Newborn Cranial Somatic Dysfunction - An Observational Study
NCT ID: NCT01496872
Last Updated: 2018-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
100 participants
OBSERVATIONAL
2011-08-31
2014-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* The infant must be greater than 6 hours old when enrolled
* The infant must be less than 72 hours old when enrolled
* The mother must volunteer to participate in the study
Exclusion Criteria
* Infants who are critically ill will be excluded
* Infants with open spina bifida will be excluded
* Infants with a cleft lip will be excluded
* Infants with a cleft palate will be excluded
* Children who are wards of the state will be excluded
6 Hours
72 Hours
ALL
Yes
Sponsors
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A.T. Still University of Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Erica Waddington, D.O.
Role: PRINCIPAL_INVESTIGATOR
A. T. Still University
Locations
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A. T. Still University/Northeast Regional Medical Center
Kirksville, Missouri, United States
Countries
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References
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Frymann V. Relation of disturbances of craniosacral mechanisms to symptomatology of the newborn: study of 1,250 infants. J Am Osteopath Assoc. 1966 Jun;65(10):1059-75. No abstract available.
Carreiro J. Labor, delivery and birth. In: Carreiro, J. An Osteopathic Approach to Children, 2nd ed. Edinburgh: Churchill Livingstone Elsevier, 2009: 131-145.
Waddington EL, Snider KT, Lockwood MD, Pazdernik VK. Incidence of Somatic Dysfunction in Healthy Newborns. J Am Osteopath Assoc. 2015 Nov;115(11):654-65. doi: 10.7556/jaoa.2015.136.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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100721-001
Identifier Type: -
Identifier Source: org_study_id
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