Premature Infant Clinical Trial
— HiLoOfficial title:
Does the Use of Higher Versus Lower Oxygen Concentration Improve Neurodevelopmental Outcomes at 18-24 Months in Very Low Birthweight Infants - The HiLo-Trial
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.
Status | Recruiting |
Enrollment | 1200 |
Est. completion date | December 30, 2027 |
Est. primary completion date | September 30, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 0 Minutes to 10 Minutes |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - Infants who are outborn - initial resuscitation not performed at the study centre - Infants who are not born within the eligible gestational age range- this trial is specific to preterm infants - Infants who are born with a major congenital abnormality- congenital abnormalities may affect oxygenation or neurodevelopmental outcomes - Infants who will not receive full resuscitation at birth- these infants will not receive resuscitation |
Country | Name | City | State |
---|---|---|---|
Canada | Foothills Hospital | Calgary | Alberta |
Canada | Royal Alexandra Hospital | Edmonton | Alberta |
Canada | Newborn Health - IWK Health Centre | Halifax | Nova Scotia |
Canada | Neonatal Intensive Care Unit - Hamilton Health Sciences | Hamilton | Ontario |
Canada | McGill Univeristy | Montréal | Quebec |
Canada | CHEO | Ottawa | Ontario |
Canada | Chu University Laval | Québec | Quebec |
Canada | Janeway Children's Health and Rehabilitation Centre | Saint John's | Newfoundland and Labrador |
Canada | Neonatal Intensive Care Unit - Mount Sinai Hospital | Toronto | Ontario |
Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
Canada | BC Children | Vancouver | British Colubia |
Canada | Health Sciences | Winnipeg | Manitoba |
Ireland | University College Cork | Cork | |
Spain | Hospital Germans Tries i Pujol | Barcelona | |
Spain | Hospital Universitario Dexeus | Barcelona | |
Spain | Hospital de la Arrixaca | El Palmar | |
Spain | Hospital Las Palmas | Las Palmas De Gran Canaria | |
Spain | Hospital de Asturias | Oviedo | |
Spain | Hospital Universitario Materno Infantil Miguel Servet | Zaragoza |
Lead Sponsor | Collaborator |
---|---|
University of Alberta | Dalhousie University, Laval University, McGill University, McMaster University, Memorial University of Newfoundland, Université de Montréal, University College Cork, University of British Columbia, University of Calgary, University of Manitoba, University of Ottawa, University of Sydney, University of Toronto, University of Valencia |
Canada, Ireland, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Neurodevelopmental outcome at 18-24 months | At 18-24 months corrected age, the infants will be assessed using the Bayley Scales of Infant Development-3rd edition (Bayley-III). A score 85-114 will be classified as normal, and scores <70 (2 SD below the mean of 100) will define severe cognitive delay. | 18-24 months of age | |
Primary | Healing loss | Audiometry will be performed to assess the presence or absence of severe hearing loss. | 18-24 months of age | |
Primary | Blindness | Blindness will be defined as a corrected visual acuity of <20/200. | 18-24 months of age | |
Secondary | Number of intubation in the delivery room | Number of infants intubated in the delivery room | first 15 minutes after birth | |
Secondary | Death in the Neonatal Intensive Care Unit | Number of infants died after admission in the Neonatal Intensive Care Unit | During admission in the Neonatal Intensive Care Unit; no exact time frame can be given as this can happen after 1 day, 1 week, 1 months or up to 2-3 month. again deepening on gestational age and policy for transferring infants at participating centres. | |
Secondary | Death in the delivery room | Number of infants died in the delivery room during resuscitation | During resuscitation in the delivery room; for lay people: this time frame might be 10min or 1-3 hours, depending on the approaching each participating hospital |
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