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
Protocol serial number	N0084144605
Sponsor	Department of Health
Funder	Northern Lincolnshire and Goole Hospitals NHS Trust (UK), NHS R&D Support Funding

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

Dr James Devlin
Scientific

Northern Lincolnshire & Goole Hospitals NHS Trust
Scunthorpe General Hospital
Cliff Gardens
Scunthorpe
DN15 7BH
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	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.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	04/04/2005

Participant type(s)	Patient
Age group	Neonate
Sex	Not Specified
Target sample size at registration	20
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

Northern Lincolnshire & Goole Hospitals NHS Trust

Scunthorpe
DN15 7BH
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan