Condition category
Neonatal Diseases
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
08/04/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr James Devlin

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0084144605

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

05/04/2004

Overall trial end date

04/04/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Neonate

Gender

Not Specified

Target number of participants

Convenience sampling will be used to accrue a minimum sample size of 20 neonates.

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

05/04/2004

Recruitment end date

04/04/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Northern Lincolnshire & Goole Hospitals NHS Trust
Scunthorpe
DN15 7BH
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Northern Lincolnshire and Goole Hospitals NHS Trust (UK), NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes