Weighted Blankets With Infants With NAS
Primary Purpose
Neonatal Abstinence Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weighted Blanket
Non-Weighted Blanket
Sponsored by
About this trial
This is an interventional other trial for Neonatal Abstinence Syndrome
Eligibility Criteria
Inclusion Criteria:
- Admitted to the NICU
- Gestational age > 37 weeks
- Positive maternal drug screen at delivery
Exclusion Criteria:
- Clinical staff does not give permission to enroll the patient
- Had intrauterine growth restriction (IUGR)
- Has any medical diagnosis in addition to NAS diagnosis
- Has a weight below the 10th percentile
Sites / Locations
- Good Samaritan Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Weighted Blanket First
Non-weighted Blanket First
Arm Description
This group will receive the Weighted Blanket first and then the Non-weighted blanket
This group will receive the Non-weighted Blanket first and then the Weighted blanket
Outcomes
Primary Outcome Measures
Change in Finnegan Score
Finnegan scale measures signs of neonatal drug withdrawal syndrome. It provides a summative score obtained from the assessment of 21 items related to neonatal withdrawal. The total score ranges from 0 to 43 with a higher score indicating more severe symptoms. Values above 8 have been described as being indicative of neonatal abstinence syndrome.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03113656
Brief Title
Weighted Blankets With Infants With NAS
Official Title
The Use of Weighted Blankets in the Care of Infants With Neonatal Abstinence Syndrome (NAS)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
July 14, 2017 (Actual)
Primary Completion Date
December 1, 2017 (Actual)
Study Completion Date
January 18, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TriHealth Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Infants with neonatal abstinence syndrome (NAS) who are cared for in a Neonatal Intensive Care Unit (NICU) often display symptoms including hyperactivity, irritability, jitteriness, poor feeding, and poor sleep patterns. The recommended first line of treatment to relieve these symptoms involves nonpharmacological interventions. The purpose of the current pilot study is to provide preliminary data to assist in the design of a larger scale study to examine one nonpharmacological intervention, weighted blankets. The pilot study will assess the feasibility of a cross-over randomized controlled design to study the impact of a weighted blanket on infants' symptoms of NAS.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Abstinence Syndrome
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Weighted Blanket First
Arm Type
Experimental
Arm Description
This group will receive the Weighted Blanket first and then the Non-weighted blanket
Arm Title
Non-weighted Blanket First
Arm Type
Experimental
Arm Description
This group will receive the Non-weighted Blanket first and then the Weighted blanket
Intervention Type
Other
Intervention Name(s)
Weighted Blanket
Intervention Description
Weighted blanket placed on infant for 30 minutes
Intervention Type
Other
Intervention Name(s)
Non-Weighted Blanket
Intervention Description
Non-Weighted blanket placed on infant for 30 minutes
Primary Outcome Measure Information:
Title
Change in Finnegan Score
Description
Finnegan scale measures signs of neonatal drug withdrawal syndrome. It provides a summative score obtained from the assessment of 21 items related to neonatal withdrawal. The total score ranges from 0 to 43 with a higher score indicating more severe symptoms. Values above 8 have been described as being indicative of neonatal abstinence syndrome.
Time Frame
baseline and 30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
37 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Admitted to the NICU
Gestational age > 37 weeks
Positive maternal drug screen at delivery
Exclusion Criteria:
Clinical staff does not give permission to enroll the patient
Had intrauterine growth restriction (IUGR)
Has any medical diagnosis in addition to NAS diagnosis
Has a weight below the 10th percentile
Facility Information:
Facility Name
Good Samaritan Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
12. IPD Sharing Statement
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Weighted Blankets With Infants With NAS
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