Early Exposure to OMT Prevents Long LOS

Not Applicable

Completed

• Conditions: Prematurity
• Interventions: Other: osteopathic manipulative treatment; Other: Usual care

• Registration Number: NCT01784835
• Lead Sponsor: European Institute for Evidence Based Osteopathic Medicine

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2013-02
• Study First Submitted: 2013-02-04
• Study First Submitted QC: 2013-02-04
• Last Update Submitted: 2013-02-04
• Study First Posted: 2013-02-06
• Last Update Posted: 2013-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OMT	osteopathic manipulative treatment	patients under usual medical care plus osteopathic treatment
control	Usual care	patients under standard medical care

Primary Outcome Measures

Name	Time	Method
Number of days of LOS	participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Secondary Outcome Measures

Name	Time	Method
effectiveness of OMT considering different lag time between birth and the first OMT	participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Trial Locations

Locations (1)

Macerata Hospital; 🇮🇹 Macerata, Italy