Effect of Skin-to-skin Contact on Interaction and Parents' Sleep

Study Overview
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Brief Summary
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This study evaluates the effect of a late intervention of continuous skin-to-skin contact (SSC) in the neonatal intensive care unit (NICU). Half of the participants will receive the intervention and the other half will receive standard care.

Detailed Description
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The intervention is based on a method developed to facilitate closeness and human touch between parents and preterm infants in neonatal intensive care. Continuous skin-to-skin contact (SSC) means, in this study, that the late preterm infant is cared for skin-to-skin on the parents' chest, instead of in a heating-bed, 24 hours a day. The parents will take turns to care for the infant in SSC.

Official Title
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Effect of Skin-to-skin Contact on Interaction and Parents' Sleep

Conditions
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Sleep Quality, Communication, Stress Reaction

Intervention / Treatment
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* Behavioral: Continuous skin-to-skin contact
* Other: Standard Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parents staying at the NICU with a single preterm infant born <33 weeks of gestation The family should have been transferred to family-room from intensive care Swedish speaking parents Exclusion Criteria: Infants with major congenital malformation, Infants with intraventricular hemorrhage grade III-IV Infants with chromosome defect that could affect the infant´s ability to interact. Parents with sleeping disorder Parents with psychiatric problem or drug use.
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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous skin-to-skin contact<br>Infants assigned to SSC will rest skin-to-skin on parents' chest 24 hours a day for four days alternating between the parents. | Behavioral: Continuous skin-to-skin contact<br>* Infants will rest in skin-to-skin contact on parents' chest 24 hours a day alternating between the parents. The parents will note who provides the SSC and if and for how long they are off SSC for any reason.<br>|
| Active Comparator: Standard Care<br>Infants and parents will receive standard care provided in the NICU | Other: Standard Care<br>* Infants will receive regular care in the NICU. Parents may practice SSC if they like. Parents will note if, with whom, and for how long they provide SSC.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep quality | sleep diary every day for five days | Day 1 to 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mood | Mood Adjective Checklist (MACL) | day 2 to 5 | 
| Bonding | Mother to Infant Bonding Scale (MIBS) | Baseline and 1-3 days before planned discharge from the NICU. | 
| Depression | The Edinburgh Postnatal Depression Scale, EPDS | Baseline and 1-3 days before planned discharge from the NICU. | 
| Anxiety | State Trait Anxiety Inventory, STAI | Baseline and 1-3 days before planned discharge from the NICU. | 
| Activity | Actigraph every day for five days | Day 1-5 |