Are Newborns Conscious of the Placebo Effect? Result From an RCT in Osteopathy

European Institute for Evidence Based Osteopathic Medicine

Status and phase

Completed

Phase 4

Conditions

Prematurity

Treatments

Other: Sham Osteopathic Manipulative Treatment

Other: Standard care

Study type

Interventional

Funder types

Other

Identifiers

NCT01852500

NEO-Plac 01 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

250 patients

Sex

All

Ages

29 to 37 weeks old

Volunteers

Accepts Healthy Volunteers

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.