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Search / Trial NCT03825835

30% or 60% Oxygen at Birth to Improve Neurodevelopmental Outcomes in Very Low Birthweight Infants

Launched by UNIVERSITY OF ALBERTA · Jan 30, 2019

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Delivery Room Resuscitation Premature Infant Oxygen

ClinConnect Summary

This clinical trial is studying how different amounts of oxygen given at birth can affect the health and development of very premature infants, specifically those born between 23 and 28 weeks of pregnancy. When these tiny babies are born, their lungs are often not fully developed, and they may need help breathing. The trial will compare two levels of oxygen: 30% and 60%, to see which one helps improve their chances of survival and long-term health. This is important because using the right amount of oxygen is crucial—too much or too little can both cause problems for the baby's brain.

To be eligible for the trial, infants must be born within the specified gestational age and require full resuscitation at birth, meaning they need help breathing. Babies born with major birth defects that could affect their breathing or development will not be included. If your baby qualifies and participates in the study, they will be treated at a participating hospital, and doctors will carefully monitor their health outcomes over time. This research aims to improve care for extremely premature babies, which could lead to better survival and health outcomes for these vulnerable infants, both in Canada and around the world.

Gender

ALL

Eligibility 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

About University Of Alberta

The University of Alberta, a leading research institution in Canada, is dedicated to advancing healthcare through innovative clinical trials. With a strong commitment to scientific excellence and community health, the university facilitates cutting-edge research across various medical disciplines. Its interdisciplinary approach fosters collaboration among researchers, clinicians, and students, ensuring that clinical trials are designed and conducted with the utmost rigor and ethical standards. By leveraging its extensive resources and expertise, the University of Alberta aims to translate research findings into meaningful advancements in patient care and public health.

Locations

Calgary, Alberta, Canada

Edmonton, Alberta, Canada

Toronto, Ontario, Canada

Saint John's, Newfoundland And Labrador, Canada

Cork, , Ireland

Halifax, Nova Scotia, Canada

Hamilton, Ontario, Canada

Toronto, Ontario, Canada

Winnipeg, Manitoba, Canada

Montréal, Quebec, Canada

Vancouver, British Colubia, Canada

Ottawa, Ontario, Canada

Québec, Quebec, Canada

Barcelona, , Spain

Barcelona, , Spain

El Palmar, , Spain

Las Palmas De Gran Canaria, , Spain

Oviedo, , Spain

Zaragoza, , Spain

Patients applied

0 patients applied

Trial Officials

Georg Schmolzer, MD, PhD

Principal Investigator

University of Alberta

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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