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The Hilo Trial to Improve Neurodevelopmental Outcomes in Very Low Birthweight Infants - Pilot-trial (HiLo-Pilot)

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ClinicalTrials.gov Identifier: NCT03706586
Recruitment Status : Completed
First Posted : October 16, 2018
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
University of Alberta

Brief Summary:
Preterm birth, or birth before 37 weeks' gestation, is increasingly common, occurring in 8% 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. Our 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. During the first 2 months of the clinical trial we will treat all babies less than 29 weeks' gestation who need resuscitation with the oxygen concentration we are randomly assigned. Then in the next 2 months, we will treat babies using the other oxygen concentration. After the trial, we will determine whether the babies resuscitated with low oxygen or those resuscitated with high oxygen have better survival and long-term health outcomes. Our research fills a critical knowledge gap in the care of extremely preterm babies and will impact their survival both here in Canada and internationally.

Condition or disease Intervention/treatment Phase
Premature Infant Respiratory Distress Syndrome Procedure: 30% group Procedure: 60% group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: outcome assessed will be unaware of group allocation
Primary Purpose: Prevention
Official Title: Does the Use of Higher Versus Lower Oxygen Concentration Improve Neurodevelopmental Outcomes at 18-24 Months in Very Low Birthweight Infants: a Pilot Trial
Actual Study Start Date : November 1, 2018
Actual Primary Completion Date : February 28, 2019
Actual Study Completion Date : March 31, 2019


Arm Intervention/treatment
Active Comparator: 30% group
Infants in the 30 % 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.
Procedure: 30% group
Infants in the 30 % 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.

Experimental: 60% group
Infants in the 60 % 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.
Procedure: 60% group
Infants in the 60 % 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.




Primary Outcome Measures :
  1. Neurodevelopmental outcomes at 18-24 months [ Time Frame: 18-24 months of age ]
    At 18-24 months corrected age, the infants will be assessed using the Bayley Scales of Infant Development-3rd edition (Bayley-III). The Bayley-III has five scales: i) Cognition Scale (e.g., attention to familiar and unfamiliar objects); ii) Language Scale (e.g., understanding and expression of language); iii) Motor Scale (e.g., gross and fine motor skills); iv) Social-Emotional Scale; and v) the Adaptive Behavior Scale. A score 85-114 will be classified as normal, and scores <70 (2 SD below the mean of 100) will define severe cognitive delay. Audiometry will be performed to assess the presence or absence of severe hearing loss. Blindness will be defined as a corrected visual acuity of <20/200.



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Ages Eligible for Study:   up to 10 Minutes   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03706586


Locations
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Canada, Alberta
Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5H 3V9
Sponsors and Collaborators
University of Alberta
Investigators
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Principal Investigator: Georg Schmolzer University of Alberta
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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT03706586    
Other Study ID Numbers: 00084090
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Alberta:
Delivery Room
Resuscitation
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Birth Weight
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Body Weight