hypo- and hyperglycaemia in premature children
Conditions
Interventions
Glucose
premature
Sponsors
Cambridge University Hospitals NHS Foundation Trust and University of Cambridge
Eligibility
Age
2 Years to 11 Years
Inclusion criteria
Inclusion criteria: * Informed consent of the parents * * 33+6 weeks gestation * * 24 hours of age * Birth weight * 1200 g
Exclusion criteria
Exclusion criteria: * A fatal congenital defect known at the time of enrolment in the study. * All congenital metabolic disorders known at the time of enrolment in the study. * Newborns who in the opinion of the treating doctor have no realistic prospect of survival at the time of enrolment in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time percentage of sensor glucose (SG) within the target of 2.6-10 mmol/L within the first six days of life of premature children | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy 1) Mean sensor glucose (SG) in the first six days. 2) Time percentage of SG within the target of 4-8 mmol/L within the first six days of life 3) SG variability in individuals as established by standard deviation in the patient 4) Time percentage of glucose levels in hyperglycaemic region - SG > 15 mmol/L Acceptability 1) Assessment score of the clinical staff on the impact on clinical care 2) Frequency of blood glucose monitoring 3) Clinical use of algorithm Safety 1) Incidence of hypoglycaemia defined as an episode of blood glucose >2.2 mmol/L and 1 hour 3) Incidence of severe hypoglycaemia defined as an episode of BG *2.2 mmol/L Economic aspects for health care * Cost efficiency expressed in terms of increasing costs per additional case of adequate glucose control between 2.6 mmol/L - 10 mmol/L | — |
Countries
Netherlands, Spain, United Kingdom
Outcome results
None listed