Trial record 8 of 28 for:    Open Studies | "Cervical Vertebrae"

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
  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

Further study details as provided by A.T. Still University of Health Sciences:

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)
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.

  Eligibility

Ages Eligible for Study:   up to 72 Hours
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01496872

Contacts
Contact: Erica Waddington, D.O. 660-626-2304 EWaddington@atsu.edu
Contact: Karen T. Snider, D.O. 660-626-2304 KSnider@atsu.edu

Locations
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.         
Sponsors and Collaborators
A.T. Still University of Health Sciences
Investigators
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 April 23, 2014