Newborn Cranial Somatic Dysfunction - An Observational Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by A.T. Still University of Health Sciences.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
A.T. Still University of Health Sciences
ClinicalTrials.gov Identifier:
NCT01496872
First received: December 19, 2011
Last updated: NA
Last verified: November 2011
History: No changes posted

December 19, 2011
December 19, 2011
August 2011
July 2012   (final data collection date for primary outcome measure)
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Not Provided
No Changes Posted
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Newborn Cranial Somatic Dysfunction - An Observational Study
Newborn Cranial Somatic Dysfunction - An Observational Study

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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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.

  • Somatic Dysfunction of Cranial Region
  • Somatic Dysfunction of Cervical Spine
  • Somatic Dysfunction of Lumbar Spine
  • Somatic Dysfunction of Sacrum
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
up to 72 Hours
Yes
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
 
NCT01496872
100721-001
No
A.T. Still University of Health Sciences
A.T. Still University of Health Sciences
Not Provided
Principal Investigator: Erica Waddington, D.O. A. T. Still University
A.T. Still University of Health Sciences
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP