Condition category
Nutritional, Metabolic, Endocrine
Date applied
09/05/2008
Date assigned
12/09/2008
Last edited
12/09/2008
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 Diny van Zoeren-Grobben

ORCID ID

Contact details

Isala Clinics
Neonatal Unit
Dr. Van Heesweg 2
Zwolle
8025 AB
Netherlands
+31 (0)38 424 7073
d.van.zoeren@isala.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

06-1179

Study information

Scientific title

Acronym

VIPP prematuur

Study hypothesis

Supplementation of preterm formula with prebiotics or lactoferrin may improve the gut flora of preterm infants by promoting growth of apathogenic bacteria. These supplements may produce a gut flora resembling the gut flora of human milk-fed preterm infants and thereby improve their resistance against infections.

Furthermore lactoferrin reduces the availability and absorption of free iron and may thus reduce oxidative stress both locally in the gut and systemically.

Ethics approval

Ethcis approval received from the Medical Ethical Committee of the Isala Clinics according to article 16 WMO and to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (ICH/GCP) criteria on the 8th February 2007 (ref: 06.1179).

Study design

Double-blind placebo-controlled randomised prospective cohort study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Gut flora

Intervention

Treatment consists of three types of preterm formula:
1. Standard preterm formula (frisolac prematuur) without addition of prebiotics
2. Standard preterm formula with addition of galacto-oligosaccharides (GOS); 0.8 g/100 ml (Vivinal Domo, The Netherlands. GOS 10 containing: galacto-oligosaccarides 28.5%, lactose 36%, glucose 9.5%, galactose 0.5%, proteins 17.5%, minerals 3.5%, fat 1.5%, moisture 3.0%)
3. Standard preterm formula with addition of dairy lactoferrin 1 mg/100 ml (Vivinal Domo, The Netherlands, containing lactoferrin 90 %, protein 97%, moisture 1.5%, minerals 1.5 %)

The therapy wil be started in the first week of life and therapy will be continued until 6 weeks after the start of full enteral feeds. Blood will be drawn at day 1, day 7, day of full enteral feeds and week 6 after establishment of full enteral feeds. Follow up wil be done at the age of 1 year corrected age.

Intervention type

Drug

Phase

Not Specified

Drug names

Prebiotic, lactoferrin

Primary outcome measures

1. Composition of gut flora, evaluated at 6 weeks of full enteral feeds (at the end of the study feeding)
2. Incidence of infections, measured at 6 weeks of full enteral feeds
3. Oxidative stress and iron status, measured at 6 weeks of full enteral feeds

Secondary outcome measures

1. Growth (head circumference, length, weight), measured at 6 weeks of full enteral feeds
2. Feeding tolerance (composition of faeces, crying pattern, discomfort, vomiting), measured at 6 weeks of full enteral feeds
3. Psychomotor development, taken at 1 year of age

Overall trial start date

01/04/2007

Overall trial end date

01/04/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Preterm infants: gestational age 26+0 to 35+6 weeks, either sex
2. Admitted to the Neonatal Intensive Care Unit (NICU) or High Care Unit of the hospital

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

Preterm formula group: n = 60 (20 in each group). Human milk group: n = 20.

Participant exclusion criteria

1. Birth weight less than 600 g
2. Life-threatening congenital malformations
3. No Dutch or English speaking parents
4. History of allergy in parents or siblings

Recruitment start date

01/04/2007

Recruitment end date

01/04/2009

Locations

Countries of recruitment

Netherlands

Trial participating centre

Isala Clinics
Zwolle
8025 AB
Netherlands

Sponsor information

Organisation

Royal Friesland Foods B.V. (The Netherlands)

Sponsor details

c/o Dr R te Biesebeke
Enhanced Nutrition Specialist Unit
P. Stuyvesantweg 1
Leeuwarden
8937 AC
Netherlands

Sponsor type

Industry

Website

http://www.frieslandfoods.com/

Funders

Funder type

Industry

Funder name

Royal Friesland Foods B.V. (The Netherlands)

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