Oxygen Assist Module in Preterm Infants on High Flow Nasal Cannula Support.

NCT ID: NCT04687618

Last Updated: 2021-04-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-15
• Study Completion Date: 2023-04-30

Brief 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.

Detailed 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 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.

Conditions

Preterm Birth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Automatic control of FiO2

Infants randomized to this arm will be monitored using automatic oxygen control system on the High Flow Nasal Cannula. When infants oxygen saturation are out of the target range the OAM module on HFNC will adjust the oxygen delivery depending on the saturation of the infant to bring the saturation in the target range.

Group Type: EXPERIMENTAL

High Flow Nasal Cannula withAutomatic control of FiO2 using OAM

Intervention Type: DEVICE

The target oxygen saturation (SpO2) value will to be determined and set by the clinician according to specific patient needs. The target SpO2 in preterm infants is 90-95% with alarm limits at 89-96%. In automatic control of oxygen, the OAM automatically increases or decreases the FiO2 (oxygen delivery) setting on the Vapotherm Precision Flow based on pulse oximetry readings of the OAM. The target saturation will be set at 93% and the FiO2 will be adjusted by OAM to maintain the target saturation. The automated FiO2 setting can be overridden for a clinician pre-set period of time (30-120 sec) by simply manually adjusting the FiO2 on the Precision Flow. Automated control resumes after the clinicians pre-set period of time (30-120 sec) based on the current SpO2 and FiO2. The OAM utilizes a feedback control algorithm that receives a patient's oxygen saturation value from a build in pulse oximetry device (Masimo SET OEM - normal sensitivity, averaging time window set at 8 seconds).

Manual Control of FiO2

Infants randomized to this arm will be receive oxygen delivery adjustments manually by the nursing and medical team taking care of the infants. When the infants oxygen saturation are out of the target range, the staff will manually adjust the oxygen delivery.

Group Type: ACTIVE_COMPARATOR

High Flow Nasal Cannula with manual control of FiO2

Intervention Type: DEVICE

In manual control of oxygen all FiO2 adjustments will be done by the clinical staff to maintain saturations between 90-95%. The alarm limits will be 89-96%.

Interventions

High Flow Nasal Cannula withAutomatic control of FiO2 using OAM

The target oxygen saturation (SpO2) value will to be determined and set by the clinician according to specific patient needs. The target SpO2 in preterm infants is 90-95% with alarm limits at 89-96%. In automatic control of oxygen, the OAM automatically increases or decreases the FiO2 (oxygen delivery) setting on the Vapotherm Precision Flow based on pulse oximetry readings of the OAM. The target saturation will be set at 93% and the FiO2 will be adjusted by OAM to maintain the target saturation. The automated FiO2 setting can be overridden for a clinician pre-set period of time (30-120 sec) by simply manually adjusting the FiO2 on the Precision Flow. Automated control resumes after the clinicians pre-set period of time (30-120 sec) based on the current SpO2 and FiO2. The OAM utilizes a feedback control algorithm that receives a patient's oxygen saturation value from a build in pulse oximetry device (Masimo SET OEM - normal sensitivity, averaging time window set at 8 seconds).

Intervention Type: DEVICE

High Flow Nasal Cannula with manual control of FiO2

In manual control of oxygen all FiO2 adjustments will be done by the clinical staff to maintain saturations between 90-95%. The alarm limits will be 89-96%.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Preterm infants {born at a gestation <33 weeks (23+0 to 32+6 weeks) }
• Receiving HFNC as respiratory support anytime during their stay in the neonatal support

Exclusion Criteria

• Preterm infants more than equal to 33 weeks.
• Preterm infants with major congenital or chromosomal anomalies

• Minimum Eligible Age: 23 Weeks
• Maximum Eligible Age: 32 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vapotherm, Inc.

INDUSTRY

Sponsor Role: collaborator

South Tees Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vrinda Nair

Role: PRINCIPAL_INVESTIGATOR

South Tees NHS Trust

Locations

James Cook University Hospital

Middlesbrough, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Vrinda Nair, M.D,FRCPCH

Role: CONTACT

vrinda.nair1@nhs.net

01642854874

Joe Millar

Role: CONTACT

joe.millar@nhs.net

Facility Contacts

Vrinda Nair, MBBS, M.D, FRCPCH

Role: primary

vrinda.nair1@nhs.net

References

Stoll BJ, Hansen NI, Bell EF, Shankaran S, Laptook AR, Walsh MC, Hale EC, Newman NS, Schibler K, Carlo WA, Kennedy KA, Poindexter BB, Finer NN, Ehrenkranz RA, Duara S, Sanchez PJ, O'Shea TM, Goldberg RN, Van Meurs KP, Faix RG, Phelps DL, Frantz ID 3rd, Watterberg KL, Saha S, Das A, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Neonatal outcomes of extremely preterm infants from the NICHD Neonatal Research Network. Pediatrics. 2010 Sep;126(3):443-56. doi: 10.1542/peds.2009-2959. Epub 2010 Aug 23.

Reference Type: BACKGROUND

PMID: 20732945 (View on PubMed)

Martin RJ, Wang K, Koroglu O, Di Fiore J, Kc P. Intermittent hypoxic episodes in preterm infants: do they matter? Neonatology. 2011;100(3):303-10. doi: 10.1159/000329922. Epub 2011 Oct 3.

Reference Type: BACKGROUND

PMID: 21986336 (View on PubMed)

SUPPORT Study Group of the Eunice Kennedy Shriver NICHD Neonatal Research Network; Carlo WA, Finer NN, Walsh MC, Rich W, Gantz MG, Laptook AR, Yoder BA, Faix RG, Das A, Poole WK, Schibler K, Newman NS, Ambalavanan N, Frantz ID 3rd, Piazza AJ, Sanchez PJ, Morris BH, Laroia N, Phelps DL, Poindexter BB, Cotten CM, Van Meurs KP, Duara S, Narendran V, Sood BG, O'Shea TM, Bell EF, Ehrenkranz RA, Watterberg KL, Higgins RD. Target ranges of oxygen saturation in extremely preterm infants. N Engl J Med. 2010 May 27;362(21):1959-69. doi: 10.1056/NEJMoa0911781. Epub 2010 May 16.

Reference Type: BACKGROUND

PMID: 20472937 (View on PubMed)

Reynolds PR, Miller TL, Volakis LI, Holland N, Dungan GC, Roehr CC, Ives K. Randomised cross-over study of automated oxygen control for preterm infants receiving nasal high flow. Arch Dis Child Fetal Neonatal Ed. 2019 Jul;104(4):F366-F371. doi: 10.1136/archdischild-2018-315342. Epub 2018 Nov 21.

Reference Type: BACKGROUND

PMID: 30464005 (View on PubMed)

Lal M, Tin W, Sinha S. Automated control of inspired oxygen in ventilated preterm infants: crossover physiological study. Acta Paediatr. 2015 Nov;104(11):1084-9. doi: 10.1111/apa.13137.

Reference Type: BACKGROUND

PMID: 26194933 (View on PubMed)

Nair V, Kannan Loganathan P, Lal MK, Bachman TE, Fantl R. Randomised control trial of oxygen assist module in preterm infants on high-flow nasal cannula support. Arch Dis Child Fetal Neonatal Ed. 2023 Dec 15;109(1):65-69. doi: 10.1136/archdischild-2023-325661.

Reference Type: DERIVED

PMID: 37451840 (View on PubMed)

Other Identifiers

291497

Identifier Type: -

Identifier Source: org_study_id