Key words: Hypoglycemia
Conditions
Interventions
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 intravenous glucose admin
Sponsors
Academical Medical Center, Amsterdam, The Netherlands
Eligibility
Inclusion 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 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
Exclusion criteria: Infants with serious co-morbidity will be excluded, because their co-morbidity can also affect neurodevelopment: 1. Very preterm infants (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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome is neurodevelopment at 18 months, assessed with the Bayley Scales of Infant Development. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are: 1. Costs for medical treatment and hospital admission until 18 months of age: 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 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) 2. Plasma glucose concentrations and carbohydrate intake (breastfeeding, oral or enteral feeding and intravenous glucose) 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). | — |
Contacts
Public ContactAnne van Kempen
Dept. of Pediatrics, OLVG Hospital, Amsterdam
Outcome results
None listed