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

Brief Summary:
This pilot project proposes to develop and test a new device to manage (defined as resolving, prohibiting, inhibiting or preventing) the development of Deformational Plagiocephaly (DP) in prematurely born infants weighing < 1 kilogram.

Condition or disease Intervention/treatment Phase
Plagiocephaly Device: Premie Pouch Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 40 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Infants weighing </= 900 grams. (Selecting a weight below the 1 Kg cut off for using the device will allow the infant an opportunity to use the device before outgrowing it.)
  2. Infants born at >/= 22 weeks gestation.
  3. Infants </= 40 days of age at enrollment.
  4. Infants that receive medical clearance from their healthcare team.
  5. Infants that have an estimated minimum hospital length of stay = / > 14 days from the time of enrollment.
  6. Every effort will be made to include infants from non-English speaking families as long as using all available resources; the parents can successfully communicate with the research team. The research team will utilize interpreter services and other resources (immediate family members and supports) to facilitate this process when applicable.

Exclusion Criteria:

  1. Infants that require only prone positioning to maintain airway patency (such as those with Pierre Robin Syndrome/Sequence) will not be eligible to participate; this is because infants must be able to lie supine for at least part of the day.
  2. Infants requiring medical devices such as a continuous ventricular drain, subgaleal shunt, or intravenous catheters (unless placement of the IV is temporary) as they prevent proper positioning using the Premie Pouch.
  3. Infants with a craniofacial anomaly, craniosynostosis, cervical anomaly, or critical airway.
  4. Infants with Cutis Aplasia or significant skin breakdown to the scalp, because the experimental device may worsen a preexisting condition.
  5. Infants that are to be transferred to a non-participating hospital within 14 days of enrollment as this timeframe may not allow adequate evaluation of the Premie Pouch.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03184441

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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
Sponsors and Collaborators
Boston Children’s Hospital
Boston Orthotics & Prosthetics
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Principal Investigator: Michele DeGrazia, PhD, NNP Boston Children’s Hospital

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Responsible Party: Michele DeGrazia, Director of Nursing Research, Neonatal Intensive Care Unit, Boston Children’s Hospital Identifier: NCT03184441     History of Changes
Other Study ID Numbers: IRB-P00011098
First Posted: June 12, 2017    Key Record Dates
Results First Posted: August 14, 2018
Last Update Posted: March 19, 2019
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Birth Weight
Plagiocephaly, Nonsynostotic
Body Weight
Signs and Symptoms
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Congenital Abnormalities