eurodevelopmental outcome after neonatal hypoglycaemia: a multi-centre randomised controlled trial comparing intensive treatment versus expectant glucose monitoring in 'high risk' newborns

Not Applicable

Completed

• Conditions: Developmental-disabilities, blood-glucose, hypoglycaemia; Pregnancy and Childbirth; Neonatal disabilities

• Registration Number: ISRCTN79705768
• Lead Sponsor: Academic Medical Centre (AMC) (The Netherlands)

Brief Summary

2020 results in https://www.ncbi.nlm.nih.gov/pubmed/32023373 (added 06/02/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-08-23
• Study Completion: 2013-04-01
• Last Update Posted: 24 February 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 689

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

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

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.