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Newborn Cranial Somatic Dysfunction - An Observational Study

Newborn Cranial Somatic Dysfunction - An Observational Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01496872
Enrollment
100
Registered
2011-12-21
Start date
2011-08-31
Completion date
2014-08-31
Last updated
2018-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Somatic Dysfunction of Cervical Spine, Somatic Dysfunction of Cranial Region, Somatic Dysfunction of Lumbar Spine, Somatic Dysfunction of Sacrum

Keywords

Newborn cranial somatic dysfunction, Newborn observational study, Somatic dysfunction, Cranial strain pattern, Osteopathy

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.

Interventions

None listed

Sponsors

A.T. Still University of Health Sciences
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Hours to 72 Hours
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Somatic Dysfunction Scale Score (SDSS)Newborns were examined between 6 an 72 hours postnatalHealthy 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026