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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

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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Neonatal hypoglycaemia

Condition category

Condition code

Metabolic and Endocrine

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]

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]

Treatment failure defined as a blood glucose level < 2.6mM.

Timepoint [1]

30 minutes after the second of two treatment doses

Secondary outcome [1]

The time taken to achieve an interstitial glucose level above 2.6 mmol/l for >1 hour

Timepoint [1]

In the first 48 hours of life

Secondary outcome [2]

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]

In the first 48 hours after birth

Secondary outcome [3]

Total duration of interstitial glucose levels < 2.6 mmol/l

Timepoint [3]

In the first 48 hours after birth

Secondary outcome [4]

Incidence of admission to the neonatal intensive care unit for the management of neonatal hypoglycaemia

Timepoint [4]

In the first 48 hours after birth

Secondary outcome [5]

Frequency and total volume of formula administered in the first 48 hours

Timepoint [5]

In the first 48 hours after birth

Secondary outcome [6]

Frequency and total volume of expressed breast milk administered in the first 48 hours

Timepoint [6]

In the first 48 hours after birth

Secondary outcome [7]

Total dose of dextrose gel administered

Timepoint [7]

In the first 48 hours after birth

Secondary outcome [8]

Incidence and total dose of intravenous dextrose administered in the first 48 hours

Timepoint [8]

In the first 48 hours after birth

Secondary outcome [9]

Rate of full breast feeding at two weeks of age

Timepoint [9]

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]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Auckland Medical Research Foundation

Address [1]

P.O. Box 110-139
Auckland 1148

Country [1]

New Zealand

Primary sponsor type

University

Name

University of Auckland

Address

Private Bag 92019
Auckland 1142

Country

New Zealand

Secondary sponsor category [1]

Hospital

Name [1]

Waikato District Health Board

Address [1]

Waikato Hospital
Private Bag 3200
Hamilton 3204

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern Y Regional Ethics Committee

Ethics committee address [1]

Ministry of Health
P.O. Box 1031
Hamilton 3204

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

Approval date [1]

08/05/2008

Ethics approval number [1]

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

Prof Jane E Harding

Address

Deputy Vice Chancellor (Reserach) Professor of Neonatology University of Auckland Private Bag 92019 Auckland 1142

Country

New Zealand

Phone

+6493737599 ext 85872

Fax

+6493737407

Email

j.harding@auckland.ac.nz

Contact person for public queries

Name

Professor Jane E Harding

Address

Deputy Vice Chancellor (Reserach)
Professor of Neonatology
University of Auckland
Private Bag 92019
Auckland

Country

New Zealand

Phone

+6493737599 ext 85872

Fax

+6493737407

Email

j.harding@auckland.ac.nz

Contact person for scientific queries

Name

Professor Jane E Harding

Address

University of Auckland
Private Bag 92019
Auckland 1142

Country

New Zealand

Phone

+6493737599 ext 85872

Fax

+6493737407

Email

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

Source	Title	Year of Publication	DOI
Embase	Lactate, rather than ketones, may provide alternative cerebral fuel in hypoglycaemic newborns.	2015	https://dx.doi.org/10.1136/archdischild-2014-306435
Embase	Outcome at 2 Years after Dextrose Gel Treatment for Neonatal Hypoglycemia: Follow-Up of a Randomized Trial.	2016	https://dx.doi.org/10.1016/j.jpeds.2015.10.066
Embase	Dextrose gel treatment does not impair subsequent feeding.	2017	https://dx.doi.org/10.1136/archdischild-2017-312772
Embase	What Happens to Blood Glucose Concentrations After Oral Treatment for Neonatal Hypoglycemia?.	2017	https://dx.doi.org/10.1016/j.jpeds.2017.06.034
Embase	Cost Analysis of Treating Neonatal Hypoglycemia with Dextrose Gel.	2018	https://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.