Newborn Cranial Somatic Dysfunction - An Observational Study

NCT01496872 | Completed

• 1 other identifier: 100721-001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Somatic Dysfunction of Cranial Region; Somatic Dysfunction of Cervical Spine; Somatic Dysfunction of Lumbar Spine; Somatic Dysfunction of Sacrum

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 6 Hours - 72 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• A.T. Still University of Health Sciences: lead

Study Sites (1)

A. T. Still University/Northeast Regional Medical Center

Kirksville, Missouri, 63501, United States

Location

Related Publications (3)

• 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.

  PMID: 5178520 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 26501758 DERIVED

Study Officials

• Erica Waddington, D.O.

  A. T. Still University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2011
• First Posted: December 21, 2011
• Study Start: August 1, 2011
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: September 27, 2018

Record last verified: 2018-09

Locations

US (1)