Prematurity
Conditions
Keywords
prematurity, newborns, pain, cost
Brief summary
Osteopathic manipulative treatment (OMT) has been used to treat term and preterm newborns. Recent studies demonstrated the effectiveness of OMT in reducing length of stay and costs (Cerritelli, 2013) as well as the likelihood of gastrointestinal episodes (Pizzolorusso 2011). Moreover it was reported the absence of adverse events and side effects considering the approach safe (Cerritelli 2013, 2014). OMT was extensively used to treat, prevent and manage pain symptoms. Numerous research was published addressing acute and chronic pain in different medical conditions. However, no trials were carried out on pain in newborns. The aim of the present clinical trial is to explore the effectiveness of OMT in reducing pain in a sample of preterm infants.
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 37 Weeks
Healthy volunteers
No
Inclusion criteria
* preterm infants * written informed consent by parents or legal guardians * preterms born in the same hospital
Exclusion criteria
* Gestational age \> 37 weeks * genetic disorders * congenital disorders * cardiovascular abnormalities * proven or suspected necrotized enterocolitis with or without gastrointestinal perforation * proven or suspected abdominal obstruction * pre/post surgery patients * pneumoperitoneum * atelectasis * Newborn from an HIV seropositive/drug addicted mother * respiratory disorders * transferred to/from other hospital * admitted for preterminal comfort care (defined as neither intubation nor cardio-respiratory resuscitation)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| changes from baseline in pain using Premature Infant Pain Profile (PIPP) | baseline and end of hospitalization, average length of hospitalization expected 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Number of days of length of stay | 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, DO
Outcome results
None listed