Servo Controlled Oxygen Targeting Study

NCT04177992 | Completed

• 1 other identifier: AC19110
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Most premature babies require oxygen therapy. There is uncertainty about what oxygen levels are the best. The oxygen levels in the blood are measured using a monitor called a saturation monitor and the oxygen the baby breathes is adjusted to keep the level in a target range. Although there is evidence that lower oxygen levels maybe harmful, it is not known how high they need to be for maximum benefit. Very high levels are also harmful. Saturation monitors are not very good for checking for high oxygen levels. For this a different kind of monitor, called a transcutaneous monitor, is better. Keeping oxygen levels stable is usually done by nurses adjusting the oxygen levels by hand (manual control). There is also equipment available that can do this automatically (servo control). It is not known which is best. Studies of automated control have shown that infants spend more time within their intended target oxygen saturation range. These have not included measurements of transcutaneous oxygen. The investigators aim to show the transcutaneous oxygen levels as well as the oxygen saturation levels when babies have their oxygen adjusted manually or automatically.

Conditions

Premature Infant; Oxygen Therapy; Hypoxia; Hyperoxia; Obstetric Labor, Premature

Keywords

Neonatology; Servo-control; Transcutaneous oxygen; Saturation monitoring

Outcome Measures

Primary Outcomes (1)

• Incidence of hyperoxia and hypoxia on transcutaneous monitoring

  To discover the percentage time spent within a TcPO2 range of 50mmHg (6.7kPa) - 80mmHg (10.7kPa) when infants are targeted to an SpO2 range of 90-95% using automated (servo) versus manual control.

  12 hours

Secondary Outcomes (8)

• Transcutaneous oxygen variability

  12 hours

• Incidence of hyperoxia and hypoxia on saturation monitoring

  12 hours

• Saturation variability

  12 hours

• Fraction of inspired oxygen variability

  12 hours

• Pooled frequency histogram of TcPO2

  12 hours

Study Arms (2)

Servo control

EXPERIMENTAL

Automated control of oxygen. The oxygen saturation target range will be set to 93%. Automated oxygen control can be over-ridden by manual adjustment of oxygen at any time if this is considered necessary to optimise control of oxygenation according to current clinical targets.

Other: Servo control

Manual control

NO INTERVENTION

Standard practice. Oxygen adjustments will be made by clinical/nursing staff to maintain a target oxygen range of 90%-95%.

Interventions

Servo control OTHER

FiO2 adjustments will be made by one of two respiratory devices depending on the clinical requirements and current ventilatory therapy of the infant

Servo control

Eligibility Criteria

• Age: Up to 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants born at less than 29 weeks gestation
• Infants greater than 48 hours of age
• Infants who are receiving supplementary oxygen
• Person with parental responsibility able to give consent

You may not qualify if:

• Congenital anomalies that would prevent targeting SpO2 to 90-95% (e.g. cardiac defects)
• Clinical condition of an infant would impair accurateTcPO2 measurement (e.g. impaired perfusion or requirement of inotropic or vasopressor support)

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Lothian: collaborator

Study Sites (1)

The Simpson Centre for Reproductive Health, Royal Infirmary Edinburgh

Edinburgh, EH16 4SA, United Kingdom

Location

MeSH Terms

Conditions

Premature Birth; Hypoxia; Hyperoxia; Obstetric Labor, Premature

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The study is randomised but not blinded. Infants will be randomised to commence on either automated (servo) control or manual mode, and then cross-over to the alternative range after 6 hours of monitoring (total study time of 12 hours). SpO2 (range 90-95%) will be continuously monitored as per normal standard of care.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomised cross-over study of servo-controlled oxygen targeting in premature infants, with infants acting as their own controls.

Study Record Dates

• First Submitted: November 22, 2019
• First Posted: November 26, 2019
• Study Start: January 16, 2020
• Primary Completion: January 6, 2021
• Study Completion: January 6, 2021
• Last Updated: March 14, 2022

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)