Fidgety Movements of Preterm Neonates Included in COSGOD III

Recruiting

• Conditions: General Movements; Fidgety Movements; Preterm; Near Infrared Spectroscopy; Neurological Outcome
• Interventions: Procedure: standard care plus cerebral oxygen saturation monitoring with a dedicated treatment guideline

• Registration Number: NCT06105333
• Lead Sponsor: Medical University of Graz

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-01
• Study First Submitted: 2023-10-06
• Study First Submitted QC: 2023-10-23
• Study First Posted: 2023-10-27
• Status Verified: 2024-03
• Primary Completion: 2024-03-01
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-13
• Study Completion: 2024-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 183

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NIRS Group	standard care plus cerebral oxygen saturation monitoring with a dedicated treatment guideline	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.

Primary Outcome Measures

Name	Time	Method
Short-term outcome	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.

Secondary Outcome Measures

Name	Time	Method
Interventions during resuscitation	First 15 minutes after birth	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.
Interventions during the first 24 hours after birth	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.
Neonatal morbidity at term age	Between birth and 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.

Trial Locations

Locations (2)

Division of Neonatology, Department of Pediatrics and Adolescent Medicine, Medical University of Graz; 🇦🇹 Graz, Austria

Medical University of Innsbruck; 🇦🇹 Innsbruck, Austria