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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
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Preterm newborn sleep deprivation due to medical interventions and environmental characteristics of the Neonatal Intermediate Care Unit (NICU) can increase morbidity and developmental deleterious effects. The aim of this study is to test the effect of earmuffs on sleep pattern of preterm neonates. Prospective, randomized, controlled, crossover study conducted in NICU of two teaching hospitals from São Paulo, Brazil. The effect of earmuffs use was analyzed through polysomnography measurement during four "Quiet times" periods. It was also analyzed sleep related variables during 24 hours of the day. Preterm newborns characteristics and clinical characteristics were also analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| earmuffs | Active Comparator | Preterm newborns with earmuffs during the Quiet time |
|
| control | No Intervention | Preterm newborns without earmuffs during de Quiet time |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| earmuffs | Device | to compare the neonate's sleep with and without earmuffs during Quiet time at the NICU |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sleep period | categorized as the total time of sleep measured by polysomnography | 4 periods of Quiet time (60 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| sleep pattern according to environmental variables | polysomnographic records and clinical environmental variables | 4 periods of Quiet time (60 minutes) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eliana M Pinheiro, phD | Federal University of São Paulo | Study Director |
| Mônica H Sato, MSc | Federal University of São Paulo | Principal Investigator |
| Mavilde LG Pedreira, phD | Federal University of São Paulo | Study Director |
| Ariane M Avelar, phD | Federal University of São Paulo | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal Uiversity of São Paulo | São Paulo | 04024-002 | Brazil |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D004430 | Ear Protective Devices |
| ID | Term |
|---|---|
| D000067393 | Personal Protective Equipment |
| D011482 | Protective Devices |
| D004864 | Equipment and Supplies |
| D011481 | Protective Clothing |
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| D000091642 | Urogenital Diseases |
| D003020 | Clothing |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |