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
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