Premie Pouch to Manage Deformational Plagiocephaly in Very Low Birth Weight Infants
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03184441|
Recruitment Status : Completed
First Posted : June 12, 2017
Results First Posted : August 14, 2018
Last Update Posted : March 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Plagiocephaly||Device: Premie Pouch||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Premie Pouch to Manage Deformational Plagiocephaly in Very Low Birth Weight Infants|
|Study Start Date :||June 2016|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||March 2019|
Experimental: Premie Pouch
All participants will receive the experimental treatment with the Premie Pouch device.
Device: Premie Pouch
The Premie Pouch is an experimental device meant to manage the development of Deformational Plagiocephaly (DP) starting immediately following birth. The Premie Pouch has a concave-shaped foam insert that will provide a resting surface for the infant's head and body that will eliminate uneven pressure on the infant's occiput while maintaining correct body alignment. Also, the posterior neck area of the infant will be supported by a fixed bridge section of the foam insert. The Premie Pouch is designed specifically for the very low birth weight (VLBW) infant.
- Safety of Use of the Premie Pouch in VLBW Infants [ Time Frame: From date of enrollment to date of study completion (range 19-47 days) ]Frequency of participants with adverse events reported using the Premie Pouch Adverse Event Data Collection Tool.
- Feasibility of Use of the Premie Pouch in VLBW Infants [ Time Frame: Number of hours per each 24 hour period on the device ]Documented hours per day (24 hours) on the Premie Pouch device
- Number of Participants With Normal Cranial Index [ Time Frame: Cranial index at study completion ]Cranial index (An objective front to back and side to side, measure that quantifies head shape by dividing head width by length then multiplying it by 100%) for each of participants was measured at study completion. Participants falling within the normal range of 73%-85% had normal cranial index.
- Number of Participants With Normal Cranial Symmetry [ Time Frame: Cranial symmetry at study completion ]To assess for cranial asymmetry of the head shape at study completion, the right anterior-posterior measures and left anterior-posterior measures of infant's head shapes were obtained. Cranial symmetry was defined as less than 8mm difference in the right and left anterior-posterior measures.
- Premie Pouch Ease of Use [ Time Frame: From date of enrollment to date of study completion (range 19-47 days) ]This the percentage or nurses that found the Premie Pouch device easy to use.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03184441
|United States, Massachusetts|
|Children's Hospital Boston|
|Boston, Massachusetts, United States, 02115|
|St. Elizabeth's Medical Center|
|Brighton, Massachusetts, United States, 02135|
|South Shore Hospital|
|Weymouth, Massachusetts, United States, 02190|
|Principal Investigator:||Michele DeGrazia, PhD, NNP||Boston Children’s Hospital|