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Effectiveness of Repositioning and Cranial Remolding in Infants with Cranial Deformation
Study ID: STU 032017-036
Summary
a non-invasive scan and measurement will be taken of each patient at monthly visits starting at the age of 2 months and continuing until the head shape is normalized or no longer in need of treatment. Patient's caregivers will be educated in repositioning strategies at monthly appointments and follow up scans will be taken monthly to determine the progression of the cranial shape. Because prior studies have shown repositioning efforts are most effective in the first 2 months of attempts, and that cranial remolding orthoses effectiveness are decreased after the infant is 6 months of age, the patients included in this study will undergo repositioning efforts starting at 2 months of age and continuing to a maximum of 6 months of age, at which time any further need for cranial correction will be recommended through the use of a cranial remolding orthosis. Repositioning instructions will be given verbally by a Certified orthotist and in written form to all study participants. The repositioning instructions will be specific to the infant's head shape (left or right plagiocephaly, brachycephaly, or combined head shapes) and will be given in the form of a standardized flyer or pamphlet to each caregiver involved in the study. outcomes and duration of treatment will be varied due to different physical capabilities of the infant during normal development and the severity of the presenting head shape; however the determination of a corrected cranial shape will be standardized for all participants, whether repositioning or undergoing CRo treatment. Follow up visits during repositioning will be monthly for all participants. Follow up visits for infants undergoing cranial remolding treatment will be according to a standardized flow chart, with the only exception being if a caregiver is concerned about a problem with the orthosis or patient's skin condition, at which time an additional appointment will be added to the follow up schedule to address the caregiver's concern(s). uncontrollable variables include patients who miss appointments or drop out of the study. Per the protocol, only a certain number of missed appointments will be accepted for inclusion in the study and all participants will be required to have a final [Quote]end point[Quote] scan to show cranial correction or non-correction at the end of treatment. There may be some caregivers who choose to continuing with repositioning efforts beyond 6 months of age, if the family chooses not to proceed with a CRo. These infants will still be followed monthly to determine if repositioning alone achieves full correction of the cranial shape to a maximum of 12 months of age.
Participant Eligibility
1) healthy infants (infants may have torticollis, acid reflux, or other minor health conditions which do not affect growth rates) 2) 2 months of age who have been identified by a physician to have a deformational cranial malformation (for 3D substudy, infants who are healthy with no cranial deformation or need for physical therapy noted) 3) English speaking caretakers 4) caretaker's informed consent 5) Rx or order from physician indicating the need for repositioning and/or CRO treatment (or referral to our study for a physical therapy and head shape evaluation for the control group).
- Cancer Related
- No
- Healthy Volunteers
- No
- UT Southwestern Principal Investigator
- TIFFANY DANIELLE FOREST GRAHAM
UTSW INTERNAL
This study will examine how effective caregiver's repositioning strategies are in correcting an infant's deformational cranial shapes. if a patient does not correct through repositioning efforts, this study will further examine how effective cranial remolding orthotic treatment is for these patients. Specifically, the study will begin by measuring and scanning the head shapes of a 2 month old infant who has been identified by a physician to have a deformational head shape to determine the extent of the cranial deformity. The caregivers will be informed of specific repositioning strategies to reduce the cranial deformation and be provided with cranial measurements. The hypothesis to be tested is: 1) Caregiver repositioning strategies are effective in the treatment of cranial deformations of 2 month old infants. 2) if an infant fails 2-4 months of repositioning efforts, then a cranial remolding orthosis is an effective treatment of deformational cranial shapes in 4-6 month old infants. This study's primary focus is to determine the effectiveness of caregiver repositioning instructions on affecting deformational head shapes which are identified at 2 months of age (when pediatricians typically first screen infants for deformational shapes per aMa recommendations). Prior studies have shown varied results of repositioning efforts, all with some amount of infants not achieving full correction. For those who do not achieve correction/normalization of the head shape with repositioning, a Cranial Remolding orthosis (CRo) may be recommended for treatment, but recommendations for this form of treatment have varied among physicians and CRo's are considered non-covered services for some insurances due to a lack of published studies that this treatment can be effective. For studies which have shown CRo treatment is effective, most claim it is most effective when initiated by 6 months of age, with younger treatment ages achieving faster correction.
