Implementation of a guideline in babies on postnatal wards
| ISRCTN | ISRCTN61154098 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61154098 |
| Secondary identifying numbers | U111-1167-9170 |
- Submission date
- 11/05/2015
- Registration date
- 20/05/2015
- Last edited
- 29/09/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
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. Hospitals in group 1 have a medical leader appointed to implement a guideline on treating neonatal hypoglycaemia with dextrose gel. Hospitals in group 2 have a midwifery leader appointed to implement a guideline on treating neonatal hypoglycaemia with dextrose gel. 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 3 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 March 2018
Who is funding the study?
Gravida: National Centre for Growth and Development (NZ)
Who is the main contact?
Dr J Alsweiler
Contact information
Scientific
University of Auckland
Private Bag 92019
Auckland
1142
New Zealand
 ORCID ID |
0000-0002-0874-6654 |
|---|
Study information
| Study design | Multi-centre cluster blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Local clinical leaders to implement a national guideline in babies on postnatal wards: a cluster-randomised, blinded, controlled trial |
| Study objectives | Midwives are the most effective local leaders for implementing a guideline for use of oral dextrose gel to treat neonatal hypoglycaemia. |
| Ethics approval(s) | New Zealand Northern A Health and Disabilities Ethics Committee, 19/03/2015, ref: 15/NTA/31. |
| Health condition(s) or problem(s) studied | Neonatal hypoglycaemia |
| Intervention | Current interventions as of 01/02/2022: Participating hospitals will be randomised: 1. Medical leader to implement a guideline on oral dextrose gel to treat neonatal hypoglycaemia 2. Midwifery leader to implement a guideline on oral dextrose gel to treat neonatal hypoglycaemia Previous interventions: 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 |
| Primary outcome measure | 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 | Current secondary outcome measures as of 01/02/2022: 1. Proportion of eligible babies admitted to NICU for at least 4 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. Prolonged uptake of dextrose gel (change in proportion of eligible babies treated with dextrose gel before implementation of the guideline to 6 months after implementation) 5. Sustained use of dextrose gel (change in proportion of eligible babies treated with dextrose gel from 3 months after implementation to 6 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. Breastfeeding at discharge Previous secondary outcome measures: 1. Proportion of eligible babies admitted to NICU for at least 4 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 1 month after implementation) 5. Sustained use of dextrose gel (change in proportion of eligible babies treated with dextrose gel from 1 month after implementation to 3 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. Breastfeeding at discharge |
| Overall study start date | 01/05/2015 |
| Completion date | 31/03/2019 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 34 hospitals and approximately 1250 babies born during the study period |
| Total final enrolment | 463 |
| Key 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. |
| Key exclusion criteria | Hospitals in NZ without a doctor (paediatrician or general practitioner) available to provide medical treatment, or no midwifery care for newborn babies. |
| Date of first enrolment | 01/06/2015 |
| Date of final enrolment | 13/06/2018 |
Locations
Countries of recruitment
- New Zealand
Study participating centre
1010
New Zealand
Sponsor information
University/education
Private Bag 92019
Auckland
1142
New Zealand
"ROR" |
https://ror.org/03b94tp07 |
|---|
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 31/03/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication 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. |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 22/11/2017 | 17/12/2020 | Yes | No |
| Results article | 28/09/2023 | 29/09/2023 | Yes | No |
Editorial Notes
29/09/2023: Publication reference added.
02/02/2022: Total final enrolment added.
01/02/2022: The interventions, secondary outcome measures and Plain English summary were updated.
17/12/2020: Publication reference added.
05/10/2018: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/08/2017 to 13/06/2018.
2. The overall trial end date was changed from 31/03/2018 to 31/03/2019.
3. The intention to publish date was changed from 31/03/2018 to 31/03/2019.
11/04/2017: The recruitment end date has been updated from 01/12/2015 to 31/08/2017 and the publication and dissemination plan has been added.
10/04/2017: The overall trial end date has been updated from 01/05/2016 to 31/03/2018.
