The influence of Neocate or cow's milk protein-based formula on acid and non-acid gastro-oesophageal reflux in infants
| ISRCTN | ISRCTN33578711 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33578711 |
| Secondary identifying numbers | N0256124183 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 07/12/2015
- 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 Michael Thomson
Scientific
Scientific
Department of Paediatric Gastroenterology
Royal Free Hampstead NHS Trust
Pond Street
Hampstead
London
NW3 2QG
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 |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The influence of Neocate or cow's milk protein-based formula on acid and non-acid gastro-oesophageal reflux in infants |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Neonatal Diseases: Gastro-oesophageal reflux associated oesophagitis |
| Intervention | Double blind study of Neocate versus cow's milk protein-based formula |
| Intervention type | Other |
| Primary outcome measure | Service outcome development |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 29/04/2003 |
| Completion date | 30/09/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 20 |
| Key inclusion criteria | 20 patients |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 29/04/2003 |
| Date of final enrolment | 30/09/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Royal Free Hampstead NHS Trust
London
NW3 2QG
United Kingdom
NW3 2QG
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Hospital/treatment centre
The Royal Free Hampstead NHS Trust (UK)
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 |
Editorial Notes
07/12/2015: no publications found on PubMed.
