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Completed

NCT Number: NCT01852500

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

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.

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Key information

Conditions

Prematurity Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

29 week–37 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Francesco Cerritelli

Pescara, PE, 65124, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sham Osteopathic Manipulative Treatment

Other

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

Standard care

Other

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

Primary outcomes

  1. 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

  1. pre-post difference in weight gain

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Sponsors and collaborators

Lead sponsor

European Institute for Evidence Based Osteopathic Medicine

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 13, 2013
Registry last updated
May 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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