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Premie Pouch to Manage Deformational Plagiocephaly in Very Low Birth Weight Infants

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ClinicalTrials.gov Identifier: NCT03184441
Recruitment Status : Completed
First Posted : June 12, 2017
Results First Posted : August 14, 2018
Last Update Posted : March 19, 2019
Sponsor:
Collaborator:
Boston Orthotics & Prosthetics
Information provided by (Responsible Party):
Michele DeGrazia, Boston Children’s Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Plagiocephaly
Intervention Device: Premie Pouch
Enrollment 11
Recruitment Details Recruitment was from 3 study sites (i.e. Neonatal Intensive Care Units). 6/30/16-7/30/16.
Pre-assignment Details  
Arm/Group Title Premie Pouch
Hide Arm/Group Description

All participants will received the experimental treatment with the Premie Pouch 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.

Period Title: Overall Study
Started 11
Completed 10 [1]
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
[1]
Last subject completed study
Arm/Group Title Premie Pouch
Hide Arm/Group Description

All participants will receive the experimental treatment with the Premie Pouch 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.

Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
10
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Days
Number Analyzed 10 participants
17.9
(5 to 38)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
2
  20.0%
Male
8
  80.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
 100.0%
Cranial Abnormalities Were Measured at Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants
10
1.Primary Outcome
Title Safety of Use of the Premie Pouch in VLBW Infants
Hide Description Frequency of participants with adverse events reported using the Premie Pouch Adverse Event Data Collection Tool.
Time Frame From date of enrollment to date of study completion (range 19-47 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with adverse events
Arm/Group Title All Subjects Recieved the Study Device
Hide Arm/Group Description:
Clinical decompensation of one subject, not device related, and not included in analysis. Did not meet minimal data requirement.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: participants
0
2.Secondary Outcome
Title Feasibility of Use of the Premie Pouch in VLBW Infants
Hide Description Documented hours per day (24 hours) on the Premie Pouch device
Time Frame Number of hours per each 24 hour period on the device
Hide Outcome Measure Data
Hide Analysis Population Description
Hours on device per day
Arm/Group Title Premie Pouch
Hide Arm/Group Description:

All participants will received the experimental treatment with the Premie Pouch 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.

Overall Number of Participants Analyzed 10
Mean (Full Range)
Unit of Measure: hours per day
20.1
(14.2 to 23.3)
3.Secondary Outcome
Title Number of Participants With Normal Cranial Index
Hide Description 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.
Time Frame Cranial index at study completion
Hide Outcome Measure Data
Hide Analysis Population Description
Normal cranial index at study completion
Arm/Group Title Premie Pouch
Hide Arm/Group Description:

All participants will received the experimental treatment with the Premie Pouch 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.

Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
5
  50.0%
4.Secondary Outcome
Title Number of Participants With Normal Cranial Symmetry
Hide Description 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.
Time Frame Cranial symmetry at study completion
Hide Outcome Measure Data
Hide Analysis Population Description
Normal Cranial Symmetry
Arm/Group Title All Subjects Recieved the Study Device
Hide Arm/Group Description:

All participants will received the experimental treatment with the Premie Pouch 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.

Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
10
 100.0%
5.Secondary Outcome
Title Premie Pouch Ease of Use
Hide Description This the percentage or nurses that found the Premie Pouch device easy to use.
Time Frame From date of enrollment to date of study completion (range 19-47 days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Premie Pouch
Hide Arm/Group Description:
Nurses caring for participants in the study
Overall Number of Participants Analyzed 23
Measure Type: Count of Participants
Unit of Measure: Participants
18
  78.3%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Premie Pouch
Hide Arm/Group Description

All participants will received the experimental treatment with the Premie Pouch 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.

All-Cause Mortality
Premie Pouch
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Premie Pouch
Affected / at Risk (%)
Total   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Premie Pouch
Affected / at Risk (%)
Total   0/10 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Michele DeGrazia
Organization: Boston Children's Hospital
Phone: 617-919-1222
Responsible Party: Michele DeGrazia, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT03184441     History of Changes
Other Study ID Numbers: IRB-P00011098
First Submitted: April 28, 2017
First Posted: June 12, 2017
Results First Submitted: January 23, 2018
Results First Posted: August 14, 2018
Last Update Posted: March 19, 2019