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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous skin-to-skin contact | Experimental | Infants assigned to SSC will rest skin-to-skin on parents' chest 24 hours a day for four days alternating between the parents. |
|
| Standard Care | Active Comparator | Infants and parents will receive standard care provided in the NICU |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous skin-to-skin contact | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep quality | sleep diary every day for five days | Day 1 to 5 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Evalotte Mörelius, PhD | Linkoeping University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Linköping | Sweden | ||||
| University hospital Örebro |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33277288 | Derived | Morelius E, Olsson E, Sahlen Helmer C, Thernstrom Blomqvist Y, Angelhoff C. External barriers for including parents of preterm infants in a randomised clinical trial in the neonatal intensive care unit in Sweden: a descriptive study. BMJ Open. 2020 Dec 4;10(12):e040991. doi: 10.1136/bmjopen-2020-040991. | |
| 30068615 | Derived |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D003142 | Communication |
| D015775 | Fractures, Stress |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard Care | Other | 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. |
|
| 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 |
| Örebro |
| Sweden |
| Uppsala University Hospital | Uppsala | Sweden |
| Angelhoff C, Blomqvist YT, Sahlen Helmer C, Olsson E, Shorey S, Frostell A, Morelius E. Effect of skin-to-skin contact on parents' sleep quality, mood, parent-infant interaction and cortisol concentrations in neonatal care units: study protocol of a randomised controlled trial. BMJ Open. 2018 Aug 1;8(7):e021606. doi: 10.1136/bmjopen-2018-021606. |
| D001523 |
| Mental Disorders |
| D001519 | Behavior |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |