A. T. Still University/Northeast Regional Medical Center
Kirksville, Missouri, 63501, United States
Completed
NCT Number: NCT01496872
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.
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Notify MeKey information
Conditions
Age range
6 hour–72 hour
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
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.
Sponsors and collaborators
Lead sponsor
A.T. Still University of Health Sciences
Other
Registry information
Important dates
- Study start
- 2011
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- Dec 21, 2011
- Registry last updated
- Sep 27, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.