NeO2Matic-Pilot Trial

NCT05629910 | Unknown

• 2 other identifiers: 22088392022051232
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The main goal of this trial is to test if: automated adjustment of supplemental oxygen to preterm infants in noninvasive respiratory support based on feedback from a measurement of blood-oxygen saturation results in more stable blood-oxygenation compared to routine nurse controlled adjustment of oxygen

Conditions

Pre-Term; Respiratory Distress Syndrome, Newborn; Retinopathy of Prematurity; Bronchopulmonary Dysplasia

Keywords

closed loop oxygen control

Outcome Measures

Primary Outcomes (1)

• time in target SpO2 range 90%-95% (90%-100% if FiO2 =21%)

  total time spent in target SpO2 range: * measured by the Nonin pulse oximeter connected to O2Matic and/or * measured by the Avant 9600 Nonin Pulse oximeter providing data from this pulse oximeter

  48 hours

Secondary Outcomes (9)

• number of episodes of SpO2 below 80% lasting at least 60 seconds

  48 hours

• relative SpO2 distribution in the ranges <80%, 81-85%, 86-89%, 90-95%, >95%

  48 hours

• burden of hypoxia, i.e. the 'area under the curve' using spO2 = 80% as the threshold

  48 hours

• duration of episodes with SpO2 above 95% or below 90%

  48 hours

• frequency of episodes with SpO2 above 95% or below 90%

  48 hours

Study Arms (2)

Interventional period: Automated adjustment of FiO2 by O2Matic

EXPERIMENTAL

During the interventional period the O2Matic will operate in automatic mode using the Neonatal Study Profile. O2Matic will continuously adjust the O2 flow to adjust SpO2 within range based on readings from the pulse oximeter connected to O2Matic, while AIRVO-2 will adjust the flow of ambient air to keep the total gas flow constant.

Device: O2Matic

Control period - manual adjustment of FiO2

NO INTERVENTION

During the control period, the bedside nurse will manually change FiO2 as per routine based on the reading from the Avant 9600 Nonin pulse oximeter connected to the central monitoring system), by changing oxygenflow from O2Matic as required to induce appropriate changes in SpO2:

Interventions

O2Matic DEVICE

During the interventional period the O2Matic will operate in automatic mode using the Neonatal Study Profile. O2Matic will continuously adjust the O2 flow to adjust SpO2 within range based on readings from the pulse oximeter connected to O2Matic, while AIRVO-2 will adjust the flow of ambient air to keep the total gas flow constant.

Interventional period: Automated adjustment of FiO2 by O2Matic

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Newborn infants receiving nHFT via Optiflow 4-8 l/min and FiO2\>0.25, requiring adjustments of FiO2 beyond the extra need during care procedures
• Likely to be maintained on nHFT during study period of 48 hrs

You may not qualify if:

• major congenital abnormalities
• hemodynamic instability including large PDA with right to left shunting
• clinician's concern regarding infant stability.
• Unstable infants with frequent apneas, predominantly having need for oxygen during apneic events

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Department of Neonatology, Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Premature Birth; Respiratory Distress Syndrome, Newborn; Retinopathy of Prematurity; Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Retinal Diseases; Eye Diseases; Ventilator-Induced Lung Injury; Lung Injury

Study Officials

• Christian Heiring

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian Heiring

CONTACT

+4535453545; christian.heiring@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study is a pilot trial and designed as a order-randomized, cross-over trial. Infants will be randomised to treatment-order by block randomisation to ensure even distribution between the sequence of treatment. All infants will at study start receive nHFT via OptiFlow interface, and then be allocated to: ▪ Automated adjustment of FiO2 by O2Matic followed by manual FiO2 adjustment or ▪ Manual adjustment of FiO2 followed by Automated adjustment of FiO2 by O2Matic Each patient will serve as their own control, and each treatment-period will last 24 hours, and each patient will be exposed to 1 period of each treatment assignment.

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 29, 2022
• Study Start: January 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: July 1, 2025
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

DK (1)