CompletedNot Applicable

Newborn Cranial Somatic Dysfunction - An Observational Study

United States100 participantsStarted 2011-08

Plain-language 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.

Who can participate

Age range

6 Hours – 72 Hours

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Somatic Dysfunction Scale Score (SDSS)

Timeframe: Newborns were examined between 6 an 72 hours postnatal

Trial details

NCT IDNCT01496872

SponsorA.T. Still University of Health Sciences

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2014-08

View on ClinicalTrials.gov More Somatic Dysfunction of Cranial Region trials