Trial Outcomes & Findings for Weighted Blankets With Infants With NAS (NCT NCT03113656)
NCT ID: NCT03113656
Last Updated: 2019-09-19
Results Overview
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.
COMPLETED
NA
16 participants
baseline and 30 minutes
2019-09-19
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
7
|
|
Overall Study
COMPLETED
|
9
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Weighted Blanket First
n=9 Participants
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
n=7 Participants
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
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
6.89 days
STANDARD_DEVIATION 8.24 • n=9 Participants
|
4.00 days
STANDARD_DEVIATION 3.06 • n=7 Participants
|
5.63 days
STANDARD_DEVIATION 6.49 • n=16 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=9 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=9 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=16 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
9 participants
n=9 Participants
|
7 participants
n=7 Participants
|
16 participants
n=16 Participants
|
PRIMARY outcome
Timeframe: baseline and 30 minutesPopulation: Reporting Arms/Groups "per intervention"
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.
Outcome measures
| Measure |
Intervention
n=16 Participants
Weighted Blanket: Weighted blanket placed on infant for 30 minutes
|
Control
n=16 Participants
Non-Weighted Blanket: Non-Weighted blanket placed on infant for 30 minutes
|
|---|---|---|
|
Change in Finnegan Score
|
-1.5167 score on a scale
Standard Deviation 2.251
|
-0.2549 score on a scale
Standard Deviation 1.787
|
Adverse Events
Intervention
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place