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Application of opaque wrap for improving pulse oximeter sensitivity in neonates: a randomised controlled trial

Opaque wrap for PUlse oximeter Sensor in neonates

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10302534
Enrollment
100
Registered
2018-04-15
Start date
2018-06-01
Completion date
Unknown
Last updated
2020-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal oxygen saturation monitoring Neonatal Diseases

Interventions

There will be two stratum (groups) based on gestation: >27 weeks to 34 weeks
>34 weeks. This will help in having a sufficient number of small babies and validate the data in small babies. Recruitment will start after 24hrs to allow sufficient time for transition, until their h

Sponsors

North Tees and Hartlepool Hospitals NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. All infants =27 weeks of gestation 2. Neonates admitted in neonatal intensive care unit or postnatal ward 3. A parent or guardian is able and willing to provide informed consent

Exclusion criteria

Exclusion criteria: 1. Antenatal or postnatal diagnosed major congenital malformations (e.g. congenital diaphragmatic hernia, congenital heart disease, hydrops, lung malformation and known blood dyscrasias) 2. Neonates who are undergoing therapeutic hypothermia, as hypothermia could interfere in pulse oximeter sensitivity 3. Critically ill Infants based on the discretion on medical team

Design outcomes

Primary

MeasureTime frame
The time to display a valid data for the two techniques (pulse oximeter sensor with opaque wrap versus pulse oximeter sensor without opaque wrap). Total duration of recording will be for 10 minutes from the time of valid data display. Valid data as per study protocol definition. These data will be downloaded directly from both monitors into research laptop

Secondary

MeasureTime frame
1. Number of valid data points for the two techniques (OWPS and PS) during the 10 minute recording will be compared from the downloaded data 2. Number of artifacts for the two techniques (OWPS and PS) during the 10 minute recording will be compared from the downloaded data. Artifacts as per study protocol definition

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 18, 2026