Newborn Cranial Somatic Dysfunction - An Observational Study

NCT ID: NCT01496872

Last Updated: 2018-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-31

Study Completion Date

2014-08-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

6 Hours

Maximum Eligible Age

72 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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A.T. Still University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Erica Waddington, D.O.

Role: PRINCIPAL_INVESTIGATOR

A. T. Still University

Locations

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A. T. Still University/Northeast Regional Medical Center

Kirksville, Missouri, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 5178520 (View on PubMed)

Carreiro J. Labor, delivery and birth. In: Carreiro, J. An Osteopathic Approach to Children, 2nd ed. Edinburgh: Churchill Livingstone Elsevier, 2009: 131-145.

Reference Type BACKGROUND

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.

Reference Type DERIVED
PMID: 26501758 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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100721-001

Identifier Type: -

Identifier Source: org_study_id

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