Developmental-disabilities, blood-glucose, hypoglycaemia Pregnancy and Childbirth Neonatal disabilities
Conditions
Interventions
In the intensive treatment arm the aim is to increase the glucose concentration above 2.5 mmol/l within three hours by increasing the carbohydrate intake by oral nutrition and/or intravenous glucose a
Sponsors
Academic Medical Centre (AMC) (The Netherlands)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as 04/09/2019: Infants greater than or equal to 35 weeks gestational age and greater than or equal to 2000 g with one of the four major risk factors for neonatal hypoglycaemia: 1. Small-for-Gestational-Age infants (SGA, birth-weight-for-gestational-age less than P10) 2. Large-for-Gestational-Age infants (LGA, birth-weight-for-gestational-age greater than P90) 3. Near-term infants 35 0/7 to 36 6/7 weeks gestational age with a birth weight greater than 2000 g 4. Infants of Diabetic Mothers (IDM) Birth-weight-for-gestational-age is defined according to the growth charts of the Perinatale Registratie Nederland (PRN). Previous participant inclusion criteria: Infants greater than or equal to 35 weeks gestational age and greater than or equal to 2000 g with one of the four major risk factors for neonatal hypoglycaemia: 1. Small-for-Gestational-Age infants (SGA, birth-weight-for-gestational-age less than P10) 2. Large-for-Gestational-Age infants (LGA, birth-weight-for-gestational-age greater than P90) 3. Near-term infants 35 0/7 to 36 6/7 weeks gestational age with a birth weight greater than 2000 g 4. Infants of Diabetic Mothers (IDM) Birth-weight-for-gestational-age is defined according to the Kloosterman growth charts.
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria: Infants with serious co-morbidity will be excluded, because their co-morbidity can also affect neurodevelopment: 1. Very preterm infants (less than 34 6/7 weeks gestational age) 2. Severe perinatal asphyxia - presence of at least three of the next criteria: 2.1. Signs of intrauterine asphyxia, like late decelerations on Cardiotocogram (CTG) or meconium stained amniotic fluid 2.2. Arterial umbilical cord pH less than 7.10 2.3. Delayed initiation of spontaneous respirations greater than 5 minutes after birth 2.4. Five minute Apgar score less than 5 2.5. 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 Previous participant exclusion criteria: Infants with serious co-morbidity will be excluded, because their co-morbidity can also affect neurodevelopment: 1. Very preterm infants (less than 34 6/7 weeks gestational age) 2. Severe perinatal asphyxia - presence of at least three of the next criteria: 2.1. Signs of intrauterine asphyxia, like late decelerations on Cardiotocogram (CTG) or meconium stained amniotic fluid 2.2. Arterial umbilical cord pH less than 7.10 2.3. Delayed initiation of spontaneous respirations greater than 5 minutes after birth 2.4. Five minute Apgar score less than 5 2.5. 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. (Strong suspicion of) inborn error of metabolism 8. (Strong suspicion of) hyperinsulinism, except infants of diabetic mothers 9. 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 |
|---|---|
| Current secondary outcome measures as of 04/09/2019: 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 hypoglycaemic despite the treatment they received (frequency and severity of hypoglycaemia episodes after randomization). Previous secondary outcome measures: Secondary outcomes are costs for medical treatment and hospital admission until 18 months of age. | — |
Countries
Netherlands
Outcome results
None listed