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Completed

NCT Number: NCT01784835

Early Exposure to OMT Prevents Long LOS

The application of osteopathic manipulative treatment (OMT) in preterm infants has been demonstrated to be effective in reducing length of stay (LOS). The scope of the present study is to investigate the association between earlier exposure to OMT and reduction of LOS in premature infants

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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

32 week–37 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Macerata Hospital

Province of Macerata, Macerata, 62100, 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
  • osteopathic treatment performed < 14 days after birth
  • preterms born in the same hospital

Exclusion criteria

  • Gestational age < 29 weeks
  • Gestational age > 37 weeks
  • First OMT performed after 14 days from birth
  • genetic disorders
  • congenital disorders
  • cardiovascular abnormalities
  • proven or suspected necrotized enterocolitis with or without gastrointestinal perforation proven or suspected abdominal obstruction
  • pre/post surgery patients
  • pneumoperitoneum
  • atelectasis
  • Newborn from an HIV seropositive/drug addicted mother
  • respiratory disorders
  • transferred to/from other hospital
  • admitted for preterminal comfort care (defined as neither intubation nor cardio-respiratory resuscitation)

Treatment and study plan

Osteopathic manipulative treatment

Other

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

Usual 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. Number of days of LOS

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

Secondary outcomes

  1. effectiveness of OMT considering different lag time between birth and the first OMT

    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
2012
Study completion
2012
First posted
Feb 6, 2013
Registry last updated
Feb 6, 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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