E16.2
Conditions
Interventions
Group 1: Prospective cohort: treatment according to new neonatal hypoglycemia guildeline.
Group 2: Retrospective cohort: treatment of neonatal hypoglycemia before implementation of the new guideline
Sponsors
Heinrich-Heine Universität
Eligibility
Sex/Gender
All
Age
No minimum to 11 Years
Inclusion criteria
Inclusion criteria: Newborns with and without hypoglycemia born at the University Hospital Düsseldorf between March 2018 - June 2022 or 2010 - 2015
Exclusion criteria
Exclusion criteria: Lack of parental consent. Prematurity <35+0 weeks gestation. Excluded for analysis of the primary endpoint are all children in whom another nonhyperglycemic cause of developmental disability is/will be known. Patients receiving glycemic therapy (e.g., infusion/gastric tube during CPAP or similar) due to another clinical indication (not hypoglycemia) will remain in the study and may only be excluded from certain endpoints in the analysis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neurological outcome in Bayley Scales of Infant Development (BSID-II) at 2 years of age and in Wechsler Intelligence Scale for Children (WISC-V) at 7-11 years of age. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Hospitalization rate and duration - Frequency and duration of separation of mother and child due to hypoglycemic treatment - number of blood glucose measurements - Number and timing of hypoglycemic episodes - Number of severe hypoglycemia <30 mg/dl despite treatment - Age in hours at last routine blood glucose measurement - Duration of hypoglycemia (from time of hypoglycemia detection to blood glucose value in target range) - Number/duration of different interventions according to internal standard of care - Number of patients with suspected transient hyperinsulinism - Average duration of therapy - Average increase in blood glucose after intervention according to standard of care until next measurement for the different treatment interventions (dextrose gel, glucagon, intravenous glucose, nutricion) - Number of rebound hypoglycemia (hypoglycemia within 6 hours after initial correction). - Incidences of risk factors for neonatal hypoglycemia - Correlation between maternal HbA1c level (if known) and incidence of neonatal hypoglycemia - Correlation and postnatal course of blood glucose levels, keton body and lactate concentrations - Proportion of fully breastfed infants (at discharge, after 4-6 weeks, at 6 months of age) - Nutritional intake in the first days of life (volume and frequency of administration of breast milk, formula, i.v. glucose, glucose gel) - Correlation of number, duration, and severity of hypoglycemia and delayed achievement of developmental milestones - Occurrence of seizures - Correlation of ketone body and lactate concentration with the occurrence of seizures - Correlation of ketone body/lactate concentration and food (breast milk vs. formula) - Correlation of blood glucose, ketone body and lactate concentrations with neurological outcome - abnormalities in MRI or EEG - Visual disturbances at the age of 2 years/7-11 years - Hearing disorders at the age of 2 years/7-11 years - Cerebral palsy at the age of 2 years/7-11 | — |
Countries
Germany
Contacts
Public ContactThomas Meissner
Klinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie Universitätsklinikum Düsseldorf
Outcome results
None listed