Newborn Cranial Somatic Dysfunction - An Observational Study

Completed

• Conditions: Somatic Dysfunction of Lumbar Spine; Somatic Dysfunction of Cervical Spine; Somatic Dysfunction of Sacrum; Somatic Dysfunction of Cranial Region

• Registration Number: NCT01496872
• Lead Sponsor: A.T. Still University of Health Sciences

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.

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 Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-12-19
• Study First Submitted QC: 2011-12-19
• Study First Posted: 2011-12-21
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-26
• Last Update Posted: 2018-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Somatic Dysfunction Scale Score (SDSS)	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.

Trial Locations

Locations (1)

A. T. Still University/Northeast Regional Medical Center; 🇺🇸 Kirksville, Missouri, United States