None listed
Conditions
Interventions
Randomization to post discharge or term formula between 0 and 6 months corrected age. Breast milk group as a control group.
All the formula and the breast milk with fortifier are prescribed in a volu
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: Gestational age <= 32 weeks with a birth weight <= 2000 grams or a birth weight <= 1500 grams and a gestational age <= 34 weeks. At least one parent or caretaker who speaks Dutch or English.
Exclusion criteria
Exclusion criteria: Conditions that influence the growth like: 1. Severe congenital anomalies; 2. Bronchopulmonary dysplasia defined as an O2 requirement above 25% at 36 weeks gestation, any O2 requirement at 38 weeks gestation or any respiratory support at 40 weeks gestatio'; 3. Severe intracerebral haemorrhage or ischaemia diagnosed before inclusion; 4. Gastrointestinal surgery and gastro-intestinal diseases known to influence growth.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Growth and body composition (bone density, fat percentage). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Anemia; 2. bone markers; 3. protein status; 4. metabolism (o.a. glucose, cholesterol, IGF-I); 5. free fatty acids in red blood cells; 6. neurodevelopment. | — |
Contacts
Public ContactE.M. Amesz
VU University Medical Center, Department of Paediatrics/Neonatology, P.O. Box 7057, dep 9D11
Outcome results
None listed