Skip to content

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

NEURODEVELOPMENTAL OUTCOME AFTER NEONATAL HYPOGLYCEMIA: A MULTI-CENTER RANDOMIZED CONTROLLED TRIAL COMPARING INTENSIVE TREATMENT VERSUS EXPECTANT GLUCOSE MONITORING IN 'HIGH RISK' NEWBORNS. - HYPO EXIT: HYPOglycemia: EXpectant versus Intensive Therapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON30992
Enrollment
800
Registered
2007-07-16
Start date
2007-05-01
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

neonatal hypoglycemia

Interventions

Intervention: In the intensive treatment arm the aim is to increase the glucose concentration above 2.5 mmol/l within 3 hours by increasing the carbohydrate intake by oral nutrition and/or intraveno

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
2 Years to 11 Years

Inclusion criteria

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 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

Exclusion criteria: Infants with serious co-morbidity will be excluded, because their co-morbidity can also affect neurodevelopment: 1. Very preterm infants (

Design outcomes

Primary

MeasureTime frame
Primary outcome is neurodevelopment at 18 months.

Secondary

MeasureTime frame
Secondary outcomes are costs for medical treatment and hospital admission until 18 months of age.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)