Plagiocephaly Clinical Trial
Official title:
Premie Pouch to Manage Deformational Plagiocephaly in Very Low Birth Weight Infants
NCT number | NCT03184441 |
Other study ID # | IRB-P00011098 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2016 |
Est. completion date | March 2019 |
Verified date | July 2018 |
Source | Boston Children’s Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 11 |
Est. completion date | March 2019 |
Est. primary completion date | August 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 40 Days |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital Boston | Boston | Massachusetts |
United States | St. Elizabeth's Medical Center | Brighton | Massachusetts |
United States | South Shore Hospital | Weymouth | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston Children’s Hospital | Boston Orthotics & Prosthetics |
United States,
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. — View Citation
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):941-7. doi: 10.1097/01.prs.0000299938.00229.3e. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Feasibility of Use of the Premie Pouch in VLBW Infants | Documented hours per day (24 hours) on the Premie Pouch device | Number of hours per each 24 hour period on the device | |
Secondary | Number of Participants With Normal Cranial Index | 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. | Cranial index at study completion | |
Secondary | Number of Participants With 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. | Cranial symmetry at study completion | |
Secondary | Premie Pouch Ease of Use | This the percentage or nurses that found the Premie Pouch device easy to use. | From date of enrollment to date of study completion (range 19-47 days) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05848895 -
OPT-IN: Osteopathic Plagiocephaly Treatment for Infants and Neonates
|
N/A | |
Completed |
NCT01989286 -
Postural Assessment in Plagiocephaly
|
N/A | |
Not yet recruiting |
NCT06425172 -
Monitoring System for Cranial Orthoses
|
||
Withdrawn |
NCT02561728 -
Hanger Helmet Study
|
N/A | |
Completed |
NCT03659032 -
Efficacy of Pediatric Manual Therapy in the Positional Plagiocephaly
|
N/A | |
Enrolling by invitation |
NCT02283229 -
Newborn Head Molding and Later Asymmetries
|
N/A | |
Recruiting |
NCT06173102 -
Cranial Orthosis Therapy for Plagiocephaly: an RCT Pilot Study Comparing Cranial Orthosis to the Natural Course
|
N/A | |
Completed |
NCT05004597 -
3D Craniofacial Morphologic Development of Healthy Infants
|
N/A | |
Terminated |
NCT01218087 -
Cranial Cup Use for the Prevention of Positional Head Shape Deformity in the NICU
|
N/A |