Fidgety Movements of Preterm Neonates Included in COSGOD III

Preterm Clinical Trial

— Figdety_Ms  

Official title:

Fidgety Movements of Preterm Neonates Included in COSGOD III - Ancillary Retrospective Observational Study to COSGOD III Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06105333
• Other study ID #: Figdety Movements - COSGOD III
• Status: Recruiting
• Start date: September 1, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: March 2024
• Source: Medical University of Graz
• Contact: Christina H. Wolfsberger, MD
• Phone: 00436604422218
• Email: christina.wolfsberger[@]medunigraz.at
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 183
• Est. completion date: May 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 40 Weeks

Eligibility

Inclusion Criteria:

• Preterm neonates included in the COSGOD III trial

• Death

• Routinely performed fidgety movement (FM) analysis between six to 20 weeks post term

Exclusion Criteria:

• Neonates without FM analysis between six to 20 weeks post term

Related Conditions & MeSH terms

• Near Infrared Spectroscopy
• Neurological Outcome
• Premature Birth
• Preterm

Intervention

Procedure:
• standard care plus cerebral oxygen saturation monitoring with a dedicated treatment guideline
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.

Locations

Country	Name	City	State
Austria	Division of Neonatology, Department of Pediatrics and Adolescent Medicine, Medical University of Graz	Graz
Austria	Medical University of Innsbruck	Innsbruck

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Between six to 20 weeks post term in surviving preterm neonates
Secondary	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.	First 15 minutes after birth
Secondary	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.	First 24 hours after birth
Secondary	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.	Between birth and term age