Condition category
Neonatal Diseases
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
07/12/2015
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 Michael Thomson

ORCID ID

Contact details

Department of Paediatric Gastroenterology
Royal Free Hampstead NHS Trust
Pond Street
Hampstead
London
NW3 2QG
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0256124183

Study information

Scientific title

The influence of Neocate or cow's milk protein-based formula on acid and non-acid gastro-oesophageal reflux in infants

Acronym

Study hypothesis

Is Neocate a simple safe alternative to cow's milk protein-based formula for infants suspected of having gastro-oesophageal reflux associated oesophagitis?

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

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Neonatal Diseases: Gastro-oesophageal reflux associated oesophagitis

Intervention

Double blind study of Neocate versus cow's milk protein-based formula

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Service outcome development

Secondary outcome measures

Not provided at time of registration

Overall trial start date

29/04/2003

Overall trial end date

30/09/2003

Reason abandoned

Eligibility

Participant inclusion criteria

20 patients

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

20

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

29/04/2003

Recruitment end date

30/09/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Free Hampstead NHS Trust
London
NW3 2QG
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

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

Funders

Funder type

Hospital/treatment centre

Funder name

The Royal Free Hampstead NHS Trust (UK)

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

07/12/2015: no publications found on PubMed.