Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Preterm Birth
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomised Control TrialMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Younger than 2332 years
Gender
Both males and females

Description

Supplemental oxygen remains by far the most commonly used 'drug' in neonatal intensive care units. The goal of oxygen therapy is to maintain normal oxygenation while minimizing hypoxemia and hypoxemia. Preterm infants are particularly vulnerable to oxygen toxicity and oxidative stress leading to ret...

Supplemental oxygen remains by far the most commonly used 'drug' in neonatal intensive care units. The goal of oxygen therapy is to maintain normal oxygenation while minimizing hypoxemia and hypoxemia. Preterm infants are particularly vulnerable to oxygen toxicity and oxidative stress leading to retinopathy of prematurity (ROP), bronchopulmonary dysplasia (BPD), and periventricular leukomalacia (PVL). It's also well known that preterm infants experience hypoxic events which are primarily linked to cardiovascular instability and apnea of prematurity. These events vary as the infant matures. Martin R et al showed in their study that these hypoxic events peaked around 2-4 weeks and decreases by 6-8 weeks in preterm infants . Exposure to prolonged and frequent hypoxemic episodes has been associated with increased morbidity and mortality . Prolonged hypoxic events (Saturation less than 80% for more than 1 minute) have been associated with severe ROP and impaired neurodevelopmental outcome in survivors . Very high oxygen levels are equally harmful. Peripheral oxygen saturation monitoring is standard of care in infants admitted to neonatal unit. Traditionally oxygen saturation (SpO2) targeting is carried out by manual adjustment of fraction of inspired oxygen (FiO2) by the caregiver based on the monitored oxygen saturation. However, in practice this is only partially achieved during routine care[6]. Hagadorn et al conducted a study in 14 centers and showed that preterm infants under 28 weeks' gestation receiving oxygen spent on average only 48% of the time with SpO2 within the prescribed target range, about 36% of the time above and 16% of the time with SpO2 below the target range. Preterm infants have frequent fluctuations in SpO2 due to their cardio-respiratory instability requiring frequent adjustments of FiO2 . Consequently, these particularly vulnerable infants spend significant time with SpO2 outside intended range and are often exposed to extremes of hypoxemia and hyperoxaemia. The automatic oxygen control system continuously monitors the oxygen saturation and adjusts the oxygen delivery to maintain oxygen saturation within the target range. The safety, feasibility and efficacy of this mode of oxygen control have already been established. Automated control of FiO2 significantly improves compliance of oxygen saturation targeting and significantly reduces exposure to hypoxemia as well as hyperoxaemia. Automatic control of oxygen delivery is available in both invasive and non-invasive mode of ventilation. The HFNC Therapy is a common mode of non-invasive respiratory support in preterm infants. Oxygen Assist Module (OAM) is a system of automatic oxygen control available in the HFNC (Vapotherm Precision Flow). Previous study looking at the efficacy of automated oxygen control with HFNC support mostly have been a crossover model and the study duration less than 48 hours . As previously mentioned, preterm infants experience hypoxic events for few weeks before cardiopulmonary maturation is established. Hence, it's important to study these events over a longer period of time. The objective of this randomized control trial is to evaluate the efficacy of OAM (Automatic oxygen Control) in reducing the extremes of oxygen saturations in preterm infants (<80% and >98%) through the entire period of HFNC respiratory support.

Tracking Information

NCT #
NCT04687618
Collaborators
Vapotherm, Inc.
Investigators
Principal Investigator: Vrinda Nair South Tees NHS Trust