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

NCT03184441 | Completed Results DMC

• 1 other identifier: IRB-P00011098
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 3

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.

Conditions

Plagiocephaly

Outcome Measures

Primary Outcomes (1)

• Safety of Use of the Premie Pouch in VLBW Infants

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

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

Secondary Outcomes (4)

• Feasibility of Use of the Premie Pouch in VLBW Infants

  Number of hours per each 24 hour period on the device

• Number of Participants With Normal Cranial Index

  Cranial index at study completion

• Number of Participants With Normal Cranial Symmetry

  Cranial symmetry at study completion

• Premie Pouch Ease of Use

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

Study Arms (1)

Premie Pouch

EXPERIMENTAL

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

Device: Premie Pouch

Interventions

Premie Pouch DEVICE

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.

Premie Pouch

Eligibility Criteria

• Age: Up to 40 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.)
• Infants born at \>/= 22 weeks gestation.
• Infants \</= 40 days of age at enrollment.
• Infants that receive medical clearance from their healthcare team.
• Infants that have an estimated minimum hospital length of stay = / \> 14 days from the time of enrollment.
• 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.

You may not qualify if:

• 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.
• 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.
• Infants with a craniofacial anomaly, craniosynostosis, cervical anomaly, or critical airway.
• Infants with Cutis Aplasia or significant skin breakdown to the scalp, because the experimental device may worsen a preexisting condition.
• 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.

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Boston Orthotics & Prosthetics: collaborator

Study Sites (3)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

St. Elizabeth's Medical Center

Brighton, Massachusetts, 02135, United States

Location

South Shore Hospital

Weymouth, Massachusetts, 02190, United States

Location

Related Publications (3)

• Seruya M, Oh AK, Sauerhammer TM, Taylor JH, Rogers GF. Correction of deformational plagiocephaly in early infancy using the plagio cradle orthotic. J Craniofac Surg. 2013 Mar;24(2):376-9. doi: 10.1097/SCS.0b013e31828010d1.

  PMID: 23524697 BACKGROUND

• Rogers GF, Miller J, Mulliken JB. Comparison of a modifiable cranial cup versus repositioning and cervical stretching for the early correction of deformational posterior plagiocephaly. Plast Reconstr Surg. 2008 Mar;121(3):941-947. doi: 10.1097/01.prs.0000299938.00229.3e.

  PMID: 18317143 BACKGROUND

• DeGrazia M, Giambanco D, Hamn G, Ditzel A, Tucker L, Gauvreau K. Prevention of deformational plagiocephaly in hospitalized infants using a new orthotic device. J Obstet Gynecol Neonatal Nurs. 2015 Jan-Feb;44(1):28-41. doi: 10.1111/1552-6909.12523. Epub 2015 Jan 8.

  PMID: 25573141 BACKGROUND

MeSH Terms

Conditions

Plagiocephaly

Condition Hierarchy (Ancestors)

Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Michele DeGrazia
• Organization: Boston Children's Hospital

michele.degrazia@childrens.harvard.edu

617-919-1222

Study Officials

• Michele DeGrazia, PhD, NNP

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Nursing Research, Neonatal Intensive Care Unit

Study Record Dates

• First Submitted: April 28, 2017
• First Posted: June 12, 2017
• Study Start: June 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: March 1, 2019
• Last Updated: March 19, 2019
• Results First Posted: August 14, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)