions during the first 24 hours after birth include n (%) of surfactant, no respiratory support, non-invasive ventilation and mechanical ventilation. These data were documented in the eCRF.
Measured: First 24 hours after birth
Neonatal morbidity at term age
Neonatal morbidities include n (%) of IVH (any grade), cystic PVL, IRDS, culture proven sepsis, NEC, BPD, ROP and PDA with interventions. These data were documented in the eCRF.
Measured: Between birth and term age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start1 Sep 2023
- Primary completion1 Mar 2024
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PretermStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 183 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gerhard Pichler, Prof., Principal investigator, Division of Neonatology, Medical University of Graz, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06105333
- Sponsor's protocol ID
- Figdety Movements - COSGOD III
- Acronym
- Figdety_Ms
- Status last verified
- Mar 2024
- First submitted
- 6 Oct 2023
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fidgety Movements of Preterm Neonates Included in COSGOD III - Ancillary Retrospective Observational Study to COSGOD III Trial
- ClinicalTrials.gov ID
- NCT06105333
- Acronym / sponsor ID
- Figdety_Ms / Figdety Movements - COSGOD III
- Conditions
- Preterm, General Movements, Fidgety Movements, Near Infrared Spectroscopy, Neurological Outcome
- Keywords
- near-infrared spectroscopy, preterm neonates, preterm birth, cerebral injury, cerebral oxygenation, resuscitation, neurological outcome, fidgety movements
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 183 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 27 Oct 2023 (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.
The evidence on the effects of clinical care with cerebral NIRS (Near-infrared spectroscopy) monitoring on short term neurological outcome, displayed by fidgety movements between six to 20 weeks post term, are still uncertain.
Two centers (Graz and Innsbruck), who participated in the COSGOD III trial, routinely performed GMA between 37+0 to 42+0 weeks of corrected age (writhing movements) and between six to 20 weeks post term (fidgety movements).
Aim of the present study is therefore to assess in neonates, who were included into the COSGOD III trial, in a retrospective observational study routinely performed fidgety movements between six to 20 weeks of corrected age after discharge.
The investigators hypothesise that the preterm neonates in the intervention group of the COSGOD III trial show better survival and short term neurological outcome, displayed by normal fidgety movements, compared to neonates in the control group.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NIRS Group | – | Procedure: standard care plus cerebral oxygen saturation monitoring with a dedicated treatment guidelinePreterm neonates less than 32 weeks gestation were randomly assigned to standard care plus cerebral oxygen saturation monitoring with a dedicated treatment guideline (NIRS-group) during immediate transition (first 15 minutes after birth) and resuscitation. |
| Standard Care Group | – | –Preterm neonates less than 32 weeks gestation were randomly assigned to standard care (control-group) with routine monitoring during immediate transition (first 15 minutes after birth) and resuscitation. |
Who may qualify
- Ages
- Up to 40 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm neonates < 32 weeks of gestational age included in COSGOD III trial in Graz and Innsbruck are eligible to be included in this ancillary study.
Key inclusion criteria (3 listed)
- Preterm neonates included in the COSGOD III trial
- Death
- Routinely performed fidgety movement (FM) analysis between six to 20 weeks post term
Key exclusion criteria (1 listed)
- Neonates without FM analysis between six to 20 weeks post term
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 |
|---|---|---|
| standard care plus cerebral oxygen saturation monitoring with a dedicated treatment guidelineCrSO2 (Cerebral regional oxygen saturation) monitoring was visible to the clinical team with the same SpO2 target as in the control group. If SpO2 (oxygen saturation) remained between the 10th and 90th centiles and within local limits, and crSO2 was <10th centile according to published reference ranges, FiO2 (fraction of inspired oxygen) was increased by 10-20% every 60 seconds or respiratory support was started or increased. If crSO2 remained >10th centile for >60 seconds or if rSO2 was >90th centile,FiO2 was reduced by 10-20% or respiratory support was adjusted accordingly. If there was a history of blood loss or clinical signs of blood loss, intravenous fluids (10 mL/kg) were considered. | Procedure or surgery | NIRS Group |
Primary outcome
Short-term outcome
Time frame: Between six to 20 weeks post term in surviving preterm neonates
Combined outcome of survival with normal Fidgety movement analysis. Outcome defined as good (survival with normal fidgety movements) or poor (death, abnormal/absent of fidgety movements). Mortality is assessed by medical documentation system. Fidgety movement assessements were performed by video recording of sequences of at least three minutes. Fidgety movements were documented by clinical staff trained and certified for GMA. FMs were as either normal or abnormal, whereby abnormal FMs are further divided into two categories: absent or abnormal.
3 secondary outcomes
Interventions during resuscitation
Time frame: First 15 minutes after birth
Interventions during the first 24 hours after birth
Time frame: First 24 hours after birth
Neonatal morbidity at term age
Time frame: Between birth and term age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Individual participant dataSharing planned: No
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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, Prof contact
Gerhard Pichler, Prof. principal investigator
Division of Neonatology, Medical University of Graz, Austria
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm and General Movements, run by Medical University of Graz at 2 sites 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 3 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 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christina H. Wolfsberger, MD (00436604422218, christina.wolfsberger@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-term outcome (time frame: Between six to 20 weeks post term in surviving preterm neonates). 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 Mar 2024.