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.
Somatic Dysfunction of Cranial Region
Somatic Dysfunction of Cervical Spine
Somatic Dysfunction of Lumbar Spine
Somatic Dysfunction of Sacrum
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Newborn Cranial Somatic Dysfunction - An Observational Study|
- 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.
|Study Start Date:||August 2011|
|Study Completion Date:||August 2014|
|Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01496872
|United States, Missouri|
|A. T. Still University/Northeast Regional Medical Center|
|Kirksville, Missouri, United States, 63501|
|Principal Investigator:||Erica Waddington, D.O.||A. T. Still University|