Newborn Cranial Somatic Dysfunction - An Observational Study - Full Text View

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:

Primary Outcome Measures:

Somatic Dysfunction Scale Score (SDSS) [ Time Frame: Newborns were examined between 6 an 72 hours postnatal ] [ Designated as safety issue: No ]
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.


Enrollment:	100
Study Start Date:	August 2011
Study Completion Date:	August 2014
Primary Completion Date:	August 2014 (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 (Child)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Waddington EL, Snider KT, Lockwood MD, Pazdernik VK. Incidence of Somatic Dysfunction in Healthy Newborns. J Am Osteopath Assoc. 2015 Nov;115(11):654-65. doi: 10.7556/jaoa.2015.136.


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:	August 11, 2014
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 September 28, 2016