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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

Must not have

Infants who are born with a major congenital abnormality- congenital abnormalities may affect oxygenation or neurodevelopmental outcomes

Infants who are not born within the eligible gestational age range- this trial is specific to preterm infants

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24+/- 6 months of age

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My baby was born between 23 and 29 weeks without major birth defects and received full resuscitation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My infant was born with a major birth defect.

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My baby was born prematurely.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24+/- 6 months of age

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24+/- 6 months of age

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24+/- 6 months of age for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Blindness

Hearing loss

Mortality

+1 more

Secondary study objectives

Death in the Neonatal Intensive Care Unit

Death in the delivery room

Number of intubation in the delivery room

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 3Eligibility criteria met