Prevention of cerebral lesions by improving the management of postnatal hypoglycemia and hyperinsulinism

Recruiting

• Conditions: P70.0; P70.1; P70.4; P70.8; P70.9; E16.1; Syndrome of infant of mother with gestational diabetes; Syndrome of infant of a diabetic mother; Other neonatal hypoglycaemia; Other transitory disorders of carbohydrate metabolism of fetus and newborn

• Registration Number: DRKS00021474
• Lead Sponsor: niversitätsklinikum Düsseldorf

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

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 <45 mg / dl (2.6mmol/l). Diagnostic criteria for persistent congenital hyperinsulinism are based on established diagnostic criteria, i.e. in the first year of life: a significantly high carbohydrate requirement of >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

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.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement of patient management and reduction of neurological damage

Secondary Outcome Measures

Name	Time	Method
Establishement of national guidelines for midwives and doctors in management of postnatal hypoglycemia