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

Study acronym: HiLo
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later across 2 updates Sep 30, 2027 → Sep 30, 2028
See other at-risk trials from University of Alberta

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion moved earlier from Sep 30, 2029 to Sep 30, 2028 Show 8 more changesShow less
    • Enrollment closed, study ongoing
    • Trial sites reduced: 21 → 14 locations
    • Enrollment target: 1200 to 1203
    • Secondary endpoints: details revised at 8 of 19 entries
    • Study description revised
    • Collaborators: details revised at 1 of 15 entries
    • Publications: details revised at 1 of 1 entry
    • Eligibility criteria expanded, about 5 words
  2. Primary completion pushed from Sep 30, 2027 to Sep 30, 2029
    • Site details revised at 4 of 21 sites
    v23
  3. Site details revised at 4 of 21 sitesv22
  4. Re-verified, no change to tracked fieldsv21
  5. Primary endpoints: 4 to 1
    • Secondary endpoints: 3 to 19
    v20
Show 18 earlier versionsHide 18 earlier versions
  1. Study sites: 19 to 21
    • Collaborators: 13 to 15
    v19
  2. Study completion date: Dec 30, 2027 to Dec 30, 2029
    • Site details revised at 11 of 19 sites
    • Collaborators: 14 to 13
    v18
  3. Primary endpoints revised (4)v17
  4. Primary endpoints: 3 to 4
    • Site details revised at 4 of 19 sites
    • Study description expanded, about 1 word
    v16
  5. Study sites: 9 to 19
    • Collaborators: 13 to 14
    v15
  6. Study sites: 8 to 9
    • Collaborators: 7 to 13
    v14
  7. Re-verified, no change to tracked fieldsv13
  8. Study sites: 6 to 8v12
  9. Study sites: 3 to 6v11
  10. Study sites: 1 to 3v10
  11. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 20, 2022 to Jun 27, 2022
    • Site details revised
    • Collaborators: 3 to 7
    v9
  12. Start date: May 1, 2022 to Jun 20, 2022v8
  13. Start date: Mar 1, 2022 to May 1, 2022v7
  14. Start date: Jan 1, 2022 to Mar 1, 2022v6
  15. Primary completion date: Sep 30, 2026 to Sep 30, 2027
    • Start date: Jul 1, 2021 to Jan 1, 2022
    • Study completion date: Dec 30, 2026 to Dec 30, 2027
    v5
  16. Primary completion date: Sep 30, 2025 to Sep 30, 2026
    • Start date: Jul 1, 2020 to Jul 1, 2021
    • Study completion date: Dec 30, 2025 to Dec 30, 2026
    v4
  17. Primary completion date: Sep 30, 2023 to Sep 30, 2025
    • Start date: Oct 1, 2019 to Jul 1, 2020
    • Study completion date: Sep 30, 2023 to Dec 30, 2025
    • Study description expanded, about 21 words
    v3
  18. Study description revisedv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03825835
Lead Sponsor University of Alberta
Collaborators: University of Toronto, University of Sydney, Dalhousie University, McMaster University, University of Manitoba, McGill University, University of Calgary, Memorial University of Newfoundland, University College Cork, University of British Columbia, Laval University, Université de Montréal, University of Ottawa, Queen's University, Université de Sherbrooke
Conditions
(from sponsor)		 Premature Infant, Respiratory Distress Syndrome in Premature Infant, Neurodevelopmental Outcome
Related terms Premature Birth
Enrollment 1,203 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov