NCT06105333

Fidgety Movements of Preterm Neonates Included in COSGOD III

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 183 (estimated)
• Sponsor: Medical University of Graz · Academic / Other
• Sex: All
• Age: 40 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Preterm
• General Movements
• Fidgety Movements
• Near Infrared Spectroscopy
• Neurological Outcome

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-09-01
• Primary completion: 2024-03-01
• Completion: 2024-05-01
• First posted: 2023-10-27
• Last updated: 2024-03-13

Locations

2 sites across 1 country: Austria