Condition category
Neonatal Diseases
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
01/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Khalid N Haque

ORCID ID

Contact details

Epsom and St Helier NHS Trust
Department of Neonatology
Queen Mary's Hospital for Children
Wrythe Lane
Carshalton
SM5 1AA
United Kingdom
+44 (0)20 8296 2930

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0112173765

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Prospective double-blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Galacto-oligosaccharides (GOS) and fructo-oligosaccharides (FOS) are prebiotic bifidogenic oligosaccharides.

Primary outcome measures

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 trial start date

02/12/2005

Overall trial end date

31/08/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

4

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

02/12/2005

Recruitment end date

31/08/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Epsom and St Helier NHS Trust
Carshalton
SM5 1AA
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Epsom and St Helier University Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes