The Preterm Prebiotic Study

ISRCTN	ISRCTN77444690
DOI	https://doi.org/10.1186/ISRCTN77444690
Protocol serial number	NRG / II DbCoRPMc / PT EL 01
Sponsor	Milupa GmbH, Numico Research (Germany)
Funder	Numico Research (Germany)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Neena Modi
Scientific

Imperial College London
Chelsea & Westminster Hospital
369 Fulham Road
London
SW10 9NH
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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
Health condition(s) or problem(s) studied	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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Galacto-oligosaccharides (GOS)/fructo-oligosacharides (FOS)
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	30/06/2007

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	160
Key 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
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	01/10/2005
Date of final enrolment	30/06/2007

Imperial College London

London
SW10 9NH
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2010		Yes	No