Cerebral Regional Tissue Oxygen Saturation to Guide Oxygen Delivery in Preterm Neonates During Immediate Transition

Brain Injuries Clinical Trial

— COSGOD  

Official title:

Cerebral Regional Tissue Oxygen Saturation to Guide Oxygen Delivery in Preterm Neonates During Immediate Transition After Birth: An Investigator-initiated Randomised Multi-centre Multinational Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03166722
• Other study ID #: COSGOD Phase III
• Status: Completed
• Phase: N/A
• Start date: September 20, 2017
• Est. completion date: February 10, 2022

Study information

• Verified date: February 2022
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

Background

The transition to life after birth is a complex physiological process where the neonate has to establish sufficient ventilation and changes from intra-uterine circulation to extra-uterine circulation take place. During these processes the neonate has to provide the brain with adequate perfusion and oxygen delivery to maintain normal cerebral tissue oxygenation and activity. If hypoxia and bradycardia both common events during immediate transition in preterm neonates occur, cerebral hypoxia-ischaemia may cause perinatal brain injury that is the major causes of mortality and long term neurodevelopmental impairment.

Objectives

The primary objective 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 (SpO2) and heart rate (HR) and specified clinical treatment guidelines during immediate transition period after birth (the first 15 minutes).

Hypothesis

The investigators hypothesise that using cerebral tissue oxygen saturation in addition to SpO2 and HR monitoring and specified treatment guidelines during immediate transition and resuscitation would increase survival without cerebral injury in preterm neonates.

Trial design

An investigator-initiated randomised, multi-centre, multinational, phase III clinical trial involving preterm infants from European countries and North America.

Inclusion and exclusion criteria

The inclusion criteria are: neonates born more than 8 weeks preterm (gestational age up to 31 weeks and 6 days); decision to conduct full life support; parental informed consent; and cerebral NIRS oximeter placed within three minutes after birth.

Sample size

According to actual data of two European centres (Graz and Rotterdam) and one Canadian centre (Edmonton) the percentage of neonates not affected by mortality and cerebral injury is 65%. Assuming an increase of not affected neonates from 65% to 75% and a dropout rate of 10% a total of 724 neonates are required to detect this difference with a two group χ² test (alpha: 0.05, power: 80%).

Intervention

The premature infants will be randomised into experimental or control group. Both groups will have a near infrared spectroscopy (NIRS) device (left frontal), pulse-oximeter (right wrist) and electrocardiogram placed within three minutes after birth. In the study group, the cerebral tissue saturation, SpO2 and HR readings are visible, and the infant will be treated accordingly using a defined treatment guideline. In the control group, only SpO2 and HR will be visible, and the infant will be treated according routine treatment.

Duration of intervention Monitoring will be started within 3 minutes after birth and the intervention will last during immediate transition period and resuscitation up to 15 minutes after birth.

Follow up

Thereafter, each neonate will be followed up for primary outcome to term date or discharge.

Outcome measures

The primary outcome is mortality and/or cerebral injury defined as any intraventricular bleeding and/or cystic periventricular leucomalacia.

The secondary outcomes are neonatal morbidities.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 655
• Est. completion date: February 10, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 15 Minutes

Eligibility

Inclusion Criteria:

• Preterm neonates less than completed 32 weeks,

• Decision to conduct full life support,

• Written informed consent.

Exclusion Criteria:

• No decision to conduct full life support,

• No written informed consent,

• Congenital malformation.

Related Conditions & MeSH terms

• Birth Hypoxia
• Brain Injuries
• Hypoxia
• Premature Birth
• Preterm Infant

Intervention

Other:
• Control group
SpO2 and HR monitoring and routine treatment during immediate transition

Device:
• Study group
Cerebral NIRS measurement with INVOS 5100 during immediate transition in addition to SpO2 and HR monitoring

Locations

Country	Name	City	State
Austria	Department of Pediatrics, Medical University of Graz	Graz	Styria
Austria	Medical University Innsbruck	Innsbruck
Austria	Medical University Vienna	Vienna
Canada	Royal Alexandra Hospital	Edmonton	Alberta
Germany	Universitätsklinikum Freiburg	Freiburg
Germany	Centre for Pediatric Clinical Studies	Tübingen
Ireland	University College Cork	Cork
Italy	Ospedale dei Bambini "V.Buzzi" Milano	Milano
Italy	Institute for Maternal and Child Health, IRCCS Burlo Garofolo	Trieste
Poland	Poznan University of Medical Sciences	Poznan
Poland	Uniwersytetu Medycznego im. Karola Marcinkowskiego	Poznan
Slovenia	University Medical Centre Ljubljana	Ljubljana

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Graz	Royal Alexandra Hospital

Countries where clinical trial is conducted

Austria,  Canada,  Germany,  Ireland,  Italy,  Poland,  Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Frequency of neonatal morbidities	Number of patients, who have infection and/or sepsis and/or necrotizing enterocolitis bronchoplumonary dysplasia, retinopathia prematurorumand/or bronchoplumonary dysplasia and /or retinopathia prematurorum	up to 19 weeks after birth
Secondary	Sex	Number of male and female patients, who die or have intraventricular hemorrhage or have periventricular leucomalacia	up to 19 weeks after birth
Secondary	Gestational age	Number of patients with less than 28 weeks of gestation and more than or equal 28 weeks of gestation, who die or have intraventricular hemorrhage or have periventricular leucomalacia	up to 19 weeks after birth