Study Results
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View full resultsBasic Information
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COMPLETED
NA
16 participants
INTERVENTIONAL
2017-07-14
2018-01-18
Brief Summary
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The aims of the study are:
Aim1: To determine the feasibility of recruiting patients for a study evaluating the use of weighted blankets in the care of infants with NAS Aim 2: To determine the feasibility and safety of the study procedures Aim 3: To examine whether there is clinical benefit to using weighted blankets for the treatment of symptoms in infants with NAS.
After informed consent is obtained, infants will be randomized to have either a weighted blanket or a non-weighted blanket placed on them first. A cross-over design will be used so all infants will experience both the non-weighted and weighted blankets. Thirty minutes before each feeding, baseline vital signs and Finnegan score will be obtained. Then, a blanket (weighted or non-weighted) will be placed on the infant for 30 minutes. Infants will be directly monitored and on heart rate/respiratory rate monitors while the blanket is applied. Vital signs and Finnegan scores will be obtained at the end of 30 minutes of blanket placement, infants will be fed, and vital signs and Finnegan scores will be obtained again 30 minutes after the blanket was removed. Descriptive statistics will be used to determine the enrollment rate and feasibility of the protocol. Nonparametric statistics will be used to compare total Finnegan scores for infants with the weighted blanket applied compared to infants with a non-weighted blanket applied. Changes in Finnegan scores will be examined to estimate an effect size to use in a power analysis for a future larger effectiveness study.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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Weighted Blanket First
This group will receive the Weighted Blanket first and then the Non-weighted blanket
Weighted Blanket
Weighted blanket placed on infant for 30 minutes
Non-Weighted Blanket
Non-Weighted blanket placed on infant for 30 minutes
Non-weighted Blanket First
This group will receive the Non-weighted Blanket first and then the Weighted blanket
Weighted Blanket
Weighted blanket placed on infant for 30 minutes
Non-Weighted Blanket
Non-Weighted blanket placed on infant for 30 minutes
Interventions
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Weighted Blanket
Weighted blanket placed on infant for 30 minutes
Non-Weighted Blanket
Non-Weighted blanket placed on infant for 30 minutes
Eligibility Criteria
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Inclusion Criteria
* Gestational age \> 37 weeks
* Positive maternal drug screen at delivery
Exclusion Criteria
* Had intrauterine growth restriction (IUGR)
* Has any medical diagnosis in addition to NAS diagnosis
* Has a weight below the 10th percentile
37 Weeks
ALL
No
Sponsors
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TriHealth Inc.
OTHER
Responsible Party
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Rachel Baker
Nurse Researcher
Locations
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Good Samaritan Hospital
Cincinnati, Ohio, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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17-008
Identifier Type: -
Identifier Source: org_study_id
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