Brain Characteristics Noted Prior to and Following Treatment

NCT02392195 | Completed Results DMC

• 1 other identifier: IRB-P00004233
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study will enable investigators to find out if brain structure and characteristics are affected by the shape of the infant's head, and if changes in the brain occur with helmet therapy.

Conditions

Nonsynostotic Plagiocephaly

Keywords

Plagiocephaly

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Qualitatively Determined Normalization of White Matter Pathways

  We will compare if nerve pathways are appreciably different in the area of head flattening following helmet therapy by visual examination and comparison of areas of asymmetry vs. symmetry.

  2-6 months

Secondary Outcomes (1)

• Number of Participants With Improved Developmental Exams Post Helmet Therapy

  2-6 months

Other Outcomes (1)

• Number of Participants With Improved Cranial Asymmetry After Cranial Orthotic Treatment

  Collected retrospectively

Study Arms (1)

Single arm; Non-interventional

A convenience sample of 10-15 infants born at term gestation, that are \</= 6 months of age with significant DP (defined as head flattening requiring helmet therapy) and no major health issues will be recruited into this phase 1 descriptive pilot study

Other: Non-interventional

Interventions

Non-interventional OTHER

Observational

Single arm; Non-interventional

Eligibility Criteria

• Age: Up to 8 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Deformational Plagiocephaly in full term, healthy infants.

You may qualify if:

• \- DP requiring helmet therapy
• Term gestation at birth (37 weeks or greater)
• Less than/or equal to 8 months of age
• No history of major health problem such as birth injury, genetic disorder, intracranial hemorrhage, hydrocephalus, neurologic abnormality
• No history of implantable metal device or internal/external orthotic device

You may not qualify if:

• \- DP not requiring helmet therapy
• Premature gestation at birth (less than 37 weeks gestation).
• Greater than 8 months of age
• History of major health problem such as birth injury genetic disorder, intracranial hemorrhage, hydrocephalus, neurologic abnormality
• History of implantable metal device or internal/external orthotic device
• Infants not completing prescribed treatment for correction with a helmet

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Plagiocephaly, Nonsynostotic; 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, RN, NNP

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Nursing Research NICU

Study Record Dates

• First Submitted: March 12, 2015
• First Posted: March 18, 2015
• Study Start: February 1, 2013
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: December 10, 2020
• Results First Posted: December 10, 2020

Record last verified: 2020-12

Locations

US (1)