Closed-loop Oxygen Control in Ventilated Infants Born at or Near Term

NCT05017727 | Completed

• 1 other identifier: 298164
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Ventilated neonates frequently require supplementary oxygen to allow for adequate oxygen delivery to the tissues and normal cell metabolism. Oxygen treatment should be monitored carefully as both excessive and inadequate dosing can have detrimental effects for the infants. Hypoxia (giving too little oxygen) increases mortality and later disability whereas hyperoxia (giving too much oxygen) increases the risk of complications such as retinopathy of prematurity and lung disease. Although very preterm and low birth weight infants represent the majority of ventilated neonates, more mature infants may also require mechanical ventilation at birth and provision of supplementary oxygen. Therefore, they may suffer from complications related to hypoxia or hyperoxia. Hence, their oxygen saturation levels and the amount of the inspired oxygen concentration provided should be continuously monitored. Oxygen control is traditionally monitored and adjusted manually by the nurse looking after the infant. Closed-loop automated oxygen control (CLAC) is a more recent approach that involves the use of a computer software incorporated into the ventilator. The software uses an algorithm that automatically adjusts the amount of inspired oxygen to maintain oxygen saturation levels in a target range. Evidence suggests that CLAC increases the time spent in the desired oxygen target range, decreases the duration of hypoxia and hyperoxia and reduces the number of manual adjustments required by clinical staff. However previous studies have been limited to very small infants. With this study the investigators aim to evaluate the effectiveness of CLAC in ventilated infants born at 34 weeks gestation and beyond. The achievement of oxygen saturation targets and the number of manual adjustments required will be compared between periods of CLAC and manual control in a cohort of patients that has not been included in previous studies and could also benefit from the intervention. The investigators will also evaluate if CLAC reduces investigations performed to ventilated babies(blood gases, X-rays).

Conditions

Pre-Term; Respiratory Disease

Outcome Measures

Primary Outcomes (1)

• The decrease in the percentage of time spent in extremes of hypoxia

  That will be assessed by evaluating the infant's respiratory status.

  Over 24 hours

Secondary Outcomes (3)

• The increase in the percentage of time spent within target oxygen saturation ranges (94-98%)

  Over 24 hours

• The reduction in the number of manual adjustments required to the inspired oxygen concentration

  Over 24 hours

• The reduction in the number of blood gases and chest radiographs

  Over 24 hours

Interventions

Closed-loop automated oxygen control with Oxygenie Auto-O2 software (SLE6000) DEVICE

The 'Oxygenie' is a closed loop automated oxygen control system that has been incorporated into a software module for the SLE6000 infant ventilators. This software control system allows targeting SpO2 values by controlling FiO2.

Eligibility Criteria

• Age: 34 Weeks+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This will be a randomised controlled crossover study. We aim to recruit a minimum of 31 ventilated infants born at 34 weeks completed gestation and above and admitted to the Neonatal Intensive Care Unit at our hospital over one year.

You may qualify if:

• Infants born at 34 weeks completed gestation and above requiring mechanical ventilation and admitted to King's NICU
• Any gender, ethnicity or other comorbidities

You may not qualify if:

• Preterm infants less than 34 weeks gestation
• Infants with cyanotic congenital heart disease
• Infants undergoing planned procedures or surgery during the monitoring period
• Infants on high frequency oscillatory ventilation (HFOV)

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead
• King's College London: collaborator

Study Sites (1)

King's College Hospital NHS Foundation Trust

London, SE5 0BD, United Kingdom

Location

Related Publications (27)

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MeSH Terms

Conditions

Premature Birth; Respiration Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Anne Greenough, Professor

  King's College Hospital/ King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: August 24, 2021
• Study Start: October 5, 2021
• Primary Completion: January 17, 2023
• Study Completion: January 17, 2023
• Last Updated: September 6, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)