The Focus of the Study is to Provide a Guideline on Osteopathic Approach in Treating Hospitalized Newborns.NCT01902563
Osteopathic Approach Into Neonatology Ward: the NE-O Model
A study testing Osteopathic Manipulative Treatment in people with The Focus of the Study is to Provide a Guideline on Osteopathic Approach in Treating Hospitalized Newborns., run by European Institute for Evidence Based Osteopathic Medicine.
Trial summary
Background Several studies have shown the effect of osteopathic manipulative treatment on neonatal care in reducing length of stay, gastrointestinal problems, clubfoot complications and improving cranial asymmetry of infants affected by plagiocephaly. Read more about this study
- Who is it for?
- Ages 29 to 40 weeks
- Conditions the study is for
- The Focus of the Study is to Provide a Guideline on Osteopathic Approach in Treating Hospitalized Newborns.
- What is being tested?
- Osteopathic Manipulative Treatment
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 29 to 40 weeks
- All sexes
- Child
Who may be able to join
- newborn admitted to neonatal intensive care unit
- informed consent signed from parent or legal guardian
Who cannot join
- post surgery patients
Trial locations and contacts
No sites are listed yet.
About this study
Background Several studies have shown the effect of osteopathic manipulative treatment on neonatal care in reducing length of stay, gastrointestinal problems, clubfoot complications and improving cranial asymmetry of infants affected by plagiocephaly. Despite several results obtained, there is still lack of standardized osteopathic evaluation and treatment procedures for newborns recovered in neonatal intensive care unit (NICU).
The aim of this research is to provide a guideline on osteopathic approach in treating hospitalized newborns. Specific evaluation tests and treatments have been developed to tailor osteopathic method according to preterm and term infants' needs, NICU environment, medical and paramedical assistance.
- Being tested
- Osteopathic Manipulative Treatment
- Keywords
- osteopathic manipulative treatment, newborns, preterm infants, procedures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Manipulative TreatmentOther
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Focus of the Study is to Provide a Guideline on Osteopathic Approach in Treating Hospitalized Newborns.Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- European Institute for Evidence Based Osteopathic Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01902563
- Sponsor's protocol ID
- NE-O-prot
- Status last verified
- May 2014
- First submitted
- 10 Jul 2013
- Last updated
- 19 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteopathic Approach Into Neonatology Ward: the NE-O Model
- ClinicalTrials.gov ID
- NCT01902563
- Acronym / sponsor ID
- NE-O-prot
- Keywords
- osteopathic manipulative treatment, newborns, preterm infants, procedures
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- European Institute for Evidence Based Osteopathic MedicineUniversity, hospital or other
- First posted
- 18 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background Several studies have shown the effect of osteopathic manipulative treatment on neonatal care in reducing length of stay, gastrointestinal problems, clubfoot complications and improving cranial asymmetry of infants affected by plagiocephaly. Despite several results obtained, there is still lack of standardized osteopathic evaluation and treatment procedures for newborns recovered in neonatal intensive care unit (NICU).
The aim of this research is to provide a guideline on osteopathic approach in treating hospitalized newborns. Specific evaluation tests and treatments have been developed to tailor osteopathic method according to preterm and term infants' needs, NICU environment, medical and paramedical assistance.
Study design
Who may qualify
- Ages
- 29 to 40 weeks
- Sex
- All
- Age groups
- Child
Key inclusion criteria (2 listed)
- newborn admitted to neonatal intensive care unit
- informed consent signed from parent or legal guardian
Key exclusion criteria (1 listed)
- post surgery patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic Manipulative Treatment | Other | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic Manipulative Treatment in people with The Focus of the Study is to Provide a Guideline on Osteopathic Approach in Treating Hospitalized Newborns., run by European Institute for Evidence Based Osteopathic Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesco Cerritelli, MS, DO (+393394332801, francesco.cerritelli@ebom.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2014.