Prematurity
Conditions
Keywords
pathology, newborn, osteopathic manipulative treatment, pain
Brief summary
The aim of the present 3 armed placebo control parallel group randomized control trial is to explore the extent to which osteopathic manipulative treatment is effective in reducing pain in a population of complicated newborns.
Interventions
OTHERosteopathic manipulative treatment
OTHERsham therapy
OTHERusual care
Sponsors
European Institute for Evidence Based Osteopathic Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
26 Weeks to 40 Weeks
Healthy volunteers
No
Inclusion criteria
* newborns born in the same hospital * either gender * diagnosis of any pathological/clinical medical condition
Exclusion criteria
* lack of guardian consent * newborn transferred to/from other hospital * lack of any of the inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| baseline changes in pain score using Premature Infant Pain Profile | baseline and end of hospitalization, expected hospitalization 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Length of stay in days | participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
Other
| Measure | Time frame |
|---|---|
| Neonatal Intensive Care Unit cost | participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
Countries
Italy
Contacts
Primary ContactFrancesco Cerritelli
Outcome results
None listed