Premature birth and low birth weight implies insufficient intrauterine growth and fetal malnutrition. During the first months of life where the infant is breastfed, the low stores aquired during fetal life, may cause specific B vitamin deficiencies. In this study infants with a birth weight below 3000 g will be studied at 6 weeks, 4 and 6 months. At 6 months infants with biochemical signs of impaired cobalamin status (i.e.: tHcy \> 97.5 percentile for cobalamin treated infants, i.e.: tHcy\>6.5 µM/L) will be randomised to cobalamin treatment or placebo. At 7 months the investigators will evaluate the effect of cobalamin or placebo treatment according to infant biochemical status and neurodevelopment. Study hypothesis: Cobalamin treatment given to infants with biochemical cobalamin deficiency will normalize biochemical status and cause improved motor neurodevelopment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
80
Hydroxycobalamin 400 µg (Vitamin B12 depot, Nycomed Pharma ) is given as a single intramuscular injection
needle injection without any substance given
Haukeland University Hospital
Bergen, Norway
Changes in biochemical status and neurodevelopment
Bloodsamples for analysis of B vitamin status are drawn before intervention and after 4 weeks Neurological evaluation (AIMS test) of the infants is done before intervention and after 4 weeks
Time frame: 4 weeks
Maternal evaluation of changes in infant behaviour/development
Maternal evaluation of changes in infant behaviour will be tested by using a maternal questionnaire, Ages and Stages (ASQ), a highly rated child screening and monitoring system, before and after intervention
Time frame: 4 weeks
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