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
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