View Clinical Trial (Medical Research Study)
Newborn Cranial Somatic Dysfunction - An Observational Study
| City: |
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Kirksville |
| State: |
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Missouri |
| Zip Code: |
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63501 |
| Conditions: |
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Somatic Dysfunction of Cranial Region - Somatic Dysfunction of Cervical Spine - Somatic Dysfunction of Lumbar Spine - Somatic Dysfunction of Sacrum |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT01496872 |
| Primary Contact: |
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Principal Investigator
Erica Waddington, D.O.
A. T. Still University
Erica Waddington, D.O.
Phone: 660-626-2304
Email: EWaddington@atsu.edu
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| Backup Contact: |
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Email: KSnider@atsu.edu
Karen T. Snider, D.O.
Phone: 660-626-2304
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| Location Contact: |
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Kirksville, Missouri 63501
United States
Kenneth L. Pamperin, M.S.
Phone: 660-626-2444
Email: KPamperin@atsu.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 19, 2013 |
| Modifications to this listing: |
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