NL-OMON23239
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.
Academical Medical Center, Amsterdam, The Netherlands0 sites800 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Academical Medical Center, Amsterdam, The Netherlands
- Enrollment
- 800
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Boluyt N, Van Kempen AAMW, Offringa M. Neurodevelopment after neonatal hypoglycemia: a systematic review and design of an optimal future study. Pediatrics. 2006 Jun;117(6):2231-43
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Infants \>\=35 weeks gestational age and \>\=2000 gram with one of the four major risk factors for neonatal hypoglycemia:
- •a. Small\-for\-gestational\-age infants (SGA, birth\-weight\-for\-gestational\-age b. Large\-for\-gestational\-age infants (LGA, birth\-weight\-for\-gestational\-age \>P90\);
- •c. Near\-term infants 35 0/7 to 36 6/7 weeks gestational age with a birth weight \>2000 gram;
- •d. Infants of diabetic mothers (IDM).
- •Birth\-weight\-for\-gestational\-age is defined according to the growth charts of the Perinatale Registratie Nederland (PRN).
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: presence of at least 3 of the next criteria:
- •a. Signs of intrauterine asphyxia, like late decelerations on CTG or meconium stained amniotic fluid
- •b. Arterial umbilical cord pH \<7\.10
- •c. Delayed initiation of spontaneous respirations \>5 minutes after birth
- •d. 5 minute Apgar score \<5;
- •e. Multi\-organ failure;
- •3\. Severe perinatal infection: requiring support of vital functions (infants without clinical signs of infection who are treated with antibiotics because of suspected perinatal infection can be included);
- •4\. Respiratory insufficiency requiring respiratory support;
Outcomes
Primary Outcomes
Not specified
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