Does the Use of Higher Versus Lower Oxygen Concentration Improve Neurodevelopmental Outcomes at 18-24 Months in Very Low Birthweight Infants - The HiLo-Trial

Status: Recruiting
Location: See all (19) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Preterm birth, or birth before 37 weeks' gestation, is increasingly common, occurring in 8 percent of pregnancies in Canada. Preterm birth is associated with many health complications, particularly when the birth happens before 29 weeks' gestation. At this gestational age, the lungs are not fully developed and it is not uncommon for infants to have problems breathing at the time of birth. One complication that can arise is when an infant stops breathing and needs to be resuscitated. When preterm babies need to be resuscitated doctors must take special care because of the small infant size and the immaturity of the brain and lungs. Oxygen is used to resuscitate babies who need it, but unfortunately there is disagreement about the best oxygen concentration to use. Oxygen concentration is important because both too much and too little oxygen can cause brain injury. This research aims to fill this knowledge gap by participating in an international clinical trial to compare the effects of resuscitating babies less than 29 weeks' gestational age with either a low oxygen concentration or a high oxygen concentration. The oxygen concentrations have been selected using the best available knowledge. This will be a cluster randomized trial where each participating hospital will be randomized to either 30 or 60 percent oxygen for the recruitment of 30 infants, and afterwards randomized to the other group for the recruitment of another 30 infants. After the trial, the investigator will determine whether the babies resuscitated with low oxygen or those resuscitated with high oxygen have better survival and long-term health outcomes. This research fills a critical knowledge gap in the care of extremely preterm babies and will impact their survival both here in Canada and internationally.

Eligibility
Participation Requirements
Sex: All
Maximum Age: Newborn
Healthy Volunteers: f
View:

• Infants born at 23 0/7 weeks to 28 6/7 weeks' gestational age who will receive full resuscitation and are without major congenital abnormalities

Locations
Other Locations
Canada
Foothills Hospital
ACTIVE_NOT_RECRUITING
Calgary
Royal Alexandra Hospital
ACTIVE_NOT_RECRUITING
Edmonton
Newborn Health - IWK Health Centre
RECRUITING
Halifax
Neonatal Intensive Care Unit - Hamilton Health Sciences
RECRUITING
Hamilton
McGill Univeristy
RECRUITING
Montreal
CHEO
RECRUITING
Ottawa
Chu University Laval
RECRUITING
Québec
Janeway Children's Health and Rehabilitation Centre
RECRUITING
St. John's
Neonatal Intensive Care Unit - Mount Sinai Hospital
ACTIVE_NOT_RECRUITING
Toronto
Sunnybrook Health Sciences Centre
ACTIVE_NOT_RECRUITING
Toronto
BC Children
RECRUITING
Vancouver
Health Sciences
RECRUITING
Winnipeg
Ireland
University College Cork
RECRUITING
Cork
Spain
Hospital Germans Tries i Pujol
NOT_YET_RECRUITING
Barcelona
Hospital Universitario Dexeus
NOT_YET_RECRUITING
Barcelona
Hospital de la Arrixaca
NOT_YET_RECRUITING
El Palmar
Hospital Las Palmas
NOT_YET_RECRUITING
Las Palmas De Gran Canaria
Hospital de Asturias
NOT_YET_RECRUITING
Oviedo
Hospital Universitario Materno Infantil Miguel Servet
NOT_YET_RECRUITING
Zaragoza
Contact Information
Primary
Georg Schmolzer, MD, PhD
schmolze@ualberta.ca
7807354647
Backup
Barb Kamstra, RN
Barb Kamstra <Barbara.Kamstra@albertahealthservices.ca>
7807354647
Time Frame
Start Date: 2022-06-27
Estimated Completion Date: 2027-12-30
Participants
Target number of participants: 1200
Treatments
Active_comparator: 30% group
Infants in the 30% oxygen group will remain in 30% oxygen (O2) until 5 min of age. At 5 min of age, the clinical team will assess oxygen saturation (SpO2). If SpO2 is \<85%, O2 should be increased by 10-20% every 60 sec to achieve SpO2 of 85% or greater or a SpO2 of 90-95% at 10 min of age. If SpO2 are greater than 95% at or before 5 min of age, O2 should be decreased stepwise (every 60 sec) with an aim to maintain SpO2 of 85% or greater during 5-10 min of age or 90-95% at and beyond 10 min of age.~Intervention: Infants randomized to the 30% oxygen group will receive 30% oxygen at birth for the first 5 minutes. At 5 minutes oxygen can be adjusted as needed.
Experimental: 60% group
Infants in the 60% oxygen group will remain in 60% oxygen (O2) until 5 min of age. At 5 min of age, the clinical team will assess oxygen saturation (SpO2). If SpO2 is \<85%, O2 should be increased by 10-20% every 60 sec to achieve SpO2 of 85% or greater or a SpO2 of 90-95% at 10 min of age. If SpO2 are greater than 95% at or before 5 min of age, O2 should be decreased stepwise (every 60 sec) with an aim to maintain SpO2 of 85% or greater during 5-10 min of age or 90-95% at and beyond 10 min of age.~Intervention: Infants randomized to the 60% oxygen group will receive 60% oxygen at birth for the first 5 minutes. At 5 minutes oxygen can be adjusted as needed.
Related Therapeutic Areas
Sponsors
Collaborators: University College Cork, Université de Montréal, University of British Columbia, University of Calgary, Memorial University of Newfoundland, Dalhousie University, University of Ottawa, University of Manitoba, McGill University, University of Toronto, University of Sydney, University of Valencia, Laval University, McMaster University
Leads: University of Alberta

This content was sourced from clinicaltrials.gov