EURODEVELOPMENTAL OUTCOME AFTER NEONATAL HYPOGLYCEMIA: A MULTI-CENTER RANDOMIZED CONTROLLED TRIAL COMPARING INTENSIVE TREATMENT VERSUS EXPECTANT GLUCOSE MONITORING IN 'HIGH RISK' NEWBORNS.

• Conditions: neonatal hypoglycemia; low blood sugar concentration; 10018424; 10028920

• Registration Number: NL-OMON30992
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 800

Inclusion Criteria

Infants with one of the four major risk factors for neonatal hypoglycemia, who are routinely screened for neonatal hypoglycemia in current clinical practice:
1. Small-for-gestational-age infants (SGA, birth-weight-for-gestational-age 2. Large-for-gestational-age infants (LGA, birth-weight-for-gestational-age >P90);
3. Near-term infants 35 0/7 to 36 6/7 weeks gestational age with a birth weight >2000 gram;
4. Infants of diabetic mothers (IDM).
Birth-weight-for-gestational-age is defined according to the Kloosterman growth charts.

Exclusion Criteria

Infants with serious co-morbidity will be excluded, because their co-morbidity can also affect neurodevelopment:
1. Very preterm infants (<34 6/7 weeks gestational age)
2. Severe perinatal asphyxia
3. Severe perinatal infection
4. Respiratory insufficiency
5. Severe hypotension
6. (Strong suspicion of) a syndrome or major congenital malformations;Other exclusion criteria:
7. (Strong suspicion of) inborn error of metabolism
8. (Strong suspicion of) hyperinsulinism, except infants of diabetic mothers
9. No informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome is neurodevelopment at 18 months. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are costs for medical treatment and hospital admission until<br /><br>18 months of age. </p><br>