NCT03450668

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 1, 2018

Completed
3.7 years until next milestone

Study Start

First participant enrolled

October 27, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 4, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 4, 2022

Completed
Last Updated

May 22, 2024

Status Verified

May 1, 2024

Enrollment Period

9 months

First QC Date

February 23, 2018

Last Update Submit

May 20, 2024

Conditions

Hypothermia

Keywords

neonatal, incubator, thermal-regulation

Outcome Measures

Primary Outcomes (1)

  • thermo-regulation

    ability of incubator to maintain stable temperature of baby

    24 hours

Secondary Outcomes (1)

  • Usability

    24 hours

Study Arms (2)

standard incubator

ACTIVE COMPARATOR

routinely used standard incubator already used in the neonatal unit

Device: mOm incubatorDevice: standard incubator

mOm incubator

EXPERIMENTAL

new test incubator

Device: mOm incubatorDevice: standard incubator

Interventions

mOm incubatorDEVICE

24 hour usage of test incubator

mOm incubatorstandard incubator
standard incubatorDEVICE

standard incubator

mOm incubatorstandard incubator

Eligibility Criteria

Age1 Minute - 6 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ashford and St. Peter's Hospital

Chertsey, Surrey, KT16 0PZ, United Kingdom

Location

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Choice of incubator used is randomized and blinded until the subject has been recruited and incubator arm assigned. After which it will be known to all concerned.
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: a randomized two-arm crossover study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2018

First Posted

March 1, 2018

Study Start

October 27, 2021

Primary Completion

August 4, 2022

Study Completion

August 4, 2022

Last Updated

May 22, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)