The main objective is to study the effect of a nutritional intervention on white matter integrity at the corrected age of three months in infants born at a gestational age <30+0 weeks. Secondary objectives of the study are to determine the…
ID
Source
Brief title
Condition
- Encephalopathies
Health condition
Encephalopathy of prematurity
Research involving
Sponsors and support
Faculty of Social and Behavioral Sciences, Utrecht University
Danone Nutricia Research
Dep. of Neonatology, UMC Utrecht
Intervention
- Food (substances)
Outcome measures
Primary outcome
The primary outcome parameter in this study is white matter microstructural integrity, specifically: DTI-derived FA of white matter tracts at a corrected age of 3 months (Time-point 5), analyzed using TBSS.
Secondary outcome
The secondary outcome parameter will be neurodevelopmental follow-up outcomes, specifically: cognitive and motor scores on the Bayley Scales of Infant and Toddler Development-III (BSID-III) at the corrected age of 2 years (Time-point 9). Additional secondary outcomes include cognitive and language development as measured by standardized questionnaires including the N-Communicative Development Inventories, Ages & Stages Questionnaire (Time-point 7 & 9), and Parent Report of Children’s Abilities-Revised (Time-point 9). Furthermore, other measures on brain anatomy, including brain tissue volumes, cortical morphology, and other DTI parameters (radial, axial, and mean diffusivity) will be derived from T1-, T2- and diffusion weighted MRI scans (Time-point 5).
Background summary
Early neonatal events affecting brain development can have long-lasting consequences for motor and cognitive outcome. At present, medical treatment options for brain-injured infants are limited. Optimizing nutrition during the first years after birth of rapid brain development may provide a means to improve neurodevelopment.
Study objective
The main objective is to study the effect of a nutritional intervention on white matter integrity at the corrected age of three months in infants born at a gestational age <30+0 weeks. Secondary objectives of the study are to determine the effect of the nutritional intervention on neurodevelopmental outcomes at 12 to 24 months corrected age, safety and other MRI parameters.
Study design
A total of 130 infants will be randomized (1:1) to receive test or control product at home until 12 months corrected age in an exploratory randomized, placebo-controlled, double blind, parallel group, multi-center, single country trial. The follow-up period without study product starts after finishing the nutritional intervention around 12 months corrected age and continues until 24 months corrected age.
Intervention
The investigational supplement is a nutrient blend containing a.o. long-chain polyunsaturated fatty acids (LCPUFAs), choline, Uridine-5’-Monophosphate (UMP), and cytidine monophosphate (CMP).
Age
Inclusion criteria
1. Written informed consent of custodial caregivers
2. Preterm born infants born at a gestational age <30+0 weeks
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 (note that infants with acquired brain injury such as hemorrhages, white matter injury or stroke are eligible for inclusion)
3. Presence of any congenital gastrointestinal malformation (infants with a stoma following surgery are not necessarily excluded, at the discretion of the attending physician)
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
9. Withdrawal of informed consent by custodial caregivers
10. Infants who are not fully enterally fed and/or unlikely to start the nutritional intervention at home at 40-43 weeks post-menstrual age
11. Infants who are expected to be unable to undergo MRI under sedation at three months of corrected age.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9814 |
| Other | METC UMCU : METC 21-504/M |
| CCMO | NL72700.041.21 |
| OMON | NL-OMON56181 |