NCT06932354

Brief Summary

This study aims to determine if CGM can be safely used in these babies, and to use this alongside innovative methods to measure alternative fuels to optimise care of these vulnerable babies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 10, 2019

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 17, 2025

Completed
Last Updated

April 17, 2025

Status Verified

April 1, 2025

Enrollment Period

3.6 years

First QC Date

January 26, 2021

Last Update Submit

April 15, 2025

Conditions

Hypoxic-Ischemic Encephalopathy

Outcome Measures

Primary Outcomes (1)

  • Percent of time glucose levels measured on CGM are in target

    Percent Time in target (2.6-10mmol/l)

    From sensor insertion for up to the first 7 days of life

Interventions

CGMDEVICE

masked continuous glucose monitoring

Eligibility Criteria

AgeUp to 2 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Hypoxic ischaemic encephalopathy Informed parental consent

You may not qualify if:

  • Known significant congenital malformation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cambridge University Addenbrookes Hospital Trust

Cambridge, cambridge, CB2 0QQ, United Kingdom

Location

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain

Condition Hierarchy (Ancestors)

Brain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypoxia, BrainVascular DiseasesCardiovascular DiseasesHypoxiaSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

January 26, 2021

First Posted

April 17, 2025

Study Start

May 10, 2019

Primary Completion

December 1, 2022

Study Completion

December 31, 2024

Last Updated

April 17, 2025

Record last verified: 2025-04

Locations

GB(1)