Clinical trial NCT01496872: Newborn Cranial Somatic Dysfunction - An Observational Study
Official title: Newborn Cranial Somatic Dysfunction - An Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: A.T. Still University of Health Sciences
Sponsor class: OTHER
First posted: 2011-12-21
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Somatic Dysfunction Scale Score (SDSS)
timeFrame: Newborns were examined between 6 an 72 hours postnatal
Secondary outcomes:
Other outcomes:
Locations:
city: Kirksville
country: United States
facility: A. T. Still University/Northeast Regional Medical Center
state: Missouri
Study officials:
affiliation: A. T. Still University
name: Erica Waddington, D.O.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Carreiro J. Labor, delivery and birth. In: Carreiro, J. An Osteopathic Approach to Children, 2nd ed. Edinburgh: Churchill Livingstone Elsevier, 2009: 131-145.
citation: 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.