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NCT Number: NCT01544257

Effect of Osteopathic Manipulative Treatment on Length of Stay in Preterms

The use of osteopathic manipulative treatment (OMT) in preterm infants has been documented and results from previous studies suggest the association between OMT and length of stay (LOS) reduction, as well as significant improvement in several clinical outcomes. The aim of the present study is to show the effect of OMT on LOS in a sample of 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

29 week–37 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Francesco Cerritelli

Pescara, 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
  • osteopathic treatment performed < 14 days after birth
  • preterms born in the same hospital

Exclusion criteria

  • gestational age < 29, > 37 weeks;
  • 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

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

Procedure

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 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

Official study title

Effect of OMT on Length of Stay in a Population of Preterm Infants: RCT Study

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 5, 2012
Registry last updated
Mar 5, 2012

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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