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

NCT04687618 | Unknown DMC

• 1 other identifier: 291497
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Birth

Keywords

Preterm; High Flow Nasal Cannula

Outcome Measures

Primary Outcomes (1)

• Proportion of time spent in extreme saturation (<80% and >98%) in preterm infants receiving HFNC as respiratory support.

  The primary outcome of this study is proportion of time spent in extreme saturation (\<80% and \>98%) in preterm infants receiving HFNC as respiratory support.

  Through study completion on an average of 3 months

Secondary Outcomes (3)

• Proportion of time spent in target saturation

  Through study completion on an average of 3 months

• Proportion of time spent in saturation >95%

  Through the study completion on an average of 3 months

• episodes of prolonged hypoxemia (SpO2 < 80% for more than 60 sec)

  Through study completion on an average of 3 months

Study Arms (2)

Automatic control of FiO2

EXPERIMENTAL

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.

Device: High Flow Nasal Cannula withAutomatic control of FiO2 using OAM

Manual Control of FiO2

ACTIVE COMPARATOR

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.

Device: High Flow Nasal Cannula with manual control of FiO2

Interventions

High Flow Nasal Cannula withAutomatic control of FiO2 using OAM 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).

Automatic control of FiO2

High Flow Nasal Cannula with manual control of FiO2 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%.

Manual Control of FiO2

Eligibility Criteria

• Age: 23 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• South Tees Hospitals NHS Foundation Trust: lead
• Vapotherm, Inc.: collaborator

Study Sites (1)

James Cook University Hospital

Middlesbrough, TS4 3BW, United Kingdom

RECRUITING

Related Publications (6)

• 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.

  PMID: 20732945 BACKGROUND

• 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.

  PMID: 21986336 BACKGROUND

• 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.

  PMID: 20472937 BACKGROUND

• 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.

  PMID: 30464005 BACKGROUND

• 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.

  PMID: 26194933 BACKGROUND

• 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.

  PMID: 37451840 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Vrinda Nair

  South Tees NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vrinda Nair, M.D,FRCPCH

CONTACT

01642854874; vrinda.nair1@nhs.net

Joe Millar

CONTACT

joe.millar@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised Control Trial

Study Record Dates

• First Submitted: November 1, 2020
• First Posted: December 29, 2020
• Study Start: April 15, 2021
• Primary Completion: December 31, 2022
• Study Completion: April 30, 2023
• Last Updated: April 27, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)