NCT00994149

Brief Summary

Diazoxide is an oral hyperglycemic medication. Diazoxide has been proven effective for treating hypoglycemia in infants and children with some types of persistent hyperinsulinemic hypoglycemia. The mechanism of action results in decreased insulin secretion. One of the causes of hypoglycemia in infants of diabetic mothers occurs due to a transient hyperinsulinemic state postnatally. The investigators have clinical experience and success using diazoxide in their unit for patients with hypoglycemia not adequately managed with intravenous (iv) dextrose and enteral supplementation. In this randomized controlled study the investigators expect that by using diazoxide as the initial treatment for infants of diabetic mothers with asymptomatic hypoglycemia (blood glucose of 2.5 to 2.0mmol/L), the investigators will be able to decrease the number of infants requiring an intravenous by at least thirty percent.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2009

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 14, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

October 14, 2009

Status Verified

October 1, 2009

Enrollment Period

2 years

First QC Date

September 30, 2009

Last Update Submit

October 10, 2009

Conditions

Infant, Newborn, DiseasesPregnancy in DiabeticsInfant, Diabetic MotherHypoglycemiaInfant, Large for Gestational Age

Keywords

Infants of Diabetic MothersHypoglycemiaDiazoxideLarge for Gestation Infants

Outcome Measures

Primary Outcomes (1)

  • Blood glucose measurement less than 2.0mmol/L

    14 days

Secondary Outcomes (6)

  • Number of infants with significantly low blood glucose measurements (<1.5mmol/L).

    14 days

  • Length of stay for infants in hospital

    14 days

  • Need for intravenous dextrose infusion to maintain blood glucose above 2.0mmol/L

    14 days

  • Admission to neonatal intensive care unit (NICU)

    14 days

  • Thrombocytopenia and/or Leukopenia

    14 days

  • +1 more secondary outcomes

Study Arms (2)

Diazoxide

EXPERIMENTAL

Infants in this are will receive 10mg/kg/d of diazoxide divided and given every eight hours

Drug: Diazoxide

Ora-plus

PLACEBO COMPARATOR

Liquid suspension modified to match intervention. Given every eight hours. Provided in shielded syringes.

Drug: Ora-plus

Interventions

DiazoxideDRUG

10mg/kg/d divide every 8 hours

Also known as: Brand Name: Proglycem
Diazoxide
Ora-plusDRUG

placebo, give every 8 hours.

Ora-plus

Eligibility Criteria

AgeUp to 12 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infants of diabetic mothers (IDMs) or infants weighing \>90%
  • Hypoglycemia: two consecutive blood glucose measurements \<2.6mol/L and \>1.9mmol/L in the first twelve hours of life
  • \> 36 weeks gestational age

You may not qualify if:

  • Infants with symptomatic hypoglycemia (regardless of value
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W4, Canada

Location

Related Publications (18)

  • 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.

    PMID: 19688086BACKGROUND

  • 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.

    PMID: 10194986BACKGROUND

  • 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.

    PMID: 8476480BACKGROUND

  • 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.

    PMID: 10790476BACKGROUND

  • 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.

    PMID: 12091291BACKGROUND

  • 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.

    PMID: 10952705BACKGROUND

  • Hawdon JM. Hypoglycaemia and the neonatal brain. Eur J Pediatr. 1999 Dec;158 Suppl 1:S9-S12. doi: 10.1007/pl00014319.

    PMID: 10592092BACKGROUND

  • 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.

    PMID: 9475319BACKGROUND

  • 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.

    PMID: 15157588BACKGROUND

  • 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.

    PMID: 14193979BACKGROUND

  • 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.

    PMID: 10940170BACKGROUND

  • 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.

    PMID: 11885714BACKGROUND

  • 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.

    PMID: 9727845BACKGROUND

  • 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.

    PMID: 14715916BACKGROUND

  • 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.

    PMID: 12143902BACKGROUND

  • Taketomo CK, Hodding JH, Kraus DM. Pediatric Dosage Handbook 14th edition. Hudson (OH): Lexi-comp, Inc. 2007: 485-6

    BACKGROUND

  • 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.

    PMID: 3970573BACKGROUND

  • Behrman RE, Kliegman R, Jenson HB, StantonBF. Nelson Textbook of Pediatrics 18th Edition. Philadelphia: WB Saunders Company 2007:783-6

    BACKGROUND

MeSH Terms

Conditions

Infant, Newborn, DiseasesPregnancy in DiabeticsHypoglycemia

Interventions

Diazoxide

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and AbnormalitiesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

BenzothiadiazinesSulfonamidesSulfonesSulfur CompoundsOrganic ChemicalsThiazidesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Koravangattu Sankaran, MD, BS, FRCPC, F.C.C.M.

    University of Saskatchewan, Department of Pediatrics, Head of Neonatal Research Group

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Koravangattu Sankaran, MD, BS, FRCPC, F.C.C.M.

CONTACT

1-306-966-8118k.sankaran@usask.ca

Jennifer M Toye, MD, FRCP(C)

CONTACT

1-306-966-8118jtoye13@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 30, 2009

First Posted

October 14, 2009

Study Start

October 1, 2009

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

October 14, 2009

Record last verified: 2009-10

Locations

CA(1)