The Preterm Prebiotic Study
| ISRCTN | ISRCTN77444690 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77444690 |
| Secondary identifying numbers | NRG / II DbCoRPMc / PT EL 01 |
- Submission date
- 20/08/2005
- Registration date
- 12/09/2005
- Last edited
- 01/02/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Prof Neena Modi
Scientific
Scientific
Imperial College London
Chelsea & Westminster Hospital
369 Fulham Road
London
SW10 9NH
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 | Treatment |
| Scientific title | |
| Study hypothesis | Supplementation of a preterm formula with 0.8 g galacto-oligosaccharides (GOS)/fructo-oligosacharides (FOS) mixture per dl (ratio: 9:1) will result in an improvement in enteral tolerance. |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Neonatal nutritional supplementation |
| Intervention | Infants randomised to one of two groups receiving either Nutriprem A or B, one without and one with 0.8 g GOS/FOS oligosaccharides /dl, to make up any shortfall in their own mothers milk or as sole diet if maternal milk is unavailable. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Galacto-oligosaccharides (GOS)/fructo-oligosacharides (FOS) |
| Primary outcome measure | 1. Number of days from birth to reach a total (sole formula or formula with breast milk) daily enteral intake of 150 ml/kg 2. Number of days between birth and 28 days that a total (sole formula or formula with breast milk) daily enteral intake of at least 150 ml/kg is tolerated |
| Secondary outcome measures | 1. Gain in weight, length and head circumference 2. Faecal flora 3. Faecal calprotectin 4. Faecal characteristics 5. Gastrointestinal tolerance 6. Fluid balance 7. Necrotising enterocolitis 8. Bloodstream infection |
| Overall study start date | 01/10/2005 |
| Overall study end date | 30/06/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 160 |
| Participant inclusion criteria | Preterm infants, appropriately grown for gestational age, with a gestational age ≤32 + 6 weeks (days), whose mothers agree to the use of formula if they are unable to or do not wish to breast feed or are not able to provide sufficient breast milk |
| Participant exclusion criteria | 1. More than 72 hours exclusive parenteral nutrition 2. Immediately life-threatening congenital abnormality 3. Any condition requiring major surgery |
| Recruitment start date | 01/10/2005 |
| Recruitment end date | 30/06/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Imperial College London
London
SW10 9NH
United Kingdom
SW10 9NH
United Kingdom
Sponsor information
Milupa GmbH, Numico Research (Germany)
Industry
Industry
Bahnstrasse 14-30
Friedrichsdorf
61381
Germany
"ROR" |
https://ror.org/00aj77a24 |
|---|
Funders
Funder type
Industry
Numico Research (Germany)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2010 | Yes | No |
