2 Year Follow up of COSGOD III (COSGODIII-FU)

Medical University of Graz

Status: Completed

Conditions: Death; Neurodevelopmental Disability

Treatments: Other: NIRS group

Study type: Observational

Funder types: Other

Identifiers

NCT06141733

36-041 ex 23/24

Details and patient eligibility

About

The COSGOD III trial performed follow up until term age or discharge from the neonatal intensive care unit, whatever came first. The first neonate was randomised in September 2017 and the last in October 2021. A prospective follow up of the included neonates until an age of two years was not feasible in the COSGOD III trial since funding for long-term follow-up was not available.

However, data on long-term outcome of the included neonates into COSGOD III trial are of high interest. In many centres, who participated in the COSGOD III trial neonates are assessed routinely for long term outcome in outpatient clinics with Bayleys III/IV test or PARCA-R (Parent Report of Children's Abilities) questionnaire.

Aim of the present study is therefore to analyse in neonates, who were included into the COSGOD III trial, in a retrospective observational study routinely performed long-term survival and neurodevelopmental outcome assessment at a corrected age of 2 years (18-30 months).

Enrollment: 417 patients

Sex: All

Ages: 18 to 30 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• > 50% 2 year neurodevelopmental outcome assessment at 2 years (18 to 30 months)

Exclusion criteria

• < 50% 2 year neurodevelopmental outcome assessment at 2 years (18 to 30 months)

Trial design

417 participants in 2 patient groups

NIRS (Near-infrared spectroscopy) group of the COSGOD III trial

Description:

A multi-center, multi-national randomized-controlled trial was performed in 11 centers in Europe and Canada. 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. In the NIRS-group 252 (82.9%) out of 303 neonates (gestational-age, median (interquartile-range): 28.9 (26.9-30.6) weeks) survived without cerebral injury until term age or discharge. (primary outcome of the COSGOD III trial)

Treatment:

Other: NIRS group

Control group of the COSGOD III trial

Description:

A multi-center, multi-national randomized-controlled trial was performed in 11 centers in Europe and Canada. Preterm neonates less than 32 weeks gestation were randomly assigned to standard care (control-group) during immediate transition (first 15 minutes after birth) and resuscitation. In the Control-group 238 (78.5%) out of 304 neonates (gestational-age, median (interquartile-range): 28.6 (26.6-30.6) weeks) survived without cerebral injury until term age or discharge. (primary outcome of the COSGOD III trial)