P70.0 P70.1 P70.4 P70.8 P70.9 E16.1
Conditions
Interventions
Group 1: Retrospective data analysis of medical records of patients with congenital/transient/transitory hyperinsulinism
Group 2: Retrospective data analysis of medical records of patients with physio
Sponsors
Universitätsklinikum Düsseldorf
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Inclusion criteria
Inclusion criteria: Age at inclusion 0-17 years, age at diagnosis 0-48 months, inclusion period, i.e. Diagnoses within the past 10 years. At least one hypoglycemic event 10mg/kg/min as well as hypoketotic, hyperinsulinemic hypoglycemia, which persist beyond the sixth month of life. Diagnostic criteria for the investigation group "transient hyperinsulinism" are above all an increased glucose requirement of >10 mg/kg/min. Hypoketotic, hyperinsulinemic hypoglycemia confirm the diagnosis, but are not mandatory as the corresponding hormones/metabolites are not always measured. Other mandatory criteria are: initiation of drug therapy or persistence of hypoglycemia and need for treatment longer than the first 10 days of life and up to the sixth month of life. This means that an euglycemic metabolic state (without drug therapy) is required from the sixth month of life. Diagnostic criteria for the "transient neonatal hypoglycaemia" are a persistent hypoglycaemia (<60 mg/dl) over the 72nd hour of life and <10 days. Diagnostic criteria of the “physiological neonatal hypoglycaemia” investigation group include a spontaneous normalization of low blood sugars levels within the first 3 days of life.
Exclusion criteria
Exclusion criteria: Prematurity <34th week of gestation; Other severe disease at birth (e.g. severe heart defect, complex or severe underlying disease), syndromic hyperinsulinism forms, which affect the neurological development independently of hypoglycaemia. Lack of consent from parents / patients. The patient data of patients with persistent or transient hyperinsulinism are collected from the patient files at hospitals and clinics in Germany. Data from the entire first year of life are examined. The data of the patients in the control groups "physiological neonatal hypoglycaemia" and "transitory neonatal hypoglycaemia" are collected exclusively at the University Hospital in Düsseldorf. The patient data derives from 01/2008 - 12/2018.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of patient management and reduction of neurological damage | — |
Secondary
| Measure | Time frame |
|---|---|
| Establishement of national guidelines for midwives and doctors in management of postnatal hypoglycemia | — |
Countries
Germany
Contacts
Public ContactThomas Meissner
Universitätsklinikum DüsseldorfKlinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie
Outcome results
None listed