A Study of Agreement Between Oxygen Saturation Measured by Two Probes in Infants on the Neonatal Unit

NCT05065229 | Completed

• 1 other identifier: IRAS 297715
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

On the neonatal unit in Derby, two types of probes are in routine use: Mindray 520 N and Mindray 521 N. Feedback from parents and staff show that there are concerns that the two probes given very different oxygen saturation readings and, often, do not agree with each other. This has raised concerns that infants' clinical care may be affected by the choice of probe. It is important to know if the two probes give similar results or not to ensure that infants get the appropriate monitoring and respiratory support as needed for good neonatal care. In this study, we will compare the reading made by the two probes and determine whether the readings of the two probes agree with each other and if any disagreement is such that clinical decision making is affected by the difference.

Conditions

Neonatal Disease

Outcome Measures

Primary Outcomes (1)

• oxygen saturation of babies using Minday 520 N and Minday 521 N

  Oxygen saturation readings using Minday 520 N and Minday 521 N probes simultaneously

  12 months

Secondary Outcomes (1)

• clinical decision making

  12 months

Study Arms (2)

A

EXPERIMENTAL

Right foot no.520 Left foot no.521

Device: Oxygen saturation probe Mindray 520 N and Mindray 521 N

B

EXPERIMENTAL

Right foot no.521 Left foot no.520

Device: Oxygen saturation probe Mindray 520 N and Mindray 521 N

Interventions

Oxygen saturation probe Mindray 520 N and Mindray 521 N DEVICE

Two oxygen saturation probes will be used in this study: Mindray 520 N is a disposable oxygen saturation sensor for neonates and adults. It is a disposable, single-use sensor that is wrapped around the infant's arm or foot. Its ends stick together giving a firm, close contact with the skin. Mindray 521 N is another disposable oxygen saturation sensor for neonates and adults that is used on the neonatal unit in routine practice. As Mindray 520 N and 521 N are CE marked and used within their intended purposes we do not require a letter of no objection from the MHRA for that usage. The Mindray probes will be used without modification and there are no safety issues to the patient. Therefore, a letter of no objection from the MHRA is not required and this is not a medical device study under the Medical Devices Directive.

A; B

Eligibility Criteria

• Age: 32 Weeks - 60 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infants who need oxygen saturation monitoring for clinical care
• Infants born preterm (\<37 weeks' gestation) who are \< 7 days of age and need respiratory support including supplemental oxygen
• Infants born preterm (\<37 weeks' gestation) who are in supplemental oxygen at \>34 weeks' gestation
• Infants born at term gestation (\< 37 weeks' gestation) who require respiratory support including supplemental oxygen
• Infants with suspected cardiac disease

You may not qualify if:

• Infants who have intravenous or arterial lines attached to either foot.
• Infants who have any condition that may cause differential oxygen saturation or blood flow to the lower limbs such as venous thrombosis.
• Infants who have local infections or skin lesions on either foot.
• Infants older than 5 months of age

Sponsors & Collaborators

• University of Nottingham: lead
• University Hospitals of Derby and Burton NHS Foundation Trust: collaborator

Study Sites (1)

University Hospitals of Derby and Burton

Derby, Derbyshire, DE3 0ED, United Kingdom

Location

MeSH Terms

Conditions

Infant, Newborn, Diseases

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• shalini ojha

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A computer-generated random number sequence will be obtained to determine which probe is attached to which foot. The sequence will be kept in opaque, sequentially numbered envelopes that will be opened just before the probes are attached to the feet of the participant. The clinical team nurse who will record the oxygen saturation readings will be blinded to which probe is attached to which foot by covering the feet securely after the probes have been attached. The probes will be designated as A and B. The study statistician will be blind to which probe is A and which is B until all data analyses are completed.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel group, randomised study

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: October 4, 2021
• Study Start: July 15, 2021
• Primary Completion: January 11, 2023
• Study Completion: January 14, 2023
• Last Updated: September 8, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)