prematurity
Conditions
Interventions
Infants will be randomised between the Dolphin concept or placebo for a period
of 12 months. The supplement can be added to a normal diet. The Dolphin concept
consists of a combination of docosahexa
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
No minimum to 1 Years
Inclusion criteria
Inclusion criteria: 1. Written informed consent of custodial caregivers 2. Preterm born infant with a gestational age at birth
Exclusion criteria
Exclusion criteria: 1. Any relevant proven or suspected chromosomal anomaly, metabolic disorder or genetic syndrome 2. Presence of a congenital central nervous system infection or malformation 3.Presence of any congenital gastrointestinal malformation 4. No realistic prospect of survival at the discretion of the attending physician 5. Expected or foreseen inability of the subject*s custodial caregivers to adhere to protocol instructions 6. (Previous) participation in other nutritional intervention studies involving investigational or marketed nutritional products concomitantly or within three weeks prior to start study product intake, that could impact on the main outcome parameters and/or subject safety (at the discretion of the coordinating investigator) 7. Infants who have or are suspected of having a cow*s milk allergy and/or have already started with extensively hydrolyzed milk 8. Infants who have or are suspected of having egg allergy (or products thereof), fish oil allergy (or products thereof) and/or lactose intolerance as these are present in the study product Given the (potential) long time between enrolment and start of the nutritional intervention the custodial caregivers will be contacted at 2-3 weeks prior to term-equivalent age. At this time, infants can drop out of the study due to the following exclusion criteria: 9. Infants who are not fully enterally fed and/or unlikely to start the nutritional intervention at home or at the peripheral hospital at 40-43 weeks post-menstrual age 10. Infants who are expected to be unable to undergo MRI under sedation at three months of corrected age.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is white matter microstructure integrity, specifically: diffusion tensor imaging derived Fractional Anisotropy of white matter tracts at three months corrected age, analysed using Tract-Based Spatial Statistics (TBSS). | — |
Secondary
| Measure | Time frame |
|---|---|
| PARCA-R questionnaire at 24 months Communicative Development Inventories at 12 & 24 months Ages and Stages Questionnaire at 12 & 24 months Bayley Scales of Infant and Toddler Development at 24 months Changes in brain anatomy (volumes, cortical thickness, etc) on MRI Anthropometry at 0, 1, 3, 12 & 24 months Safety throughout study | — |
Countries
Netherlands
Contacts
Public ContactN.E. van der Aa
Universitair Medisch Centrum Utrecht
Outcome results
None listed