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

Academic Medical Centre (AMC) (The Netherlands)0 sites689 target enrollmentAugust 23, 2007

Overview

Registry

who.int

Start Date

August 23, 2007

End Date

April 1, 2013

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

Academic Medical Centre (AMC) (The Netherlands)

•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\)

•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)