Heathy term infants with intercurrent diseases: diarrhoea and respiratory infections Neonatal Diseases Other conditions originating in the perinatal period
Conditions
Interventions
Treatment consists of three types of infant formula:
1. Standard infant formula (frisolac 1) without addition of prebiotics or probiotics
2. Standard infant formula with addition of galacto-oligos
0.8 g/100 ml (Vivinal Domo, The Netherlands. GOS 10 contains: 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. Stan
Sponsors
Royal Friesland Foods B.V. (The Netherlands)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy term infants with a post-menstrual age of 37 - 42 weeks, either sex 2. Birth weight between P10 and P90 3. Informed consent of both parents
Exclusion criteria
Exclusion criteria: 1. Neonatal sepsis 2. Severe congenital malformations 3. Birth asphyxia (apgar less than six at 5 minutes, and/or umbilical cord pH less than 7.00 and/or necessity of reanimation) 4. Admission to a paediatric ward 5. No Dutch or English speaking parents 6. Antibiotics to the mother during labour 7. Antibiotics to the infant in the first week of life 8. History of allergy with parents or siblings
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Frequency, incidence and duration of diarrhoea and respiratory infections, measured during the first 6 months of life and evaluated by the questionnaires 2. Composition of gut flora, evaluated at week 6, 3 months and 6 months of life (during the period infants receive the study feeds) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Growth (head circumference, length and weight), measured in the out-patient clinic at 3 and 6 months 2. Feeding tolerance (pattern of defaecation, consistence of faeces, crying, vomiting, stomach ache), assessed with standardised questions | — |
Countries
Netherlands
Outcome results
None listed