Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000623392
Ethics application status
Approved
Date submitted
1/10/2008
Date registered
8/12/2008
Date last updated
13/11/2018
Date data sharing statement initially provided
13/11/2018
Date results information initially provided
13/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Sugar Babies Study
Scientific title
In near-term or term babies who are hypoglycaemic (blood glucose level <2.6mM), is buccal adminstration of 40% dextrose gel (200mg/kg) more effective than placebo in achieving a blood glucose level > 2.6mM 30 minutes after the second of two doses ?
Secondary ID [1] 259673 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neonatal hypoglycaemia 3889 0
Condition category
Condition code
Metabolic and Endocrine 4091 4091 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Massage 40% dextrose gel (200mg/kg) into the buccal membrane to reverse neonatal hypoglycaemia. A maximum of six doses to be given in 48 hours
Intervention code [1] 3494 0
Treatment: Drugs
Comparator / control treatment
The placebo gel is an identical gel in appearance (Carboxymethyl cellulose 2%) The placebo gel will be massaged into the buccal membranes. A maximum of six doses to be given in 48 hours.
Control group
Placebo

Outcomes
Primary outcome [1] 4859 0
Treatment failure defined as a blood glucose level < 2.6mM.
Timepoint [1] 4859 0
30 minutes after the second of two treatment doses
Secondary outcome [1] 8411 0
The time taken to achieve an interstitial glucose level above 2.6 mmol/l for >1 hour
Timepoint [1] 8411 0
In the first 48 hours of life
Secondary outcome [2] 8412 0
Incidence of recurrent hypoglycaemia (blood or interstitial glucose concentration <2.6 mmol/l) after initial successful treatment (defined as blood or interstitial glucose concentration > 2.6 mmol/l for >1 hour after initial treatment).
Timepoint [2] 8412 0
In the first 48 hours after birth
Secondary outcome [3] 8413 0
Total duration of interstitial glucose levels < 2.6 mmol/l
Timepoint [3] 8413 0
In the first 48 hours after birth
Secondary outcome [4] 8414 0
Incidence of admission to the neonatal intensive care unit for the management of neonatal hypoglycaemia
Timepoint [4] 8414 0
In the first 48 hours after birth
Secondary outcome [5] 8415 0
Frequency and total volume of formula administered in the first 48 hours
Timepoint [5] 8415 0
In the first 48 hours after birth
Secondary outcome [6] 8416 0
Frequency and total volume of expressed breast milk administered in the first 48 hours
Timepoint [6] 8416 0
In the first 48 hours after birth
Secondary outcome [7] 8417 0
Total dose of dextrose gel administered
Timepoint [7] 8417 0
In the first 48 hours after birth
Secondary outcome [8] 8418 0
Incidence and total dose of intravenous dextrose administered in the first 48 hours
Timepoint [8] 8418 0
In the first 48 hours after birth
Secondary outcome [9] 8419 0
Rate of full breast feeding at two weeks of age
Timepoint [9] 8419 0
At two weeks following birth

Eligibility
Key inclusion criteria
Babies at risk of hypoglycaemia will be recuited to the study. However, only babies who become hypoglycaemic (blood glucose level <2.6mM) will be randomised to treatment.
Minimum age
35 Weeks
Maximum age
45 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Serious congential malformations, Terminal conditions, Abnormalities of the skin or lesions that will prevent application of the continuous glucose monitor.

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)
Allocation is concealed and performed by central randomisation by a computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be done by computer randomisation using a balanced block design with a variable block size, and stratified by risk factors
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
10/11/2008
Actual
13/11/2008
Date of last participant enrolment
Anticipated
Actual
26/11/2010
Date of last data collection
Anticipated
30/11/2020
Actual
Sample size
Target
230
Accrual to date
Final
514
Recruitment outside Australia
Country [1] 1244 0
New Zealand
State/province [1] 1244 0

Funding & Sponsors
Funding source category [1] 4085 0
Charities/Societies/Foundations
Name [1] 4085 0
Auckland Medical Research Foundation
Country [1] 4085 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 3552 0
Hospital
Name [1] 3552 0
Waikato District Health Board
Address [1] 3552 0
Waikato Hospital
Private Bag 3200
Hamilton 3204
Country [1] 3552 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6031 0
Northern Y Regional Ethics Committee
Ethics committee address [1] 6031 0
Ministry of Health
P.O. Box 1031
Hamilton 3204
Ethics committee country [1] 6031 0
New Zealand
Date submitted for ethics approval [1] 6031 0
Approval date [1] 6031 0
08/05/2008
Ethics approval number [1] 6031 0
NTY/08/03/025

