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Brain Characteristics Noted Prior to and Following Treatment

NCT ID: NCT02392195

Last Updated: 2020-12-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-28

Study Completion Date

2020-09-30

Brief Summary

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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.

Detailed Description

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A dramatic increase in the number of infants diagnosed with Deformational Plagiocephaly (DP) has been observed worldwide since institution of the American Academy of Pediatrics' Back to Sleep Program. According to one published report, the incidence of DP ranges between 3-48%; this translates into120,000-2 million infants/year who develop DP in the United States alone. Some healthcare providers believe that DP is a purely cosmetic condition. This mindset undermines the importance of prevention and correction. In New Zealand, a recent study demonstrated that 39% of children without corrective action had persistent DP at age 3 to 4 years. Additionally, several studies have demonstrated associations between impaired social interactions, developmental problems and DP.Thus some researchers now believe that there may be a spectrum of untoward outcomes from brain remodeling resulting from DP. Recent technological advances now allow the detection of diminutive changes in brain structure. In this multidisciplinary descriptive pilot study we will use brain MRI (Magnetic Resonance Imaging) and a cerebral tissue oxygenation monitor, namely Frequency Domain Near Infrared and Diffuse Correlation Spectroscopy (FDNIR/DCS) to describe if differences in brain structure and characteristics exist in infants with significant DP before and after correction of the deformational defect. This study will enable investigators to seek preliminary evidence that brain development is influenced by the shape of the cranial vault, and that changes in brain structure and characteristics occur with helmet therapy. Additionally this study will help to determine the need for a larger investigation of this phenomenon that would further establish an association between DP and developmental delay.

Conditions

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Nonsynostotic Plagiocephaly

Keywords

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Plagiocephaly

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Non-interventional

Intervention Type OTHER

Observational

Interventions

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Non-interventional

Observational

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

8 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Michele DeGrazia

Director Nursing Research NICU

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michele DeGrazia, PhD, RN, NNP

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

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Children's Hospital Boston

Boston, Massachusetts, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IRB-P00004233

Identifier Type: -

Identifier Source: org_study_id