NCT03166722

Brief Summary

The aim of the COSGOD Phase III trial is to examine, if it is possible to increase survival without cerebral injury in preterm neonates \<32 weeks of gestation by monitoring the cerebral tissue oxygen saturation in addition to routine monitoring of arterial oxygen saturation and heart rate and specified clinical treatment guidelines during immediate transition period after birth (the first 15 minutes).

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
655

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
7 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2017

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 25, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

September 20, 2017

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2022

Completed
Last Updated

February 11, 2022

Status Verified

February 1, 2022

Enrollment Period

4.4 years

First QC Date

May 3, 2017

Last Update Submit

February 10, 2022

Conditions

Preterm InfantBrain InjuriesBirth Hypoxia

Outcome Measures

Primary Outcomes (1)

  • Mortality and/or occurrence of cerebral injury

    Number of patients, who die or have intraventricular hemorrhage or have periventricular leucomalacia

    up to 19 weeks after birth

Secondary Outcomes (3)

  • Frequency of neonatal morbidities

    up to 19 weeks after birth

  • Sex

    up to 19 weeks after birth

  • Gestational age

    up to 19 weeks after birth

Study Arms (2)

Study group: Invos 5100

EXPERIMENTAL

Supplemental oxygen support and respiratory/circulatory support is guided by cerebral regional tissue oxygenation (crSO2) measured with near-infrared spectroscopy ("INVOS 5100" ), in addition to the SpO2/HR (oxygen saturation/heart rate) monitoring according to routine.

Device: Study group

Control group: Routine care

ACTIVE COMPARATOR

Supplemental oxygen support and respiratory/circulatory support is guided by SpO2/HR monitoring according to routine - The resuscitation team is blinded to the crSO2 monitoring.

Other: Control group

Interventions

Control groupOTHER

SpO2 and HR monitoring and routine treatment during immediate transition

Control group: Routine care
Study groupDEVICE

Cerebral NIRS measurement with INVOS 5100 during immediate transition in addition to SpO2 and HR monitoring

Study group: Invos 5100

Eligibility Criteria

Age1 Minute - 15 Minutes
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Preterm neonates less than completed 32 weeks,
  • Decision to conduct full life support,
  • Written informed consent.

You may not qualify if:

  • No decision to conduct full life support,
  • No written informed consent,
  • Congenital malformation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Department of Pediatrics, Medical University of Graz

Graz, Styria, 8036, Austria

Location

Medical University Innsbruck

Innsbruck, Austria

Location

Medical University Vienna

Vienna, Austria

Location

Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, Germany

Location

Centre for Pediatric Clinical Studies

Tübingen, Germany

Location

University College Cork

Cork, Ireland

Location

Ospedale dei Bambini "V.Buzzi" Milano

Milan, Italy

Location

Institute for Maternal and Child Health, IRCCS Burlo Garofolo

Trieste, Italy

Location

Poznan University of Medical Sciences

Poznan, Poland

Location

Uniwersytetu Medycznego im. Karola Marcinkowskiego

Poznan, Poland

Location

University Medical Centre Ljubljana

Ljubljana, Slovenia

Location

Related Publications (3)

  • Perme T, Kornhauser Cerar L, Schwaberger B, Urlesberger B, Wolfsberger CH, Baik N, Goeral K, Hammerl M, Dempsey EM, Springer L, Lista G, Szczapa T, Fuchs H, Karpinski L, Bua J, Avian A, Law BHY, Buchmayer J, Kiechl-Kohlendorfer U, Schwarz CE, Gruendler K, Stucchi I, Klebermass-Schrehof K, Schmolzer GM, Pichler G; COSGOD III study group. Effect of timing of umbilical cord clamping on cerebral regional tissue oxygenation: a secondary analysis of the COSGOD III trial. Arch Dis Child Fetal Neonatal Ed. 2025 Oct 17;110(6):610-615. doi: 10.1136/archdischild-2024-327946.

    PMID: 40306760DERIVED

  • Pichler G, Goeral K, Hammerl M, Perme T, Dempsey EM, Springer L, Lista G, Szczapa T, Fuchs H, Karpinski L, Bua J, Avian A, Law B, Urlesberger B, Buchmayer J, Kiechl-Kohlendorfer U, Kornhauser-Cerar L, Schwarz CE, Grundler K, Stucchi I, Schwaberger B, Klebermass-Schrehof K, Schmolzer GM; COSGOD III study group. Cerebral regional tissue Oxygen Saturation to Guide Oxygen Delivery in preterm neonates during immediate transition after birth (COSGOD III): multicentre randomised phase 3 clinical trial. BMJ. 2023 Jan 24;380:e072313. doi: 10.1136/bmj-2022-072313.

    PMID: 36693654DERIVED

  • Pichler G, Baumgartner S, Biermayr M, Dempsey E, Fuchs H, Goos TG, Lista G, Lorenz L, Karpinski L, Mitra S, Kornhauser-Cerar L, Avian A, Urlesberger B, Schmolzer GM. Cerebral regional tissue Oxygen Saturation to Guide Oxygen Delivery in preterm neonates during immediate transition after birth (COSGOD III): an investigator-initiated, randomized, multi-center, multi-national, clinical trial on additional cerebral tissue oxygen saturation monitoring combined with defined treatment guidelines versus standard monitoring and treatment as usual in premature infants during immediate transition: study protocol for a randomized controlled trial. Trials. 2019 Mar 20;20(1):178. doi: 10.1186/s13063-019-3258-y.

    PMID: 30894226DERIVED

MeSH Terms

Conditions

Premature BirthBrain Injuries

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Gerhard Pichler, MD

    Medical University of Graz, Austria

    PRINCIPAL INVESTIGATOR

  • Georg M Schmölzer, MD, PhD

    Royal Alexandra Hospital, Edmonton, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: investigator-initiated randomised multi-centre multinational clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2017

First Posted

May 25, 2017

Study Start

September 20, 2017

Primary Completion

January 31, 2022

Study Completion

February 10, 2022

Last Updated

February 11, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will share

The demographic data and data of primary and secondary outcome will be stored at and available form the Institut for Medical Informatics, Statistics und Documentation, Medical University of Graz, Austria

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
After publication of primary and secondary outcome
Access Criteria
On demand

Locations

IE(1)PL(2)AU(3)CA(1)SL(1)IT(2)DE(2)