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Fidgety Movements of Preterm Neonates Included in COSGOD III

NCT06105333 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 183

Last updated 2024-03-13

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Medical University of Graz

    lead OTHER

Principal Investigators

  • Gerhard Pichler, Prof. · Division of Neonatology, Medical University of Graz, Austria

Eligibility

Max Age
40 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2024-03-01
Completion
2024-05-01

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06105333 on ClinicalTrials.gov