Very Preterm Infant Clinical Trial
Official title:
Effect in the Short and Medium Term of Different Techniques of Tactile Stimulations on Neurological Development in a Population of Very Preterm Infants
Premature birth deprives infants of sensory stimulation. Tactile stimulation such as massage
pressure with kinesthetic movement significantly increases the weight, bone density and
shorten the duration of stay of premature babies who benefits.
Studies using vegetable oils show an increase in the effect on weight gain by cutaneous
absorption. The mechanism is probably vagal (stimulation of baroreceptors and skin
mechanoreceptors) since it is found in children stimulated an increase in the vagal
activity, acceleration of gastric emptying and an increase in the secretion of insulin and
IGF1.
Few studies have evaluated the effects of massage on the medium-term neurological
development in preterm infants and the effect of the essential oils in the effectiveness of
touching the short and medium term massage.
The aim of the investigators study is to evaluate the neurological development in the short
and medium term in premature newborns and biological effects of massage with essential use
of vegetable oil.
Methodology and possible collaborations This is a monocentric, randomized, controlled, in a
neonatal intensive care unit. It concerns 60 children born between 26 and 30 weeks of
amenorrhea. Each child receives massage randomized with or without oil ISIO 4. The treatment
is administered 10 minutes twice a day for 10 consecutive days watching for signs of
intolerance. The quality of the spontaneous motility between 12 and 20 weeks of age
corrected is used as the first neurological assessment criterion.
The questionnaire (ASQ) Bricker and Squires (translated into French by Martha Bonin et al.)
is used to 6, 12, 24 months corrected age and completed by the parents as a second
neurological endpoint.
A lipid chromatography is performed at the beginning and at the end of the massage time and
at the deliverance from NICU for comparing the profile of children's fatty acids.
Expected results Show that there is an improvement in the neurological development in
children who received massage with vegetable oil ISIO 4. Show that there is a skin
absorption of essential fatty acids that can substitute for a known major deficiency in
premature even in infants fed breast milk.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label