Exploratory randomised double-blind controlled trial of breast milk fortifier with and without long chain polyunsaturated fatty acid (LCPUFA) supplementation on body composition in preterm infants
| ISRCTN | ISRCTN59878178 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59878178 |
| Protocol serial number | N/A |
| Sponsor | Milupa GmbH, Numico Research (Germany) |
| Funder | Numico Research Germany |
- Submission date
- 06/09/2005
- Registration date
- 13/09/2005
- Last edited
- 30/08/2007
- 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
Prof Neena Modi
Scientific
Scientific
Imperial College London
Chelsea & Westminster Hospital
369 Fulham Road
London
SW10 9NH
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Breast milk fortifier containing LCPUFA has a measurable effect upon body composition at term when compared with non-LCPUFA supplemented fortifier |
| Ethics approval(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | Preterm infants |
| Intervention | Infants will receive maternal +/- donor breast milk; should breast milk fortifier be indicated in accordance with normal clinical practice, infants will be randomised to receive standard fortifier or LCPUFA supplemented fortifier. |
| Intervention type | Other |
| Primary outcome measure(s) |
Body composition at age term-equivalent |
| Key secondary outcome measure(s) |
Growth, metabolic profile, intrahepatocellular lipid content, brain growth and development, neurological examination |
| Completion date | 30/06/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Not Specified |
| Target sample size at registration | 42 |
| Key inclusion criteria | Infants born at or below 32 weeks gestational age |
| Key exclusion criteria | 1. Major congenital abnormality 2. Mother does not wish to provide breast milk or to use donor milk 3. Baby requires gastrointestinal surgery |
| Date of first enrolment | 01/08/2005 |
| Date of final enrolment | 30/06/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
- Germany
Study participating centre
Imperial College London
London
SW10 9NH
United Kingdom
SW10 9NH
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 |
