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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01852500

Enrollment

250

Registered

2013-05-13

Start date

2010-11-30

Completion date

2011-04-30

Last updated

2013-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prematurity

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.

Interventions

OTHERSham Osteopathic Manipulative Treatment

Patients from this group received sham osteopathic treatments twice a week for the entire length of stay in the unit.

OTHERStandard care

Patients from control group received standard care plus osteopathic evaluation only, according to the same schedule as the study group.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

29 Weeks to 37 Weeks

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Evaluate the effectiveness of sham OMT in reducing LOS	participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Secondary

Measure	Time frame
pre-post difference in weight gain	participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026