Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000270516
Ethics application status
Approved
Date submitted
21/04/2005
Date registered
21/04/2005
Date last updated
5/11/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
High blood sugar levels and insulin treatment in preterm babies. The HINT trial.
Scientific title
Randomised controlled trial on the effect of tight glycaemic control with insulin in hyperglycaemic very low birth weight (VLBW) preterm neonates on growth.
Secondary ID [1] 63 0
Perinatal Trials Registry: PTR544
Universal Trial Number (UTN)
Trial acronym
HINT trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neonatal Hyperglycaemia 59 0
Condition category
Condition code
Reproductive Health and Childbirth 69 69 0 0
Complications of newborn
Blood 70 70 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Continuous intravenous insulin infusion starting at 0.05 units/kg.hour, titrated to maintain target blood glucose levels. In the intervention group insulin will be started in hyperglycaemic babies after two concecutive blood glucose levels of > 8.5 mmol/l, 4 hours apart. The insulin will be titrated to maintain the blood glucose level from 4-6 mmol/l.
Intervention code [1] 1106 0
Treatment: Drugs
Comparator / control treatment
n the control group insulin will only be started in hyperglycaemic babies who are over 3 days old, and have persistently elevated blood gluocose levels > 10 mmol/l, and unable to tolerate 100 cal/kg.day. Once insuin is started the dose will be titrated to maintain the blood glucose level 8-10 mmol/l. The trial will continue until 36 weeks post menstrual age.
Control group
Active

Outcomes
Primary outcome [1] 99 0
Lower leg growth rate
Timepoint [1] 99 0
Twice a week until 36 weeks post menstrual age
Secondary outcome [1] 196 0
1. Number of episodes of sepsis
Timepoint [1] 196 0
Until 36 weeks post menstrual age.
Secondary outcome [2] 197 0
2. Need for and number of blood transfusions
Timepoint [2] 197 0
Until 36 weeks post menstrual age.
Secondary outcome [3] 198 0
3. Myocardial hypertrophy
Timepoint [3] 198 0
At randomisation, 2 and 4 weeks post randomisation and 36 weeks post menstrual age.
Secondary outcome [4] 199 0
4. Cortisol level at randomisation and insulin like growth factor - 1 (IGF-1) + insulin levels.
Timepoint [4] 199 0
At randomisation, 7 and 14 days post randomisation and 36 weeks post menstrual age.
Secondary outcome [5] 200 0
5. Incidence of hypoglycaemia (blood glucose level < 2.6 mmol/l)
Timepoint [5] 200 0
Until 36 weeks post menstrual age.

Eligibility
Key inclusion criteria
Babies <30 weeks gestation or <1500g and 2 consecutive blood glucose measurements of >8.5 mmol/l, 4 hours apart.
Minimum age
Not stated
Maximum age
30 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Hyperglycemia secondary to an accidental overdose. Babies with major congenital malformation. Imminent death

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation, by gender and birth weight for gestational age ( > or < 10 th centile)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/07/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
88
Accrual to date
Final
Recruitment outside Australia
Country [1] 327 0
New Zealand
State/province [1] 327 0

Funding & Sponsors
Funding source category [1] 98 0
Charities/Societies/Foundations
Name [1] 98 0
Auckland Medical Research Foundation
Country [1] 98 0
New Zealand
Funding source category [2] 99 0
Charities/Societies/Foundations
Name [2] 99 0
Starship Foundation
Country [2] 99 0
New Zealand
Funding source category [3] 100 0
Charities/Societies/Foundations
Name [3] 100 0
Paykel Trust
Country [3] 100 0
New Zealand
Primary sponsor type
Individual
Name
Dr Jane Alsweiler
Address
Newborn Services, Level 9, Support Building, Auckland City Hospital, Private Bag 92024, Auckland 1023, New Zealand
Country
New Zealand
Secondary sponsor category [1] 75 0
Individual
Name [1] 75 0
Dr Frank Bloomfield,
Address [1] 75 0
Newborn Services, Level 9, Support Building, Auckland City Hospital, Private Bag 92024, Auckland, New Zealand
Country [1] 75 0
New Zealand
Secondary sponsor category [2] 76 0
Individual
Name [2] 76 0
Professor Jane Harding
Address [2] 76 0
Vice Chancellors Office, Old Government House, Symond St,
University of Auckland, Private Bag 92019, Auckland
Country [2] 76 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 670 0
Auckland City Hospital
Ethics committee address [1] 670 0
Ethics committee country [1] 670 0
New Zealand
Date submitted for ethics approval [1] 670 0
Approval date [1] 670 0
Ethics approval number [1] 670 0
NTX/05/06/054

Summary
Brief summary
Many very preterm and small babies develop high blood sugar levels in the first few days to weeks after birth. Recent studies in critically ill adults with high blood sugar levels have shown that treatment with insulin to keep blood sugar levels in the normal range improved survival and reduced complications, regardless of whether the patients were diabetic or not. However, we do not know if the same is true for preterm babies. The purpose of this study is therefore to find out if babies with high blood sugar levels do better if their blood sugar level is kept in the normal range (4-6 mmol/l) with insulin treatment compared with the current practice of aiming for a blood sugar level less than 10 mmol/l. This study is a pilot study to determine if treatment is feasible in the newborn and improves growth. If successful, this would lead to a multi centre trial to determine if this treatment decreases mortality or improves neurodevelopmental outcome at 2 years of age.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36168 0
Address 36168 0
Country 36168 0
Phone 36168 0
Fax 36168 0
Email 36168 0
Contact person for public queries
Name 10295 0
Dr Jane Alsweiler
Address 10295 0
Newborn Services
Level 9
Support Building
Auckland City Hospital
Park Road
Grafton Auckland
Country 10295 0
New Zealand
Phone 10295 0
+64 9 3797440 ext 25365
Fax 10295 0
+64 9 3072804
Email 10295 0
[email protected]
Contact person for scientific queries
Name 1223 0
Dr Jane Alsweiler
Address 1223 0
Newborn Services
Level 9, Support Building
Auckland City Hospital
Park Road
Grafton
Auckland
Country 1223 0
New Zealand
Phone 1223 0
+64 9 3797440 ext 25365
Fax 1223 0
+64 9 3072804
Email 1223 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA C-Peptide-Based Model of Pancreatic Insulin Secretion in Extremely Preterm Neonates in Intensive Care.2016https://dx.doi.org/10.1177/1932296815596175
EmbaseLong-Term Outcomes of Hyperglycemic Preterm Infants Randomized to Tight Glycemic Control.2018https://dx.doi.org/10.1016/j.jpeds.2017.09.081
EmbaseEffects of Neonatal Hyperglycemia on Retinopathy of Prematurity and Visual Outcomes at 7 Years of Age: A Matched Cohort Study.2020https://dx.doi.org/10.1016/j.jpeds.2020.04.059
N.B. These documents automatically identified may not have been verified by the study sponsor.