The main objective of the study is to provide insight in the developmental problems of very premature and/or VLBW children compared to their term born peers, and to investigate the possible beneficial longitudinal effects of the GEEF intervention on…
ID
Source
Brief title
Condition
- Structural brain disorders
- Neonatal and perinatal conditions
- Psychiatric disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Differences as measured by neurocognitive assessment, behavioural and emotional
questionnaires, and school performance. Furthermore, differences in brain
structure as determined by sMRI (volumetric parameters of white and grey
matter) fMRI (BOLD-signal changes) and DTI (FA-value indicating white matter
integrity).
Secondary outcome
Not applicable
Background summary
Follow-up study of very premature (<32 weeks of gestation) and/or very low
birth weight (VLBW, < 1500 grams) infants who participated in the Glutamine
Enriched Enteral Feeding-study (GEEF, van den Berg et al., 2004), to determine
the effects of glutamine supplementation on later developmental outcomes.
Study objective
The main objective of the study is to provide insight in the developmental
problems of very premature and/or VLBW children compared to their term born
peers, and to investigate the possible beneficial longitudinal effects of the
GEEF intervention on these problems. This will be done by gathering information
concerning the neurocognitive performance, behavioural/emotional development,
performance at school and brain development (by conducting brain imaging) of
very premature and/or VLBW children from the GEEF-intervention study (both
glutamine and placebo condition) and term born controls.
Study design
Observational study
Study burden and risks
Each participant will be asked to visit the VU University Medical Center twice.
During the first visit of approximately 3 hours including breaks, the
neurocognitive assessment (childen) and the questionnaires (parents) will be
administrated. During the second visit of approximately 1 hour, brain scanning
will be conducted.
For participants, the burden of the neurocognitive assessment is minimal.
Experiences from earlier studies with children in this age range have taught us
that the proposed length of assessment is feasible. During brain scanning,
discomfort can be expected from loud noise and claustrophobia. This discomfort
will be minimized by providing ear plugs and close company of a familiar person
as much as possible during the procedure. Risks associated with participation
are negligible.
De Boelelaan 1117
1081 HV Amsterdam
NL
De Boelelaan 1117
1081 HV Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Participation with the original GEEF-study (which had the inclusioncriteria: <32 weeks of gestation and/or lower than 1500 grams birth weight).
Exclusion criteria
Deafness or Blindness, which will make the assessment of neuropsychological tasks impossible
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL28378.029.09 |