Condition category
Neonatal Diseases
Date applied
20/08/2005
Date assigned
12/09/2005
Last edited
01/02/2013
Prospective/Retrospective
Prospectively 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

Prof Neena Modi

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NRG / II DbCoRPMc / PT EL 01

Study information

Scientific title

Acronym

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

Not provided at time of registration

Study design

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 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 mother’s milk or as sole diet if maternal milk is unavailable.

Intervention type

Drug

Phase

Not Applicable

Drug names

Galacto-oligosaccharides (GOS)/fructo-oligosacharides (FOS)

Primary outcome measures

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 trial start date

01/10/2005

Overall trial end date

30/06/2007

Reason abandoned

Eligibility

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 type

Patient

Age group

Neonate

Gender

Both

Target number of participants

160

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

United Kingdom

Trial participating centre

Imperial College London
London
SW10 9NH
United Kingdom

Sponsor information

Organisation

Milupa GmbH, Numico Research (Germany)

Sponsor details

Bahnstrasse 14-30
Friedrichsdorf
61381
Germany

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Numico Research (Germany)

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

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20639792

Publication citations

  1. Results

    Modi N, Uthaya S, Fell J, Kulinskaya E, A randomized, double-blind, controlled trial of the effect of prebiotic oligosaccharides on enteral tolerance in preterm infants (ISRCTN77444690)., Pediatr. Res., 2010, 68, 5, 440-445, doi: 10.1203/PDR.0b013e3181f1cd59.

Additional files

Editorial Notes