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Oxygen Levels at Birth for Low Birth Weight Infants (HiLo Trial)

N/A
Recruiting
Led By Georg Schmolzer, MD, PhD
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18-24 months of age
Awards & highlights

HiLo Trial Summary

This trial is testing whether it's better to resuscitate preterm babies with low or high oxygen levels.

Who is the study for?
This trial is for very low birthweight infants born between 23 and nearly 29 weeks of gestation, who will receive full resuscitation at the study center without major congenital abnormalities. It excludes those not born in this range, with significant birth defects, or who won't get full resuscitation.Check my eligibility
What is being tested?
The trial compares two oxygen levels used during resuscitation of premature babies: one group receives 30% oxygen and another gets 60%. Hospitals are randomly chosen to use one level for the first set of infants then switch to the other for a new set.See study design
What are the potential side effects?
Potential side effects may include brain injury due to either too much or too little oxygen. The exact side effects will be studied as part of the trial's outcomes.

HiLo Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My baby was born between 23 and 29 weeks without major birth defects and received full resuscitation.

HiLo Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18-24 months of age
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18-24 months of age for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Blindness
Healing loss
Neurodevelopmental outcome at 18-24 months
Secondary outcome measures
Death in the Neonatal Intensive Care Unit
Death in the delivery room
Number of intubation in the delivery room

HiLo Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: 60% groupExperimental Treatment1 Intervention
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.
Group II: 30% groupActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

Université de MontréalOTHER
214 Previous Clinical Trials
101,571 Total Patients Enrolled
University of OttawaOTHER
207 Previous Clinical Trials
265,941 Total Patients Enrolled
University of British ColumbiaOTHER
1,417 Previous Clinical Trials
2,465,878 Total Patients Enrolled
1 Trials studying Respiratory Distress Syndrome
20 Patients Enrolled for Respiratory Distress Syndrome

Media Library

30% oxygen group (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03825835 — N/A
Respiratory Distress Syndrome Research Study Groups: 60% group, 30% group
Respiratory Distress Syndrome Clinical Trial 2023: 30% oxygen group Highlights & Side Effects. Trial Name: NCT03825835 — N/A
30% oxygen group (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03825835 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How can I apply to participate in this experiment?

"This clinical trial has a narrow qualifying criteria, requiring premature newborns aged 0 to 10 minutes. The research team is seeking 1200 participants in total."

Answered by AI

Are there vacancies available for potential participants in this experiment?

"Confirmed. According to clinicaltrials.gov, this experiment has been recruiting patients since June 27th 2022 and was recently updated on October 4th 2022."

Answered by AI

Are adults of a certain age allowed to participate in this trial?

"This experiment is seeking children between 0 and 10 years of age to participate."

Answered by AI

How many healthcare centers are investigating this clinical trial?

"This clinical trial is being run in 6 different medical centres, including the IWK Health Centre in Halifax, Hamilton Health Sciences' Neonatal Intensive Care Unit located in Hamilton, and Royal Alexandra Hospital situated in Edmonton."

Answered by AI

What is the participant quota for this clinical experiment?

"Affirmative. Clinicaltrials.gov hosts evidence that this trial is actively seeking applicants, having been initially uploaded on June 27th 2022 and last revised on October 4th 2022. The medical research has 1200 openings at 6 distinct institutions."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
30% or 60% Oxygen at Birth to Improve Neurodevelopmental Outcomes in Very Low Birthweight Infants
2022. "30% or 60% Oxygen at Birth to Improve Neurodevelopmental Outcomes in Very Low Birthweight Infants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03825835.
~781 spots leftby Sep 2027
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