Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
100 participants
INTERVENTIONAL
2009-10-31
2011-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Diazoxide
Infants in this are will receive 10mg/kg/d of diazoxide divided and given every eight hours
Diazoxide
10mg/kg/d divide every 8 hours
Ora-plus
Liquid suspension modified to match intervention. Given every eight hours. Provided in shielded syringes.
Ora-plus
placebo, give every 8 hours.
Interventions
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Diazoxide
10mg/kg/d divide every 8 hours
Ora-plus
placebo, give every 8 hours.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Hypoglycemia: two consecutive blood glucose measurements \<2.6mol/L and \>1.9mmol/L in the first twelve hours of life
* \> 36 weeks gestational age
Exclusion Criteria
* Infants who meet criteria for intravenous dextrose according to the Canadian Pediatric Society (CPS) position statement
* Infants with contraindications for enteral feeds and/or medications
12 Hours
ALL
No
Sponsors
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University of Saskatchewan
OTHER
Responsible Party
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University of Saskatchewan, Department of Pediatrics, Neonatal Research Group
Principal Investigators
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Koravangattu Sankaran, MD, BS, FRCPC, F.C.C.M.
Role: PRINCIPAL_INVESTIGATOR
University of Saskatchewan, Department of Pediatrics, Head of Neonatal Research Group
Locations
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Royal University Hospital
Saskatoon, Saskatchewan, Canada
Countries
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Central Contacts
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Facility Contacts
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Carmen Dmytryshyn, RN
Role: backup
References
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Screening guidelines for newborns at risk for low blood glucose. Paediatr Child Health. 2004 Dec;9(10):723-740. doi: 10.1093/pch/9.10.723. No abstract available.
Stenninger E, Flink R, Eriksson B, Sahlen C. Long-term neurological dysfunction and neonatal hypoglycaemia after diabetic pregnancy. Arch Dis Child Fetal Neonatal Ed. 1998 Nov;79(3):F174-9. doi: 10.1136/fn.79.3.f174.
Holtrop PC. The frequency of hypoglycemia in full-term large and small for gestational age newborns. Am J Perinatol. 1993 Mar;10(2):150-4. doi: 10.1055/s-2007-994649.
Cornblath M, Hawdon JM, Williams AF, Aynsley-Green A, Ward-Platt MP, Schwartz R, Kalhan SC. Controversies regarding definition of neonatal hypoglycemia: suggested operational thresholds. Pediatrics. 2000 May;105(5):1141-5. doi: 10.1542/peds.105.5.1141.
Diwakar KK, Sasidhar MV. Plasma glucose levels in term infants who are appropriate size for gestation and exclusively breast fed. Arch Dis Child Fetal Neonatal Ed. 2002 Jul;87(1):F46-8. doi: 10.1136/fn.87.1.f46.
Hoseth E, Joergensen A, Ebbesen F, Moeller M. Blood glucose levels in a population of healthy, breast fed, term infants of appropriate size for gestational age. Arch Dis Child Fetal Neonatal Ed. 2000 Sep;83(2):F117-9. doi: 10.1136/fn.83.2.f117.
Hawdon JM. Hypoglycaemia and the neonatal brain. Eur J Pediatr. 1999 Dec;158 Suppl 1:S9-S12. doi: 10.1007/pl00014319.
Stenninger E, Schollin J, Aman J. Early postnatal hypoglycaemia in newborn infants of diabetic mothers. Acta Paediatr. 1997 Dec;86(12):1374-6. doi: 10.1111/j.1651-2227.1997.tb14916.x.
Nold JL, Georgieff MK. Infants of diabetic mothers. Pediatr Clin North Am. 2004 Jun;51(3):619-37, viii. doi: 10.1016/j.pcl.2004.01.003.
DRASH A, WOLFF F. DRUG THERAPY IN LEUCINE-SENSITIVE HYPOGLYCEMIA. Metabolism. 1964 Jun;13:487-92. doi: 10.1016/0026-0495(64)90133-7. No abstract available.
Agrawal RK, Lui K, Gupta JM. Neonatal hypoglycaemia in infants of diabetic mothers. J Paediatr Child Health. 2000 Aug;36(4):354-6. doi: 10.1046/j.1440-1754.2000.00512.x.
Tyrrell VJ, Ambler GR, Yeow WH, Cowell CT, Silink M. Ten years' experience of persistent hyperinsulinaemic hypoglycaemia of infancy. J Paediatr Child Health. 2001 Oct;37(5):483-8. doi: 10.1046/j.1440-1754.2001.00748.x.
Touati G, Poggi-Travert F, Ogier de Baulny H, Rahier J, Brunelle F, Nihoul-Fekete C, Czernichow P, Saudubray JM. Long-term treatment of persistent hyperinsulinaemic hypoglycaemia of infancy with diazoxide: a retrospective review of 77 cases and analysis of efficacy-predicting criteria. Eur J Pediatr. 1998 Aug;157(8):628-33. doi: 10.1007/s004310050900.
Dunne MJ, Cosgrove KE, Shepherd RM, Aynsley-Green A, Lindley KJ. Hyperinsulinism in infancy: from basic science to clinical disease. Physiol Rev. 2004 Jan;84(1):239-75. doi: 10.1152/physrev.00022.2003.
Shirland L. When it is more than transient neonatal hypoglycemia: hyperinsulinemia--a case study challenge. Neonatal Netw. 2001 Jun;20(4):5-11. doi: 10.1891/0730-0832.20.4.5.
Taketomo CK, Hodding JH, Kraus DM. Pediatric Dosage Handbook 14th edition. Hudson (OH): Lexi-comp, Inc. 2007: 485-6
McGraw ME, Price DA. Complications of diazoxide in the treatment of nesidioblastosis. Arch Dis Child. 1985 Jan;60(1):62-4. doi: 10.1136/adc.60.1.62.
Behrman RE, Kliegman R, Jenson HB, StantonBF. Nelson Textbook of Pediatrics 18th Edition. Philadelphia: WB Saunders Company 2007:783-6
Other Identifiers
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HC Control Number: 126963
Identifier Type: -
Identifier Source: secondary_id
Bio-REB #08-151
Identifier Type: -
Identifier Source: org_study_id
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