Newborn Cranial Somatic Dysfunction - An Observational Study

• ClinicalTrials.gov Identifier: NCT01496872
• Recruitment Status: Completed
• First Posted: December 21, 2011
• Last Update Posted: September 27, 2018
• Sponsor: A.T. Still University of Health Sciences
• Information provided by (Responsible Party): A.T. Still University of Health Sciences

Study Description

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.

Condition or disease
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 Design

• Study Type: Observational
• Actual Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Newborn Cranial Somatic Dysfunction - An Observational Study
• Study Start Date: August 2011
• Actual Primary Completion Date: August 2014
• Actual Study Completion Date: August 2014

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 6 Hours to 72 Hours (Child)
• Sexes Eligible for Study: All
• 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

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

  Study Documents (Full-Text)

Documents provided by A.T. Still University of Health Sciences:

Study Protocol and Statistical Analysis Plan  [PDF] July 21, 2011

Informed Consent Form  [PDF] July 21, 2011

More Information

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.

Carreiro J. Labor, delivery and birth. In: Carreiro, J. An Osteopathic Approach to Children, 2nd ed. Edinburgh: Churchill Livingstone Elsevier, 2009: 131-145.

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
• Other Study ID Numbers: 100721-001
• First Posted: December 21, 2011
• Last Update Posted: September 27, 2018
• Last Verified: September 2018

Keywords provided by A.T. Still University of Health Sciences:

Newborn cranial somatic dysfunction; Newborn observational study; Somatic dysfunction; Cranial strain pattern; Osteopathy

Additional relevant MeSH terms:

Pathologic Processes