Effect of Osteopathic Manipulative Treatment on Pain in Preterms
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prematurity
- Sponsor
- European Institute for Evidence Based Osteopathic Medicine
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- changes from baseline in pain using Premature Infant Pain Profile (PIPP)
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
changes from baseline in pain using Premature Infant Pain Profile (PIPP)
Time Frame: baseline and end of hospitalization, average length of hospitalization expected 4 weeks
Secondary Outcomes
- Number of days of length of stay(participants will be followed for the duration of hospital stay, an expected average of 4 weeks)