Summary
Brief summary
Background
Hypoglycaemia (low blood sugar) is the only common preventable cause of brain damage in babies. It is most common in the first twenty-four hours after birth, and is a common reason for admission to the Newborn Intensive Care Unit. Oral carbohydrate (sugar) is the first line of treatment of the conscious hypoglycaemic diabetic patient. However, oral treatment in babies has not been investigated. Waikato Hospital is the only hospital in Australasia to use 40% dextrose gel for treatment in babies. However, there is no evidence to support this practice. Furthermore, blood glucose levels are routinely measured intermittently. However blood glucose levels are known to fluctuate following birth and therefore periods of hypoglycaemia may be missed. We have developed experience with continuous glucose monitoring in the newborn.
Hypothesis
That 40% dextrose gel is more effective than feeding alone in reversing neonatal hypoglycaemia.
That intermittent blood glucose monitoring does not detect all episodes of hypoglycaemia.
Trial design
We propose a randomised, placebo controlled, double-blinded study in hypoglycaemic babies = 35 weeks gestation, comparing the incidence of treatment failure in babies randomised to receive either dextrose gel 40% or a placebo vehicle gel.
Method
Where possible babies = 35 weeks gestation who are at risk of hypoglycaemia will be enrolled prior to birth. Following birth a continuous glucose monitor will be applied, and remain in place for 48 hours. If during routine clinical blood tests hypoglycaemia is diagnosed, babies will be fed, and in addition will be randomised to receive either 40% dextrose gel or a placebo vehicle gel. The baby will receive up to two doses of gel 30 minutes apart. If hypoglycaemia persists, the baby will be admitted to the Newborn Intensive Care Unit for on-going care.
Outcomes
The primary outcome is treatment failure, defined as a blood glucose level < 2.6mM 30 minutes after the second of two treatment attempts.
Secondary outcomes include: time taken to achieve an interstitial glucose level >2.6mM for >1 hour; incidence of recurrent hypoglycaemia after an initial successful treatment; admission to the neonatal intensive care unit; frequency and total volume of formula administered in the first 48 hours; rate of full breast feeding at two weeks of age
Significance and expected benefits
Hypoglycaemia is very common in the newborn period. It is the most common cause of preventable brain damage in the newborn period. The diagnosis and management remain controversial. The majority of babies are admitted to the Newborn Intensive Care Unit for treatment. We hope to determine the effectiveness of an oral carbohydrate treatment regime that will reverse hypoglycaemia and allow the mother and baby to remain together. This may result in improving the rate of breast feeding and decrease hospital costs. In addition we aim to determine whether our current regime for intermittent blood glucose monitoring can be improved.
Trial website
Trial related presentations / publications
Harris, D. L., Weston, P. J., Signal, M., Chase, J. G., & Harding, J. E. (2013). Dextrose gel for neonatal hypoglycaemia (the Sugar Babies Study): a randomised, double-blind, placebo-controlled trial. The Lancet. 10.1016/S0140-6736(13)61645-1
Harris, D. L., Weston, P. J., & Harding, J. E. (2012). Incidence of neonatal hypoglycemia in babies identified as at risk. Journal of Pediatrics 161(5), 787-791. 10.1016/j.jpeds.2012.05.022
Public notes

Contacts
Principal investigator
Name 28996 0
Prof Jane E Harding
Address 28996 0
Deputy Vice Chancellor (Reserach) Professor of Neonatology University of Auckland Private Bag 92019 Auckland 1142
Country 28996 0
New Zealand
Phone 28996 0
+6493737599 ext 85872
Fax 28996 0
+6493737407
Email 28996 0
j.harding@auckland.ac.nz
Contact person for public queries
Name 12153 0
Professor Jane E Harding
Address 12153 0
Deputy Vice Chancellor (Reserach)
Professor of Neonatology
University of Auckland
Private Bag 92019
Auckland
Country 12153 0
New Zealand
Phone 12153 0
+6493737599 ext 85872
Fax 12153 0
+6493737407
Email 12153 0
j.harding@auckland.ac.nz
Contact person for scientific queries
Name 3081 0
Professor Jane E Harding
Address 3081 0
University of Auckland
Private Bag 92019
Auckland 1142
Country 3081 0
New Zealand
Phone 3081 0
+6493737599 ext 85872
Fax 3081 0
+6493737407
Email 3081 0
j.harding@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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
EmbaseLactate, rather than ketones, may provide alternative cerebral fuel in hypoglycaemic newborns.2015https://dx.doi.org/10.1136/archdischild-2014-306435
EmbaseOutcome at 2 Years after Dextrose Gel Treatment for Neonatal Hypoglycemia: Follow-Up of a Randomized Trial.2016https://dx.doi.org/10.1016/j.jpeds.2015.10.066
EmbaseDextrose gel treatment does not impair subsequent feeding.2017https://dx.doi.org/10.1136/archdischild-2017-312772
EmbaseWhat Happens to Blood Glucose Concentrations After Oral Treatment for Neonatal Hypoglycemia?.2017https://dx.doi.org/10.1016/j.jpeds.2017.06.034
EmbaseCost Analysis of Treating Neonatal Hypoglycemia with Dextrose Gel.2018https://dx.doi.org/10.1016/j.jpeds.2018.02.036
N.B. These documents automatically identified may not have been verified by the study sponsor.