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Neurodevelopmental outcome after neonatal hypoglycemia: a multi-center randomized controlled trial comparing intensive treatment versus expectant glucose monitoring in 'high risk' newborns.


- candidate number2654
- NTR NumberNTR1015
- ISRCTNISRCTN79705768
- Date ISRCTN created23-aug-2007
- date ISRCTN requested13-aug-2007
- Date Registered NTR3-jul-2007
- Secondary IDsZonMW Doelmatigheid 80-007022-98-07406 
- Public TitleNeurodevelopmental outcome after neonatal hypoglycemia: a multi-center randomized controlled trial comparing intensive treatment versus expectant glucose monitoring in 'high risk' newborns.
- Scientific TitleNeurodevelopmental outcome after neonatal hypoglycemia: a multi-center randomized controlled trial comparing intensive treatment versus expectant glucose monitoring in 'high risk' newborns.
- ACRONYMHYPO-EXIT
- hypothesisCurrent clinical practice varies widely, especially for infants with 'moderate' hypoglycemia, due to lack of methodological sound studies. This leads to both over- and under-treatment of hypoglycemic infants. This study-protocol is directed at the comparison of two accepted management strategies at both ends of the current treatment-spectrum of moderate hypoglycemia in 'high risk' newborns: an intensive treatment versus an expectant monitoring strategy.
- Healt Condition(s) or Problem(s) studiedRandomised study, Hypoglycemia, Blood glucose, Infant-newborn, Psychomotor development
- Inclusion criteria1. 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 Kloosterman growth charts.
- Exclusion criteriaInfants 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. (Strong suspicion of) inborn error of metabolism; 8. (Strong suspicion of) hyperinsulinism, except infants of diabetic mothers; 9. No informed consent.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-okt-2007
- planned closingdate1-okt-2010
- Target number of participants800
- InterventionsIn 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 administration. In the expectant arm the aim is to maintain the glucose concentration above 2.0 mmol/l by the usual oral nutrition protocol.
- Primary outcomePrimary outcome is neurodevelopment at 18 months, assessed with the Bayley Scales of Infant Development.
- Secondary outcomeSecondary outcomes are costs for medical treatment and hospital admission until 18 months of age.
- Timepoints
- Trial web sitehttp://www.studies-obsgyn.nl/hypoexit.nl
- statusplanned
- CONTACT FOR PUBLIC QUERIESResearch Coordinator Debbie Nuytemans
- CONTACT for SCIENTIFIC QUERIESMD, PhD Anne Kempen, van
- Sponsor/Initiator Academic Medical Center (AMC), Emma Children's Hospital
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsBoluyt 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
- Brief summaryRationale: Hypoglycemia is the most common metabolic problem in neonatology: around 25% of all newborns are at risk for neonatal hypoglycemia. In the Netherlands this means that around 40.000 newborns are at risk annually. Because hypoglycemia can lead to permanent brain damage, 'high risk' infants for hypoglycemia are admitted, screened and, if necessary, treated. However, there is still much controversy about the definition of a 'safe' plasma glucose concentration. Currently used limits for hypoglycemia vary between 2.0 and 2.6 mmol/l. As a result, current clinical practice varies widely, especially for infants with 'moderate' hypoglycemia (glucose 2.0-2.5 mmol/l). This leads to both over- and under-treatment of hypoglycemic infants. Objective: This study-protocol is directed at the comparison of two accepted management strategies at both ends of the current treatment-spectrum of moderate hypoglycemia in 'high risk' newborns: an intensive treatment versus an expectant monitoring strategy. Study design: Multi-center randomized controlled trial. Study population: 800 'high risk' newborn infants with moderate hypoglycemia >35 weeks gestational age and birth weight >2000 gram. Intervention: 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 administration. In the expectant arm the aim is to maintain the glucose concentration above 1.9 mmol/l by the usual oral nutrition protocol. Main study parameters/endpoints: Primary outcome is neurodevelopment at 18 months. Secondary outcomes are costs for medical treatment and hospital admission until 18 months of age.
- Main changes (audit trail)
- RECORD3-jul-2007 - 27-aug-2007


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