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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

Tracking Information
First Submitted Date December 19, 2011
First Posted Date December 21, 2011
Last Update Posted Date September 27, 2018
Study Start Date August 2011
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 11, 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.
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Newborn Cranial Somatic Dysfunction - An Observational Study
Official Title Newborn Cranial Somatic Dysfunction - An Observational Study
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Somatic Dysfunction of Cranial Region
  • Somatic Dysfunction of Cervical Spine
  • Somatic Dysfunction of Lumbar Spine
  • Somatic Dysfunction of Sacrum
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 19, 2011)
100
Original Estimated Enrollment Same as current
Actual Study Completion Date August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 72 Hours   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01496872
Other Study ID Numbers 100721-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party A.T. Still University of Health Sciences
Study Sponsor A.T. Still University of Health Sciences
Collaborators Not Provided
Investigators
Principal Investigator: Erica Waddington, D.O. A. T. Still University
PRS Account A.T. Still University of Health Sciences
Verification Date September 2018