Skip to main content
MedPathMedPath Home
Clinical Trials/NL-OMON30992
NL-OMON30992
Not yet recruiting
Not Applicable

EURODEVELOPMENTAL 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

Academisch Medisch Centrum0 sites800 target enrollmentTBD
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditionsneonatal hypoglycemialow blood sugar concentration1001842410028920

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
neonatal hypoglycemia
Sponsor
Academisch Medisch Centrum
Enrollment
800
Status
Not yet recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Eligibility 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 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

Outcomes

Primary Outcomes

Not specified

Similar Trials

Completed
Not Applicable
eurodevelopmental outcome after neonatal hypoglycaemia: a multi-centre randomised controlled trial comparing intensive treatment versus expectant glucose monitoring in 'high risk' newbornsDevelopmental-disabilities, blood-glucose, hypoglycaemiaPregnancy and ChildbirthNeonatal disabilities
ISRCTN79705768Academic Medical Centre (AMC) (The Netherlands)689
Completed
Not Applicable
eurodevelopmental Outcome after Fetal Neonatal Alloimmune Thrombocytopeniaantibodies against platelets during pregnancy.Fetal neonatal alloimmune thrombocytopenia (FNAIT)100355341001684910012562
NL-OMON49430eids Universitair Medisch Centrum63
Completed
Not Applicable
eurodevelopmental outcome after neonatal hypoglycemia: a multi-center randomized controlled trial comparing intensive treatment versus expectant glucose monitoring in 'high risk' newborns.
NL-OMON23239Academical Medical Center, Amsterdam, The Netherlands800
Not yet recruiting
Not Applicable
eurodevelopmental outcomes by surgery in children operated for congenital heart disease in the neonatal period
KCT0009388Asan Medical Center40
Active, not recruiting
Phase 3
hPOD - Hypoglycaemia Prevention in newborns with Oral Dextroseeonatal HypoglycaemiaNeonatal HypoglycaemiaMetabolic and Endocrine - Other metabolic disordersReproductive Health and Childbirth - Complications of newborn
ACTRN12614001263684niversity of Auckland2,149