eurodevelopmental outcome after neonatal hypoglycemia: a multi-center randomized controlled trial comparing intensive treatment versus expectant glucose monitoring in 'high risk' newborns.
- Conditions
- Key words: HypoglycemiaBlood-glucoseInfant-newbornChild-developmentDevelopmental-disabilitiesRandomized-controlled-trialMulti-center-studies.Trefwoorden: Hypoglycemiebloedglucosepasgeborenepsychomotere ontwikkeling
- Registration Number
- NL-OMON23239
- Lead Sponsor
- Academical Medical Center, Amsterdam, The Netherlands
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 800
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).
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;
5. Severe hypotension requiring vasopressor support;
6. (Strong suspicion of) a syndrome or major congenital malformations.
Other exclusion criteria:
7. Intravenous glucose administration before randomization;
8. (Strong suspicion of) inborn error of metabolism;
9. (Strong suspicion of) hyperinsulinism, except infants of diabetic mothers;
10. No informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome is neurodevelopment at 18 months, assessed with the Bayley Scales of Infant Development.
- Secondary Outcome Measures
Name Time Method Secondary outcomes are:<br>1. Costs for medical treatment and hospital admission until 18 months of age:<br>1.1 costs for diagnostic tests and treatment of the infant (glucose measurements, supplemental feeding, tube-feeding, intravenous glucose administration), and hospitalization costs for both the infant and mother<br>1.2 costs for medical consumption related to neurodevelopmental impairment until the age of 18 months (visits to healthcare professionals and hospital admission after the neonatal period)<br>2. Plasma glucose concentrations and carbohydrate intake (breastfeeding, oral or enteral feeding and intravenous glucose)<br>3. Frequency of treatment failure, defined as infants who become severely hypoglycemic despite the treatment they received (frequency and severity of hypoglycemia episodes after randomization).