mOm Incubator Pilot Study

Comparison of the mOm Incubator With a Standard Incubator for the Maintenance of Thermal Stability in Preterm Infants With User Feedback

The mOm Incubator is a collapsible infant incubator designed to provide a level of thermoregulation that meets the standards set for conventional incubators whilst being low cost and space-saving. Babies recruited will be clinically stable, at least 30 weeks gestational age and require at least 48 hours incubator care. A standard or test incubator will be used for the first 24 hours chosen randomly, then the baby will be moved to the over arm for a further 24 hours.

Study Overview

• Status: Completed
• Conditions: Hypothermia
• Intervention / Treatment: Device: mOm incubator; Device: standard incubator

Detailed Description

Investigators will recruit babies who are in the Neonatal Unit at St. Peter's Hospital. Babies will be clinically stable from a cardio-respiratory point of view. They will also be requiring incubator care (so they will weigh less than approximately 1400g) but not requiring additional humidification. This effectively excludes babies born less than 30 weeks gestation who are routinely humidified for the first week (if 28-30 weeks gestation) or two weeks (if less than 28 weeks gestation). Some term babies may also be eligible for the study if they are being nursed in an incubator for clinical reasons.

Identification and recruitment of babies will be carried out by the attending Consultant Neonatologist and the research team.

For twins, consecutive enrolment will be possible if only one mOm incubator is available.

There will be two arms to the protocol. The first arm will consist of standard incubator care, where the care of the baby is unchanged, but non-invasive, more frequent (hourly) temperature and other physiological measures of stability than would normally be collected in routine care (nominally every three hours) will be collected. The second arm will be the baby receiving normal care in the mOm incubator, with another set of hourly detailed, non-invasive, observations. The planned care and monitoring of the baby will be otherwise unchanged. No additional blood tests or any other invasive testing or monitoring are required. The clinical team will have full control and responsibility for the baby's care and can terminate the study for the baby at any time for any reason.

In addition, investigators will collect the views of staff on the baby's comfort, visibility, care, usability and acceptability during each arm of the study.

For each arm of the study, the secondary outcome measures are:

(1) pulse rate (as a measure of clinical stability) (2) respiratory rate (as a measure of clinical stability) (3) apnea and bradycardia episodes recorded by nursing staff (clinical stability) (4) temperature (as a measure of clinical stability) (4) adverse events related to incubator performance (5) cleaning ease and time took (6) set up time (7) staff structured feedback

36 eligible babies will be recruited into the study at a single site, being identified by the clinical team. All 36 will experience a 24 hour period in each of the two incubators (mOm and standard) (48 hours in total), in a randomly allocated order. Babies will act as their own controls in this cross-over study design. If any babies fail to complete the 48-hour study procedures (e.g. due to data incomplete or baby withdrawn) further babies will be recruited to achieve 36 complete datasets.

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Surrey
    • Chertsey, Surrey, United Kingdom, KT16 0PZ
      • Ashford and St. Peter's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 minute to 6 months (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• At least 30 weeks gestational age and less than or equal to 6kg
• In need of at least 48 hours incubation in a stable temperature environment
• Must be clinically stable
• Parental/legal guardian written informed consent has been given

Exclusion Criteria:

• Does not require humidity regulation
• Parent/legal guardian must not be from a vulnerable group

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: standard incubator; routinely used standard incubator already used in the neonatal unit	Device: mOm incubator; 24 hour usage of test incubator; Device: standard incubator; standard incubator
Experimental: mOm incubator; new test incubator	Device: mOm incubator; 24 hour usage of test incubator; Device: standard incubator; standard incubator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
thermo-regulation	ability of incubator to maintain stable temperature of baby	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability	Time to prepare for use and clean incubator (in-use cleaning and deep clean between use)	24 hours

Collaborators and Investigators

• Sponsor: mOm incubators

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2021
• Primary Completion (Actual): August 4, 2022
• Study Completion (Actual): August 4, 2022

Study Registration Dates

• First Submitted: February 23, 2018
• First Submitted That Met QC Criteria: February 28, 2018
• First Posted (Actual): March 1, 2018

Study Record Updates

• Last Update Posted (Actual): May 22, 2024
• Last Update Submitted That Met QC Criteria: May 20, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: neonatal, incubator, thermal-regulation
• Additional Relevant MeSH Terms: Body Temperature Changes; Hypothermia
• Other Study ID Numbers: mOm/2018/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No