| Registry | NCT01496872 |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 100 (Actual) |
| Sponsor | A.T. Still University of Health Sciences (Other) |
| Conditions | Somatic Dysfunction of Cranial Region, Somatic Dysfunction of Cervical Spine, Somatic Dysfunction of Lumbar Spine, Somatic Dysfunction of Sacrum |
| Dates | start 2011-08-01, primary completion 2014-08-01, completion 2014-08-01, first posted 2011-12-21, last updated 2018-09-27 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Somatic Dysfunction of Cranial Region All trials for Somatic Dysfunction of Cervical Spine
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.
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.
Sex: All, ages: 6 Hours to 72 Hours, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| A. T. Still University/Northeast Regional Medical Center | Kirksville, Missouri | United States |