A Randomized Control Trial of Oxygen Assist Module in Preterm Infants
Research type
Research Study
Full title
A Randomized Control Trial of Oxygen Assist Module in Preterm Infants on High Flow Nasal Cannula Therapy (ROAM)
IRAS ID
291497
Contact name
VRINDA NAIR
Contact email
Sponsor organisation
South Tees NHS Foundation Trust
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
Clinical Trial.gov, NCT04687618
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Research Summary
Oxygen treatment is common in babies born early (preterm) and requiring intensive care. Having too much or too little oxygen can increase the risk of damage to the eyes and lungs, and contribute to death or disability. Preterm infants because of their immaturity experience episodes of low oxygen levels. The low oxygen episodes are primarily due to pauses in their breathing (Apnoea of prematurity) and immaturity of their lung. These episodes persist for weeks to months. The lower the gestation at birth the longer the duration of these events. Studies have shown that these episodes of low oxygen saturations especially if frequent and prolonged is associated with poor developmental outcome, severe eye disease and lung disease.
Traditionally, the oxygen delivery is manually adjusted when infant has low oxygen saturation. However previous studies have shown despite the best efforts the oxygen level can only be maintained less than half of the time and nearly a one-fifth of the time infant spends in low oxygen levels and nearly one-third of the time in high oxygen levels. With advancement in the neonatal care, preterm infants tend to spend more time on non invasive respiratory support. Now it is possible to maintain oxygen level in target range by using automatic control of oxygen delivery on non invasive support. With the proposed study, we would like to study the efficacy of automatic control of oxygen delivery in reducing the time spent in very low and high oxygen levels when infants are on non invasive respiratory support namely High Flow Nasal Cannula support.Summary of Results
The proportion of time spent in extreme low level of oxygen (<80%) and very high levels (>98%) in premature babies receiving High Flow breathing support was significantly lower in automatic control of oxygen as compared to manual control of oxygen.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
21/NE/0035
Date of REC Opinion
23 Feb 2021
REC opinion
Further Information Favourable Opinion