Status:
COMPLETED
Are Newborns Conscious of the Placebo Effect? Result From an RCT in Osteopathy
Lead Sponsor:
European Institute for Evidence Based Osteopathic Medicine
Conditions:
Prematurity
Eligibility:
All Genders
29-37 years
Phase:
PHASE4
Brief Summary
Results from previous studies suggest the association between Osteopathic Manipulative Treatment (OMT) and length of stay (LOS) reduction in a population of preterm infants. The primary objective of ...
Eligibility Criteria
Inclusion
- preterm infants born at age between 29 and 37 weeks
- sham osteopathic treatment performed \< 14 days after birth
- preterm infants born in the same hospital
Exclusion
- gestational age \< 29, \> 37 weeks;
- sham osteopathic treatment performed \> 14 days after birth;
- newborn transferred to/from other hospital;
- newborn from to HIV seropositive and/or drug addict mother;
- newborn with genetic disorders, congenital abnormalities, cardiovascular abnormalities, neurological disorders, proven or suspected necrotizing enterocolitis with or without gastrointestinal perforation, proven or suspected abdominal obstruction, pre- and/or post-surgery patients, pneumoperitoneum and/or atelectasis.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT01852500
Start Date
November 1 2010
End Date
April 1 2011
Last Update
May 13 2013
Active Locations (1)
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1
Francesco Cerritelli
Pescara, PE, Italy, 65124