Condition category
Pregnancy and Childbirth
Date applied
11/05/2015
Date assigned
20/05/2015
Last edited
20/05/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Neonatal hypoglycaemia is the term used to describe low blood sugar levels in babies in the first few days after birth. Newborn babies with low blood sugar are usually treated with extra feedings (breast milk or formula); in some cases the baby will need to be fed a sugar solution using a drip. Treatment is carried out until the baby’s sugar levels become stable, which can take from hours to days, or even longer. In New Zealand, a new national guideline on treating neonatal hypoglycaemia using dextrose (sugar) gel has been developed. However, it is unclear who the best people are on the ward to put the new guideline in place: midwives or doctors. This is because newborns on postnatal wards are routinely cared for by midwives, while doctors are there to provide medical treatment for sick babies. The aim of this study is to see whether it is doctors or midwives that are best placed to implement a new guideline for changing clinical practice for babies on postnatal wards.

Who can participate?
New Zealand maternity hospitals with more than 50 births per year.

What does the study involve?
Participating hospitals are randomly allocated into one of two groups. Those in group 1 (intervention group) have a medical or midwifery leader appointed to implement a guideline on treating neonatal hypoglycaemia with dextrose gel. Those in group 2 (control group) continue to provide standard care on postnatal maternity wards. The change in the number of eligible hypoglycaemic babies treated with dextrose gel is compared from before the implementation of the guideline and then again three months afterwards.

What are the possible benefits and risks of participating?
Participation in the trial will help determine the most effective local leader to implement a guideline on the postnatal wards. The results will also potentially aid in the implementation of an effective neonatal treatment. There are no specific risks associated with participation in this study.

Where is the study run from?
University of Auckland (NZ)

When is the study starting and how long is it expected to run for?
May 2015 to May 2016

Who is funding the study?
Gravida: National Centre for Growth and Development (NZ)

Who is the main contact?
Dr J Alsweiler

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jane Alsweiler

ORCID ID

http://orcid.org/0000-0002-0874-6654

Contact details

University of Auckland
Private Bag 92019
Auckland
1142
New Zealand

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

U111-1167-9170

Study information

Scientific title

Local clinical leaders to implement a national guideline in babies on postnatal wards: a cluster-randomised, blinded, controlled trial

Acronym

Study hypothesis

Midwives are the most effective local leaders for implementing a guideline for use of oral dextrose gel to treat neonatal hypoglycaemia.

Ethics approval

New Zealand Northern A Health and Disabilities Ethics Committee, 19/03/2015, ref: 15/NTA/31.

Study design

Multi-centre cluster blinded randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Neonatal hypoglycaemia

Intervention

Participating hospitals will be randomised:
1. Intervention group will have a medical or midwifery leader to implement a guideline on oral dextrose gel to treat neonatal hypoglycaemia
2. Control group will deliver standard care

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

The change in the proportion of eligible hypoglycaemic babies, treated with dextrose gel before implementation of the dextrose gel guideline, to three months after implementation.

Secondary outcome measures

1. Proportion of eligible babies admitted to NICU for at least four hours
2. Proportion of eligible babies given formula as a treatment for hypoglycaemia during hospital admission
3. Amount of dextrose gel used in the hospital
4. Initial uptake of dextrose gel (change in proportion of eligible babies treated with dextrose gel before implementation of the guideline to one month after implementation)
5. Sustained use of dextrose gel (change in proportion of eligible babies treated with dextrose gel from one month after implementation to three months after implementation)
6. Successful treatment with oral dextrose gel on the blood test taken immediately following dextrose gel treatment
7. Adherence to the 'oral dextrose gel to treat neonatal hypoglycaemia guideline'
8. Breast feeding at discharge

Overall trial start date

01/05/2015

Overall trial end date

01/05/2016

Reason abandoned

Eligibility

Participant inclusion criteria

Doctors and midwives attached to New Zealand maternity hospitals with >50 births/year where babies are at risk of neonatal hypoglycaemia (infant of a diabetic, late preterm, small or large for gestational age) are delivered, including hospitals where oral dextrose gel is currently in use.

Participant type

Mixed

Age group

Mixed

Gender

Both

Target number of participants

34 hospitals and approximately 1250 babies born during the study period

Participant exclusion criteria

Hospitals in NZ without a doctor (paediatrician or general practitioner) available to provide medical treatment, or no midwifery care for newborn babies.

Recruitment start date

01/06/2015

Recruitment end date

01/12/2015

Locations

Countries of recruitment

New Zealand

Trial participating centre

University of Auckland
Auckland
1010
New Zealand

Sponsor information

Organisation

University of Auckland

Sponsor details

Private Bag 92019
Auckland
1142
New Zealand

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

Gravida: National Centre for Growth and Development (NZ)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We intend to publish the results of our study via a number of avenues including submitting an article to a peer-reviewed scientific journal, conference presentations and website publication by the end of 2016.

Intention to publish date

01/12/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes