A prospective double-blind randomised controlled trial of the effect of a prebiotic mixture of bifidogenic oligosaccharides on enteral tolerance in preterm infants
| ISRCTN | ISRCTN72367147 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72367147 |
| Secondary identifying numbers | N0112173765 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 01/10/2014
- 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 Khalid N Haque
Scientific
Scientific
Epsom and St Helier NHS Trust
Department of Neonatology
Queen Mary's Hospital for Children
Wrythe Lane
Carshalton
SM5 1AA
United Kingdom
| Phone | +44 (0)20 8296 2930 |
|---|
Study information
| Study design | Prospective double-blind randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | The aim of the study is to determine if supplementation of preterm infant milk formula with 0.8g GOS/FOS mixture/dl (galacto-oligosaccharides (GOS) and fructo-oligosaccharides (FOS) are prebiotic bifidogenic oligosaccharides) will lead to an improvement in enteral tolerance and a more rapid establishment of milk feeds. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Neonatal Diseases |
| Intervention | Suitable babies less that 32+6 weeks gestation who are also of appropriate birth weight for gestational age will be identified by neonatal unit staff. Parent will be approached and explanation of study given by the first 24 hours prior to starting of feeds. Formula milk will only be used if there is a shortfall in the volume available of their own mother's milk, or as sole diet if maternal milk is unavailable. Randomisation will be performed to either a standard preterm formula or to one with GOS/FOS these will be labelled either A or labelled formula. Enteral feeding will be commenced within 24 hours of birth. Measurements will be taken on four/five occasions: 1. Day 1: commencement of enteral feed 2. Day 2: the first day of enteral feeding at a volume of 150 ml/kg 3. Day 3: day 28 of post-natal life 4. Day 4: the day when 37 weeks of gestational age is reached 5. Day 5: the day when 40 weeks of gestation age would have been reached, or the day of discharge, whichever occurs earlier Information collected on the Case Report Form (CRF) will be logged with the trial administrator who will check for completeness. The principal investigator will coordinate CRFs and trial database at Imperial. Stool samples will be collected from the nappy on day 1 and 3. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Galacto-oligosaccharides (GOS) and fructo-oligosaccharides (FOS) are prebiotic bifidogenic oligosaccharides. |
| Primary outcome measure | 1. Number of days from birth to establish 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 (change in Z score between birth and 40 weeks postmenstrual age) 2. Faecal flora (colony forming units/g stool of Bifidus sp., Lactobacilli sp., and pathogenic micro-organisms) 3. Faecal calprotectin 4. Stool characteristics 5. Gastrointestinal tolerance 6. Fluid balance (the number of days between trial entry and 28 days where serum sodium exceeds 148 mmol/l or serum creatinine exceeds 150 micromol/l) 7. Proven necrotising enterocolitis according to predefined diagnostic criteria 8. Proven bloodstream infection according to predefined diagnostic criteria |
| Overall study start date | 02/12/2005 |
| Completion date | 31/08/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 4 |
| Key inclusion criteria | 1. Written informed parental consent 2. Preterm infants, appropriately grown for gestational age (Child Growth Foundation UK reference), with a gestational age of 32 weeks, whose mother agree to the use of formula if they are unable to or do not wish to breastfeed or are not able to provide sufficient breast milk |
| Key exclusion criteria | 1. More than 72 hours exclusive parenteral nutrition 2. Immediately life-threatening congenital abnormality 3. Any condition requiring major surgery |
| Date of first enrolment | 02/12/2005 |
| Date of final enrolment | 31/08/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Epsom and St Helier NHS Trust
Carshalton
SM5 1AA
United Kingdom
SM5 1AA
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Epsom and St Helier University Hospitals NHS Trust (UK)
No information available
NHS R&D Support Funding (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 |
