Effect of Osteopathic Manipulative Treatment on Length of Stay in Preterms

Phase 4

Completed

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

• Registration Number: NCT01544257
• Lead Sponsor: European Institute for Evidence Based Osteopathic Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2012-02
• Study First Submitted: 2012-02-23
• Study First Submitted QC: 2012-02-28
• Last Update Submitted: 2012-02-28
• Study First Posted: 2012-03-05
• Last Update Posted: 2012-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OMT	osteopathic manipulative treatment	patients under standard medical care plus OMT.
Control	Usual care	patients under standard medical care plus only osteopathic evaluation

Primary Outcome Measures

Name	Time	Method
evaluate the effectiveness of OMT in reducing LOS	participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Francesco Cerritelli; 🇮🇹 Pescara, Italy