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 |
| Protocol serial number | N0256124183 |
| Sponsor | Department of Health |
| Funder | The Royal Free Hampstead NHS Trust (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Service outcome development |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/09/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Royal Free Hampstead NHS Trust
London
NW3 2QG
United Kingdom
NW3 2QG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
07/12/2015: no publications found on PubMed.
