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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
Sponsor:
Information provided by (Responsible Party):
A.T. Still University of Health Sciences

Study Description
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Brief Summary:
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 or disease
Somatic Dysfunction of Cranial Region Somatic Dysfunction of Cervical Spine Somatic Dysfunction of Lumbar Spine Somatic Dysfunction of Sacrum

Detailed Description:
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.

Study Design
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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
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   up to 72 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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
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Information from the National Library of Medicine

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


Locations
United States, Missouri
A. T. Still University/Northeast Regional Medical Center
Kirksville, Missouri, United States, 63501
Sponsors and Collaborators
A.T. Still University of Health Sciences
Investigators
Principal Investigator: Erica Waddington, D.O. A. T. Still University
  Study Documents (Full-Text)

Documents provided by A.T. Still University of Health Sciences:
Study Protocol and Statistical Analysis Plan  [PDF] July 21, 2011
Informed Consent Form  [PDF] July 21, 2011

More Information
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Publications:
Carreiro J. Labor, delivery and birth. In: Carreiro, J. An Osteopathic Approach to Children, 2nd ed. Edinburgh: Churchill Livingstone Elsevier, 2009: 131-145.

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     History of Changes
Other Study ID Numbers: 100721-001
First Posted: December 21, 2011    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: September 2018

Keywords provided by A.T. Still University of Health Sciences:
Newborn cranial somatic dysfunction
Newborn observational study
Somatic dysfunction
Cranial strain pattern
Osteopathy