Trial Outcomes & Findings for Premie Pouch to Manage Deformational Plagiocephaly in Very Low Birth Weight Infants (NCT NCT03184441)

Results Overview

Frequency of participants with adverse events reported using the Premie Pouch Adverse Event Data Collection Tool.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

11 participants

Primary outcome timeframe

From date of enrollment to date of study completion (range 19-47 days)

Results posted on

2019-03-19

Participant Flow

Recruitment was from 3 study sites (i.e. Neonatal Intensive Care Units). 6/30/16-7/30/16.

Participant milestones

Participant milestones
Measure	Premie Pouch 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 Study STARTED	11
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Premie Pouch 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 Study Withdrawal by Subject	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Premie Pouch n=10 Participants 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.
Age, Categorical <=18 years	10 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=10 Participants
Age, Categorical >=65 years	0 Participants n=10 Participants
Age, Continuous	17.9 days n=10 Participants
Sex: Female, Male Female	2 Participants n=10 Participants
Sex: Female, Male Male	8 Participants n=10 Participants
Region of Enrollment United States	10 Participants n=10 Participants
Cranial Abnormalities Were Measured at Enrollment	10 participants n=10 Participants

PRIMARY outcome

Timeframe: From date of enrollment to date of study completion (range 19-47 days)

Population: Participants with adverse events

Frequency of participants with adverse events reported using the Premie Pouch Adverse Event Data Collection Tool.

Outcome measures

Outcome measures
Measure	All Subjects Recieved the Study Device n=10 Participants Clinical decompensation of one subject, not device related, and not included in analysis. Did not meet minimal data requirement.
Safety of Use of the Premie Pouch in VLBW Infants	0 participants

SECONDARY outcome

Timeframe: Number of hours per each 24 hour period on the device

Population: Hours on device per day

Documented hours per day (24 hours) on the Premie Pouch device

Outcome measures

Outcome measures
Measure	All Subjects Recieved the Study Device n=10 Participants Clinical decompensation of one subject, not device related, and not included in analysis. Did not meet minimal data requirement.
Feasibility of Use of the Premie Pouch in VLBW Infants	20.1 hours per day Interval 14.2 to 23.3

SECONDARY outcome

Timeframe: Cranial index at study completion

Population: Normal 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.

Outcome measures

Outcome measures
Measure	All Subjects Recieved the Study Device n=10 Participants Clinical decompensation of one subject, not device related, and not included in analysis. Did not meet minimal data requirement.
Number of Participants With Normal Cranial Index	5 Participants

SECONDARY outcome

Timeframe: Cranial symmetry at study completion

Population: Normal Cranial Symmetry

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.

Outcome measures

Outcome measures
Measure	All Subjects Recieved the Study Device n=10 Participants Clinical decompensation of one subject, not device related, and not included in analysis. Did not meet minimal data requirement.
Number of Participants With Normal Cranial Symmetry	10 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	All Subjects Recieved the Study Device n=23 Participants Clinical decompensation of one subject, not device related, and not included in analysis. Did not meet minimal data requirement.
Premie Pouch Ease of Use	18 Participants

Adverse Events

Premie Pouch

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michele DeGrazia

Boston Children's Hospital

Phone: 617-919-1222

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place