The Hilo Pilot -Trial to Assess Feasibility

NCT03706586 | Completed

• 1 other identifier: 00084090
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Infant; Respiratory Distress Syndrome

Keywords

Delivery Room; Resuscitation

Outcome Measures

Primary Outcomes (1)

• Feasibility of 30% or 60% oxygen at birth

  Titration oxygen during respiratory support at birth

  10 Minutes after birth

Study Arms (2)

30% group

ACTIVE COMPARATOR

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

60% group

EXPERIMENTAL

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

Interventions

30% group PROCEDURE

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.

30% group

60% group PROCEDURE

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.

60% group

Eligibility Criteria

• Age: Up to 10 Minutes
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

Location

Related Publications (1)

• Law BHY, Asztalos E, Finer NN, Yaskina M, Vento M, Tarnow-Mordi W, Shah PS, Schmolzer GM. Higher versus Lower Oxygen Concentration during Respiratory Support in the Delivery Room in Extremely Preterm Infants: A Pilot Feasibility Study. Children (Basel). 2021 Oct 20;8(11):942. doi: 10.3390/children8110942.

  PMID: 34828655 DERIVED

MeSH Terms

Conditions

Premature Birth; Respiratory Distress Syndrome

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Georg Schmolzer

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: outcome assessed will be unaware of group allocation
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: October 16, 2018
• Study Start: November 1, 2018
• Primary Completion: February 28, 2019
• Study Completion: March 31, 2019
• Last Updated: September 5, 2021

Record last verified: 2021-09

Locations

CA (1)