A prospective, randomised pilot study in the management of neonates at risk of hypoglycaemia (34 weeks to term) by oral feeding using preterm formula.
| ISRCTN | ISRCTN13668937 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13668937 |
| Secondary identifying numbers | N0084144605 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 08/04/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr James Devlin
Scientific
Scientific
Northern Lincolnshire & Goole Hospitals NHS Trust
Scunthorpe General Hospital
Cliff Gardens
Scunthorpe
DN15 7BH
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | Preterm formula milk, having a higher calorie density than standard formula, is beneficial in maintaining blood glucose levels in neonates at high risk of hypoglycaemia. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Neonatal Diseases |
| Intervention | Randomisation of at least 10 in each arm, routine management of cannulation and intravenous glucose or oral feeding of Preterm formula. |
| Intervention type | Other |
| Primary outcome measure | The two groups are compared using independent t-tests. So calculating means or proportions per group with 95% Cls for the difference between means or proportions as appropriate. If there is an element of repeated measures (i.e. if measuring each person more than once) then calculate the area under the curve (AUC) for each group and then compare the AUCs for binary categorical data odds ratios again with 95% CIs, can be used. Somewhere, an arbitrary level of 5% significance (two-tailed) will be assumed. Randomisation will be according to a random numbers table. Even split can not be done with a small sample. Due to small sample, the method of minimisation may be used, when randomising, or randomise using blocks. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 05/04/2004 |
| Completion date | 04/04/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Not Specified |
| Target number of participants | Convenience sampling will be used to accrue a minimum sample size of 20 neonates. |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 05/04/2004 |
| Date of final enrolment | 04/04/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Northern Lincolnshire & Goole Hospitals NHS Trust
Scunthorpe
DN15 7BH
United Kingdom
DN15 7BH
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Northern Lincolnshire and Goole Hospitals NHS Trust (UK), NHS R&D Support Funding
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
