NCT01852500
Completed
Phase 4
Are Newborns Conscious of the Placebo Effect? Result From an RCT in Osteopathy
European Institute for Evidence Based Osteopathic Medicine1 site in 1 country250 target enrollmentNovember 2010
ConditionsPrematurity
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Prematurity
- Sponsor
- European Institute for Evidence Based Osteopathic Medicine
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Evaluate the effectiveness of sham OMT in reducing LOS
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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 the present study is to evaluate the effectiveness of sham OMT in reducing LOS in a sample of preterm newborns, in order to investigate whether previous clinical results could be related to a hypothetical placebo effect.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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.
Outcomes
Primary Outcomes
Evaluate the effectiveness of sham OMT in reducing LOS
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Secondary Outcomes
- pre-post difference in weight gain(participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
Study Sites (1)
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