Newborn Cranial Somatic Dysfunction - An Observational Study
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ClinicalTrials.gov Identifier: NCT01496872 |
Recruitment Status :
Completed
First Posted : December 21, 2011
Last Update Posted : September 27, 2018
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Condition or disease |
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Somatic Dysfunction of Cranial Region Somatic Dysfunction of Cervical Spine Somatic Dysfunction of Lumbar Spine Somatic Dysfunction of Sacrum |
Study Type : | Observational |
Actual Enrollment : | 100 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Newborn Cranial Somatic Dysfunction - An Observational Study |
Study Start Date : | August 2011 |
Actual Primary Completion Date : | August 2014 |
Actual Study Completion Date : | August 2014 |
- Somatic Dysfunction Scale Score (SDSS) [ Time Frame: Newborns were examined between 6 an 72 hours postnatal ]Healthy newborns ages 6 to 72 hours postnatal were physically examined and assessed for somatic dysfunction including asymmetry and motion restriction of the cranium, cervical, lumbar, and sacral regions. Total somatic dysfunction identified was summarized in a somatic dysfunction severity scale (SDSS) by assigning one point for each identified findings. SDSS could range from 0 (no somatic dysfunction) to 34 (all somatic dysfunctions assessed were present). Findings were compared to maternal, newborn, and delivery characteristics. Descriptive analyses and comparisons between the initial newborn assessment and research physical examination were performed.

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Ages Eligible for Study: | 6 Hours to 72 Hours (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- The infant must have been born at NRMC
- 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:
- Born outside NRMC
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01496872
United States, Missouri | |
A. T. Still University/Northeast Regional Medical Center | |
Kirksville, Missouri, United States, 63501 |
Principal Investigator: | Erica Waddington, D.O. | A. T. Still University |
Documents provided by A.T. Still University of Health Sciences:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | A.T. Still University of Health Sciences |
ClinicalTrials.gov Identifier: | NCT01496872 |
Other Study ID Numbers: |
100721-001 |
First Posted: | December 21, 2011 Key Record Dates |
Last Update Posted: | September 27, 2018 |
Last Verified: | September 2018 |
Newborn cranial somatic dysfunction Newborn observational study Somatic dysfunction Cranial strain pattern Osteopathy |
Pathologic Processes |