Measuring Oxygenation of Newborn Infants in Targeted Oxygen Ranges

NCT03360292 | Completed

• 2 other identifiers: AC17098194632
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aim to measure the effect of targeting premature babies to a slightly higher oxygen saturation target range (92-97%) than routinely used, for a brief period, to plan a future larger study of the effect of this on clinical outcomes. It is still unclear exactly what levels of oxygen premature babies need - both too little or too much oxygen in the first weeks after birth may be harmful. Previous studies used saturation monitoring (SpO2), where a small probe shines light through the skin and calculates how much oxygen is carried in the blood. These studies demonstrated using an SpO2 range of 91-95% rather than 85-89% was associated with more babies surviving and fewer babies suffering from a bowel condition called necrotising enterocolitis (NEC). However, targeting oxygen higher increased the number of infants who needed treatment for an eye condition called retinopathy of prematurity (ROP). It is possible an SpO2 range higher than 91-95% would be associated with even better survival. It is also possible that a higher range might not improve survival but could increase the need for ROP treatment. Infants born at less than 29 weeks gestation, greater than 48 hours of age and receiving supplementary oxygen would be eligible for inclusion. The study is at the Royal Infirmary of Edinburgh. Total study time is 12 hours for each infant (6 hours at the standard 90-95% range used in our unit, and 6 hours at 92-97%). It is a crossover study with infants acting as their own controls. Based on previous research the investigators are confident these oxygen levels will not be dangerously high. To provide an additional measure of oxygen the investigators will also use a transcutaneous monitor for the 12 hour study period, which fastens gently to the skin and measures oxygen and carbon dioxide levels on the skin surface.

Conditions

Premature Infant; Hypoxia; Hyperoxia

Keywords

Neonatology

Outcome Measures

Primary Outcomes (1)

• Incidence of hyperoxia and hypoxia on saturations

  Percentage time spent above an SpO2 of 97% and below an SpO2 of 90% when infants are targeted to an SpO2 range of 92-97% compared to 90-95%

  12 hours

Secondary Outcomes (6)

• Incidence of hyperoxia and hypoxia on Transcutaneous monitoring

  12 hours

• Saturation variability

  12 hours

• Transcutaneous variability

  12 hours

• Characterise PaO2 values within the two oxygen saturation target ranges

  12 hours

• Pooled frequency histogram of SpO2

  12 hours

Study Arms (2)

Higher target range

EXPERIMENTAL

Infants will be targeted to 92-97% oxygen saturation

Other: Higher target range

Standard target range

NO INTERVENTION

Infants will be targeted to 90-95% oxygen saturation, which is the range used as routine in the Neonatal Unit involved in the study

Interventions

Higher target range OTHER

Intervention is using a higher oxygen saturation target range than in routine practice

Also known as: Using a higher oxygen saturation target range

Higher target range

Eligibility Criteria

• Age: 48 Hours - 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

You may not qualify if:

• Congenital anomalies that would affect oxygenation (eg. cardiac defects, congenital diaphragmatic hernia)

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Lothian: collaborator

Study Sites (1)

Neonatal Unit - Royal Infirmary of Edinburgh

Edinburgh, Lothian, EH16 4SA, United Kingdom

Location

Related Publications (1)

• Christie FG, Kelly R, Boardman JP, Stenson BJ. Measuring Oxygenation in Newborn Infants with Targeted Oxygen Ranges (MONITOR): a randomised crossover pilot study. Arch Dis Child Fetal Neonatal Ed. 2023 Nov;108(6):638-642. doi: 10.1136/archdischild-2022-324833. Epub 2023 May 4.

  PMID: 37142388 DERIVED

MeSH Terms

Conditions

Premature Birth; Hypoxia; Hyperoxia

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; 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: Infants will be randomised to either higher (92-97%) or lower (90-95%) oxygen saturation target range, and then cross-over to the alternative range after 6 hours of monitoring (with 12 hours in total study time). The study is randomised but not blinded.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 4, 2017
• Study Start: January 18, 2020
• Primary Completion: May 18, 2021
• Study Completion: February 17, 2022
• Last Updated: March 28, 2022

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)