Premature Birth
Conditions
Keywords
Kangaroo-Mother Care Method, Stress, Physiological
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALskin-to-skin
BEHAVIORALstandard care
Sponsors
St. Olavs Hospital
Drammen sykehus
Sorlandet Hospital HF
IWK Health Centre
Norwegian University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
28 Weeks to 32 Weeks
Healthy volunteers
No
Inclusion criteria
* Preterm infants at 28-32 weeks of gestation (born 12-8 weeks before term)
Exclusion criteria
* Infants who need immediate medical interventions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cognitive scorer at two years corrected age | 2 year | measured by Bayley Scales of Infant Development Third Edition (BSID III) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in body temperature | 24 hours | — |
| change in respiration frequency | 24 hours | — |
| change in blood glucose | 24 hours | — |
| general movements (GM) at 3 months corrected age | 3 months | assessed with the General Movement Assessment (GMA) |
| Nutrition | 1 year | based on a Norwegian questionnaire, based on a Norwegian national survey from The Norwegian Directorate of Health. |
| change in heart rate | 24 hours | — |
| Social/emotional competence at two years corrected age | 1 year | measured with the Ages and Stages Questionnaire: Social Emotional (ASQ:SE) |
| Developmental skills at two years corrected age | 1 year | measured with the Ages and Stages Questionnaire: (ASQ) |
| Maternal anxiety | at discharge from hospital | measured with State-Trait Anxiety Inventory (STAI) |
| Child Behaviour | 5 year | Measured with Child Behaviour Checklist |
| Social/emotional competence at three months corrected age | 3 months | measured with the Ages and Stages Questionnaire: Social Emotional (ASQ:SE) |
Countries
Canada, Norway
Outcome results
None listed