Fidgety Movements of Preterm Neonates Included in COSGOD III (Figdety_Ms)

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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Estimated): 183

Contacts and Locations

• Study Contact: Name: Christina H. Wolfsberger, MD; Phone Number: 00436604422218; Email: christina.wolfsberger@medunigraz.at
• Study Contact Backup: Name: Gerhard Pichler, Prof; Email: gerhard.pichler@medunigraz.at

Study Locations

• Austria
  • Graz, Austria, 8036
    • Recruiting
    • Division of Neonatology, Department of Pediatrics and Adolescent Medicine, Medical University of Graz
    • Contact: Christina H. Wolfsberger, MD; Phone Number: 00436604422218; Email: christina.wolfsberger@medunigraz.at
    • Contact: Gerhard Pichler, Prof.; Email: gerhard.pichler@medunigraz.at
  • Innsbruck, Austria
    • Not yet recruiting
    • Medical University of Innsbruck
    • Contact: Ursula Kiechl-Kohlendorfer, Prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interventions during resuscitation	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.	First 15 minutes after birth
Interventions during the 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.	First 24 hours after birth
Neonatal morbidity at 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.	Between birth and term age

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Investigators: Principal Investigator: Gerhard Pichler, Prof., Division of Neonatology, Medical University of Graz, Austria

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): March 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: October 6, 2023
• First Submitted That Met QC Criteria: October 23, 2023
• First Posted (Actual): October 27, 2023

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: preterm birth; near-infrared spectroscopy; preterm neonates; cerebral oxygenation; resuscitation; neurological outcome; general movements; cerebral injury; fidgety movements
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: Figdety Movements - COSGOD III

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No