Observing fidgety movements in preterm neonates after discharge
Fidgety Movements of Preterm Neonates Included in COSGOD III - Ancillary Retrospective Observational Study to COSGOD III Trial
This study looks at how fidgety movements in preterm babies after they leave the hospital can help us understand their brain development when they receive special care and monitoring.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 183 (estimated) |
| Ages | N/A to 40 Weeks |
| Sex | All |
| Sponsor | Medical University of Graz Academic / other |
| Locations | 2 sites (Graz and 1 other locations) |
| Trial ID | NCT06105333 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the neurological outcomes of preterm neonates who were part of the COSGOD III trial, focusing on fidgety movements observed between six to 20 weeks post-term. The study will analyze the effects of standard care combined with cerebral oxygen saturation monitoring on these movements. By comparing the intervention group with the control group, the researchers hope to determine if monitoring leads to improved neurological outcomes. The study is conducted at two centers in Austria, Graz and Innsbruck.
Who should consider this trial
Good fit: Ideal candidates for this study are preterm neonates who were included in the COSGOD III trial and underwent fidgety movement analysis.
Not a fit: Patients who did not have fidgety movement analysis performed between six to 20 weeks post-term may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of neurological outcomes in preterm neonates, potentially leading to improved care practices.
How similar studies have performed: While this study builds on previous research, the specific approach of using cerebral NIRS monitoring in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Graz and 1 other locations
- Division of Neonatology, Department of Pediatrics and Adolescent Medicine, Medical University of Graz — Graz, Austria (Recruiting)
- Medical University of Innsbruck — Innsbruck, Austria (Not_yet_recruiting)
Study contacts
- Principal investigator: Gerhard Pichler, Prof. — Division of Neonatology, Medical University of Graz, Austria
- Study coordinator: Christina H. Wolfsberger, MD
- Email: christina.wolfsberger@medunigraz.at
- Phone: 00436604422218
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.