Gut flora Nutritional, Metabolic, Endocrine Gut flora
Conditions
Interventions
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-oligosacc
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. St
Sponsors
Royal Friesland Foods B.V. (The Netherlands)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Netherlands
Outcome results
None listed