The aim of the study is to investigate physiological response, social/emotional response and general movements in preterm infants when they are given skin-to-skin contact with the mother (intervention) or standard care (incubator) right after delivery. Preterm infants will be randomized to either intervention or standard care group. Data on body temperature, blood glucose, hart rate, respiration rate and oxygen saturation will be obtained. In addition the infant will be video-recorded during the first 24 hours and at three months of age for analysis of the general movements.
Power calculations are based on a difference in Bayley Scale of Infant Development III, cognitive scale at two years corrected age of about 7,5 mean score =0.5 SD (α=0,05, β=0.80). Based on this analysis, 64 preterm infants are needed in each group to yield statistic significance. Allowing for withdrawals, the sample size is set to 68 in each group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
108
IWK Health Centre
Halifax, Canada
Nyfødt intensiv, Drammen sykehus
Drammen, Norway
Nyfødt intensiv, Sørlandet Sykehus
Kristiansand, Norway
NICU St Olavs Hospital
Trondheim, Norway
cognitive scorer at two years corrected age
measured by Bayley Scales of Infant Development Third Edition (BSID III)
Time frame: 2 year
change in heart rate
Time frame: 24 hours
change in body temperature
Time frame: 24 hours
change in respiration frequency
Time frame: 24 hours
change in blood glucose
Time frame: 24 hours
general movements (GM) at 3 months corrected age
assessed with the General Movement Assessment (GMA)
Time frame: 3 months
Nutrition
based on a Norwegian questionnaire, based on a Norwegian national survey from The Norwegian Directorate of Health.
Time frame: 1 year
Social/emotional competence at three months corrected age
measured with the Ages and Stages Questionnaire: Social Emotional (ASQ:SE)
Time frame: 3 months
Social/emotional competence at two years corrected age
measured with the Ages and Stages Questionnaire: Social Emotional (ASQ:SE)
Time frame: 1 year
Social/emotional competence at two years corrected age
measured with the Ages and Stages Questionnaire: Social Emotional (ASQ:SE)
Time frame: 2 years
Developmental skills at two years corrected age
measured with the Ages and Stages Questionnaire: (ASQ)
Time frame: 1 year
Developmental skills at two years corrected age
measured with the Ages and Stages Questionnaire: (ASQ)
Time frame: 2 years
Maternal anxiety
measured with State-Trait Anxiety Inventory (STAI)
Time frame: at discharge from hospital
Maternal anxiety
measured with State-Trait Anxiety Inventory (STAI)
Time frame: 3 months
Maternal anxiety
measured with State-Trait Anxiety Inventory (STAI)
Time frame: 2 years
Child Behaviour
Measured with Child Behaviour Checklist
Time frame: 5 year
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