Comparing 30% and 60% oxygen for resuscitating very low birthweight infants
Does the Use of Higher Versus Lower Oxygen Concentration Improve Neurodevelopmental Outcomes at 18-24 Months in Very Low Birthweight Infants - The HiLo-Trial
This study is testing whether giving very low birthweight infants 30% or 60% oxygen at birth helps them survive and develop better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1200 (estimated) |
| Ages | 0 Minutes to 10 Minutes |
| Sex | All |
| Sponsor | University of Alberta Academic / other |
| Locations | 21 sites (Calgary, Alberta and 20 other locations) |
| Trial ID | NCT03825835 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the optimal oxygen concentration for resuscitating very low birthweight infants born between 23 and 28 weeks of gestation. It aims to compare the effects of administering either 30% or 60% oxygen at birth on neurodevelopmental outcomes and mortality rates. The study addresses a critical knowledge gap in neonatal care, as current guidelines on oxygen use during resuscitation are inconsistent. By conducting a large, multi-centre international trial, the researchers hope to provide evidence-based recommendations for clinicians to improve care for these vulnerable infants.
Who should consider this trial
Good fit: Ideal candidates for this study are infants born at 23 to 28 weeks of gestation who require full resuscitation and do not have major congenital abnormalities.
Not a fit: Patients who may not benefit from this study include those who are outborn, have major congenital abnormalities, or will not receive full resuscitation at birth.
Why it matters
Potential benefit: If successful, this study could lead to improved neurodevelopmental outcomes and reduced mortality rates for very low birthweight infants.
How similar studies have performed: Other studies have highlighted the need for better guidelines in oxygen resuscitation for preterm infants, indicating that this research addresses an important and previously underexplored area.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Calgary, Alberta and 20 other locations
- Foothills Hospital — Calgary, Alberta, Canada (Active_not_recruiting)
- Royal Alexandra Hospital — Edmonton, Alberta, Canada (Recruiting)
- BC Children — Vancouver, British Colubia, Canada (Recruiting)
- Health Sciences — Winnipeg, Manitoba, Canada (Recruiting)
- Janeway Children's Health and Rehabilitation Centre — St. John's, Newfoundland and Labrador, Canada (Active_not_recruiting)
- Newborn Health - IWK Health Centre — Halifax, Nova Scotia, Canada (Active_not_recruiting)
- Neonatal Intensive Care Unit - Hamilton Health Sciences — Hamilton, Ontario, Canada (Active_not_recruiting)
- Queen's University — Kingston, Ontario, Canada (Not_yet_recruiting)
- Cheo — Ottawa, Ontario, Canada (Recruiting)
- Neonatal Intensive Care Unit - Mount Sinai Hospital — Toronto, Ontario, Canada (Active_not_recruiting)
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (Active_not_recruiting)
- McGill Univeristy — Montreal, Quebec, Canada (Active_not_recruiting)
- Chu University Laval — Québec, Quebec, Canada (Recruiting)
- Université de Sherbrooke — Sherbrooke, Quebec, Canada (Not_yet_recruiting)
- University College Cork — Cork, Ireland (Recruiting)
- Hospital Germans Tries i Pujol — Barcelona, Spain (Withdrawn)
- Hospital Universitario Dexeus — Barcelona, Spain (Withdrawn)
- Hospital de la Arrixaca — El Palmar, Spain (Withdrawn)
- Hospital Las Palmas — Las Palmas de Gran Canaria, Spain (Withdrawn)
- Hospital de Asturias — Oviedo, Spain (Withdrawn)
- Hospital Universitario Materno Infantil Miguel Servet — Zaragoza, Spain (Withdrawn)
Study contacts
- Principal investigator: Georg Schmolzer, MD, PhD — University of Alberta
- Study coordinator: Georg Schmolzer, MD, PhD
- Email: schmolze@ualberta.ca
- Phone: 7807354647
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.