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

Medical University of Graz

Status: Enrolling

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

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

Study type: Observational

Funder types: Other

Identifiers

NCT06105333

Figdety Movements - COSGOD III

Details and patient eligibility

About

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.

Enrollment: 183 estimated patients

Sex: All

Ages: Under 40 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

183 participants in 2 patient groups

NIRS Group

Description:

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.

Treatment:

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

Standard Care Group

Description:

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.