Newborn Cranial Somatic Dysfunction - An Observational Study
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Purpose
Two prominent osteopathic physician researchers have studied cranial somatic dysfunction in newborns. Dr Viola Frymann published a paper in 1966 on the presence of somatic dysfunction involving 1250 infants. Dr. Jane Carreiro evaluated 1600 newborns in 1993 for cranial somatic dysfunction. This observational study is intended to continue their work in exploring the presence of cranial somatic dysfunction in newborns. The hypothesis is that there is an increased incidence of somatic dysfunction in newborns birthed by primigravid women and in newborns who experienced a longer second stage of labor.
| Condition |
|---|
|
Somatic Dysfunction of Cranial Region Somatic Dysfunction of Cervical Spine Somatic Dysfunction of Lumbar Spine Somatic Dysfunction of Sacrum |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Newborn Cranial Somatic Dysfunction - An Observational Study |
| Estimated Enrollment: | 100 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
100 newborns will be assessed for somatic dysfunction of the head, cervical, lumbar, and sacral areas. These findings will be compared to the findings of a standard newborn physical exam and the newborn and maternal history. These records will be reviewed for maternal age, parity, gravity, anesthesia during labor, and estimated gestational age. Birth history and initial newborn assessments will be reviewed for labor augmentation, duration of labor, length of second stage of labor, presence of instrumental delivery(vacuum extraction, forceps delivery, etc.), multiple birth, and presentation at delivery (breech, transverse, or compound presentation). The purpose of the study is to quantify the presence of somatic dysfunction in the newborn. We will assess any relationships between the identified somatic dysfunctions and factors present in the mother's and newborn's medical history.
Eligibility| Ages Eligible for Study: | up to 72 Hours |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Infants born at the Northeast Regional Medical Center (NRMC) in Kirksville, MO, between August 1, 2011, and July 31, 2012. The infants must be greater than 6 but less than 72 hours old to participate in the study.
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
Contacts and Locations| Contact: Erica Waddington, D.O. | 660-626-2304 | EWaddington@atsu.edu |
| Contact: Karen T. Snider, D.O. | 660-626-2304 | KSnider@atsu.edu |
| United States, Missouri | |
| A. T. Still University/Northeast Regional Medical Center | Recruiting |
| Kirksville, Missouri, United States, 63501 | |
| Contact: Kenneth L. Pamperin, M.S. 660-626-2444 KPamperin@atsu.edu | |
| Contact: Celia Hagan, BSN 660-626-2443 CHagan@atsu.edu | |
| Principal Investigator: Erica Waddington, D.O. | |
| Sub-Investigator: Karen T Snider, D.O. | |
| Sub-Investigator: Michael Lockwood, D.O. | |
| Principal Investigator: | Erica Waddington, D.O. | A. T. Still University |
More Information
No publications provided
| Responsible Party: | A.T. Still University of Health Sciences |
| ClinicalTrials.gov Identifier: | NCT01496872 History of Changes |
| Other Study ID Numbers: | 100721-001 |
| Study First Received: | December 19, 2011 |
| Last Updated: | December 19, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by A.T. Still University of Health Sciences:
|
Newborn cranial somatic dysfunction Newborn observational study Somatic dysfunction Cranial strain pattern Osteopathy |
ClinicalTrials.gov processed this record on May 16, 2013