Infant, Newborn, DiseasesPhase 2/3DIMOHNNCT00994149
Diazoxide In the Management Of Hypoglycemic Neonates
A Phase 2/3 study testing Diazoxide and Ora-plus in people with Infant, Newborn, Diseases and Pregnancy in Diabetics, run by University of Saskatchewan at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 12 hours
- Conditions the study is for
- Infant, Newborn, Diseases, Pregnancy in Diabetics, Infant, Diabetic Mother
- What is being tested?
- Diazoxide and Ora-plus
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2009to Oct 2011
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W4
Koravangattu Sankaran, MD, FRCPC, 1-306-966-8118, k.sankaran@usask.ca
Carmen Dmytryshyn, RN, 1-306-966-8138
About this study
Official title: Use for Diazoxide in the Initial Management of Hypoglycemia in Infants of Diabetic Mothers and Infants Large for Gestation
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.
- Conditions
- Infant, Newborn, Diseases, Pregnancy in Diabetics, Infant, Diabetic Mother, Hypoglycemia, Infant, Large for Gestational Age
- Being tested
- Diazoxide, Ora-plus
- Keywords
- Infants of Diabetic Mothers, Hypoglycemia, Diazoxide, Large for Gestation Infants
- Medical subject headings
- Infant, Newborn, Diseases, Pregnancy in Diabetics, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiazoxideDrug
Also called Brand Name: Proglycem
10mg/kg/d divide every 8 hours
Ora-plusDrug
placebo, give every 8 hours.
| Study group | Role | What they receive |
|---|---|---|
| Diazoxide | Experimental | Infants in this are will receive 10mg/kg/d of diazoxide divided and given every eight hours Receives: Drug: Diazoxide |
| Ora-plus | Placebo comparator | Liquid suspension modified to match intervention. Given every eight hours. Provided in shielded syringes. Receives: Drug: Ora-plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose measurement less than 2.0mmol/L
Measured: 14 days
Secondary outcomes (6)
Number of infants with significantly low blood glucose measurements (<1.5mmol/L).
Measured: 14 days
Length of stay for infants in hospital
Measured: 14 days
Need for intravenous dextrose infusion to maintain blood glucose above 2.0mmol/L
Measured: 14 days
Admission to neonatal intensive care unit (NICU)
Measured: 14 days
Thrombocytopenia and/or Leukopenia
Measured: 14 days
Electrolyte imbalance requiring clinical intervention (intravenous or oral)
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionOct 2011 (estimated)
- Study completionOct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Infant, Newborn, DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Investigators
- Koravangattu Sankaran, MD, BS, FRCPC, F.C.C.M., Principal investigator, University of Saskatchewan, Department of Pediatrics, Head of Neonatal Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00994149
- Sponsor's protocol ID
- Bio-REB #08-151
- Other IDs
- HC Control Number: 126963
- Acronym
- DIMOHN
- Status last verified
- Oct 2009
- First submitted
- 30 Sep 2009
- Last updated
- 14 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19688086Stenninger 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.
PubMed 10194986Holtrop 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.
PubMed 8476480Cornblath 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.
PubMed 10790476Diwakar 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.
PubMed 12091291Hoseth 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.
PubMed 10952705Hawdon JM. Hypoglycaemia and the neonatal brain. Eur J Pediatr. 1999 Dec;158 Suppl 1:S9-S12. doi: 10.1007/pl00014319.
PubMed 10592092Stenninger 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.
PubMed 9475319Nold 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.
PubMed 15157588DRASH 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.
PubMed 14193979Agrawal 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.
PubMed 10940170Tyrrell 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.
PubMed 11885714Touati 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.
PubMed 9727845Dunne 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.
PubMed 14715916Shirland 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.
PubMed 12143902
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use for Diazoxide in the Initial Management of Hypoglycemia in Infants of Diabetic Mothers and Infants Large for Gestation
- ClinicalTrials.gov ID
- NCT00994149
- Acronym / sponsor ID
- DIMOHN / Bio-REB #08-151
- Conditions
- Infant, Newborn, Diseases, Pregnancy in Diabetics, Infant, Diabetic Mother, Hypoglycemia, Infant, Large for Gestational Age
- Keywords
- Infants of Diabetic Mothers, Hypoglycemia, Diazoxide, Large for Gestation Infants
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Oct 2011 (estimated)
- First posted
- 14 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diazoxide | Experimental | Drug: DiazoxideInfants in this are will receive 10mg/kg/d of diazoxide divided and given every eight hours |
| Ora-plus | Placebo comparator | Drug: Ora-plusLiquid suspension modified to match intervention. Given every eight hours. Provided in shielded syringes. |
Who may qualify
- Ages
- Up to 12 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiazoxideAlso: Brand Name: Proglycem10mg/kg/d divide every 8 hours | Drug | Diazoxide |
| Ora-plusplacebo, give every 8 hours. | Drug | Ora-plus |
Primary outcome
Blood glucose measurement less than 2.0mmol/L
Time frame: 14 days
6 secondary outcomes
Number of infants with significantly low blood glucose measurements (<1.5mmol/L).
Time frame: 14 days
Length of stay for infants in hospital
Time frame: 14 days
Need for intravenous dextrose infusion to maintain blood glucose above 2.0mmol/L
Time frame: 14 days
Admission to neonatal intensive care unit (NICU)
Time frame: 14 days
Thrombocytopenia and/or Leukopenia
Time frame: 14 days
Electrolyte imbalance requiring clinical intervention (intravenous or oral)
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2009.
- Background: PubMed 19688086Screening 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.
- Background: PubMed 10194986Stenninger 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.
- Background: PubMed 8476480Holtrop 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.
- Background: PubMed 10790476Cornblath 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.
- Background: PubMed 12091291Diwakar 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.
- Background: PubMed 10952705Hoseth 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.
- Background: PubMed 10592092Hawdon JM. Hypoglycaemia and the neonatal brain. Eur J Pediatr. 1999 Dec;158 Suppl 1:S9-S12. doi: 10.1007/pl00014319.
- Background: PubMed 9475319Stenninger 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.
- Background: PubMed 15157588Nold 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.
- Background: PubMed 14193979DRASH 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.
- Background: PubMed 10940170Agrawal 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.
- Background: PubMed 11885714Tyrrell 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Koravangattu Sankaran, MD, BS, FRCPC, F.C.C.M. principal investigator
University of Saskatchewan, Department of Pediatrics, Head of Neonatal Research Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Diazoxide and Ora-plus in people with Infant, Newborn, Diseases and Pregnancy in Diabetics, run by University of Saskatchewan at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Koravangattu Sankaran, MD, BS, FRCPC, F.C.C.M. (1-306-966-8118, k.sankaran@usask.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood glucose measurement less than 2.0mmol/L (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00994149, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2009.