Fidgety Movements of Preterm Neonates Included in COSGOD III

NCT06105333 | Recruiting

• 1 other identifier: Figdety Movements - COSGOD III
• Study Type: observational
• Target: 183
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

near-infrared spectroscopy; preterm neonates; preterm birth; cerebral injury; cerebral oxygenation; resuscitation; neurological outcome; fidgety movements; general movements

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Interventions during resuscitation

  First 15 minutes after birth

• Interventions during the first 24 hours after birth

  First 24 hours after birth

• Neonatal morbidity at term age

  Between birth and term age

Study Arms (2)

NIRS Group

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.

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

Standard Care Group

Preterm neonates less than 32 weeks gestation were randomly assigned to standard care (control-group) with routine monitoring during immediate transition (first 15 minutes after birth) and resuscitation.

Interventions

standard care plus cerebral oxygen saturation monitoring with a dedicated treatment guideline PROCEDURE

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.

NIRS Group

Eligibility Criteria

• Age: Up to 40 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Preterm neonates \< 32 weeks of gestational age included in COSGOD III trial in Graz and Innsbruck are eligible to be included in this ancillary study.

You may qualify if:

• Preterm neonates included in the COSGOD III trial
• Death
• Routinely performed fidgety movement (FM) analysis between six to 20 weeks post term

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (2)

Division of Neonatology, Department of Pediatrics and Adolescent Medicine, Medical University of Graz

Graz, 8036, Austria

RECRUITING

Medical University of Innsbruck

Innsbruck, Austria

NOT YET RECRUITING

MeSH Terms

Conditions

Premature Birth; Brain Injuries

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Gerhard Pichler, Prof.

  Division of Neonatology, Medical University of Graz, Austria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina H. Wolfsberger, MD

CONTACT

00436604422218; christina.wolfsberger@medunigraz.at

Gerhard Pichler, Prof

CONTACT

gerhard.pichler@medunigraz.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: October 27, 2023
• Study Start: September 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: May 1, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)