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.

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kirksville, Missouri, United States, 63501
      • A. T. Still University/Northeast Regional Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 hours to 3 days (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Somatic Dysfunction Scale Score (SDSS)	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.	Newborns were examined between 6 an 72 hours postnatal

Collaborators and Investigators

• Sponsor: A.T. Still University of Health Sciences
• Investigators: Principal Investigator: Erica Waddington, D.O., A. T. Still University

Publications and helpful links

General Publications

• Frymann V. Relation of disturbances of craniosacral mechanisms to symptomatology of the newborn: study of 1,250 infants. J Am Osteopath Assoc. 1966 Jun;65(10):1059-75. No abstract available.
• Carreiro J. Labor, delivery and birth. In: Carreiro, J. An Osteopathic Approach to Children, 2nd ed. Edinburgh: Churchill Livingstone Elsevier, 2009: 131-145.
• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (ACTUAL): August 1, 2014
• Study Completion (ACTUAL): August 1, 2014

Study Registration Dates

• First Submitted: December 19, 2011
• First Submitted That Met QC Criteria: December 19, 2011
• First Posted (ESTIMATE): December 21, 2011

Study Record Updates

• Last Update Posted (ACTUAL): September 27, 2018
• Last Update Submitted That Met QC Criteria: September 26, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Osteopathy; Newborn cranial somatic dysfunction; Newborn observational study; Somatic dysfunction; Cranial strain pattern
• Additional Relevant MeSH Terms: Pathologic Processes
• Other Study ID Numbers: 100721-001