Skin-to-skin After Delivery in Preterm Infants Born at 28-32 Weeks of Gestation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Skin-to-skin After Delivery in Preterm Infants Born at 28-32 Weeks of Gestation. A Randomized Controlled Trial

Conditions
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Premature Birth

Intervention / Treatment
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* Behavioral: skin-to-skin
* Behavioral: standard care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preterm infants at 28-32 weeks of gestation (born 12-8 weeks before term) Exclusion Criteria: Infants who need immediate medical interventions

Ages Eligible for Study
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Minimum Age: 28 Weeks
Maximum Age: 32 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: skin-to-skin<br>immediately after birth the baby is laid on mother's chest for as long as justifiable medically to max 2 hours. | Behavioral: skin-to-skin<br> <br> |
| Active Comparator: standard care<br>after birth the baby is transferred to the neonatal intensive care unit | Behavioral: standard care<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cognitive scorer at two years corrected age | measured by Bayley Scales of Infant Development Third Edition (BSID III) | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in heart rate |  | 24 hours | 
| 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 | assessed with the General Movement Assessment (GMA) | 3 months | 
| Nutrition | based on a Norwegian questionnaire, based on a Norwegian national survey from The Norwegian Directorate of Health. | 1 year | 
| Social/emotional competence at three months corrected age | measured with the Ages and Stages Questionnaire: Social Emotional (ASQ:SE) | 3 months | 
| Social/emotional competence at two years corrected age | measured with the Ages and Stages Questionnaire: Social Emotional (ASQ:SE) | 1 year | 
| Social/emotional competence at two years corrected age | measured with the Ages and Stages Questionnaire: Social Emotional (ASQ:SE) | 2 years | 
| Developmental skills at two years corrected age | measured with the Ages and Stages Questionnaire: (ASQ) | 1 year | 
| Developmental skills at two years corrected age | measured with the Ages and Stages Questionnaire: (ASQ) | 2 years | 
| Maternal anxiety | measured with State-Trait Anxiety Inventory (STAI) | at discharge from hospital | 
| Maternal anxiety | measured with State-Trait Anxiety Inventory (STAI) | 3 months | 
| Maternal anxiety | measured with State-Trait Anxiety Inventory (STAI) | 2 years | 
| Child Behaviour | Measured with Child Behaviour Checklist | 5 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kangaroo-Mother Care Method, Stress, Physiological