Effect of Osteopathic Manipulative Treatment on Length of Stay in Preterms

Study Overview
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Brief Summary
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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.

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

Conditions
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Prematurity

Intervention / Treatment
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* Other: osteopathic manipulative treatment
* Procedure: Usual care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 29 Weeks
Maximum Age: 37 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OMT<br>patients under standard medical care plus OMT. | Other: osteopathic manipulative treatment<br>* Patients from this group received osteopathic treatments twice a week for the entire length of stay in the unit.<br>|
| No Intervention: Control<br>patients under standard medical care plus only osteopathic evaluation | Procedure: Usual care<br>* Patients from control group received standard care plus osteopathic evaluation only, according to the same schedule as the study group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pre-post difference in weight gain |  | participants will be followed for the duration of hospital stay, an expected average of 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteopathic manipulative treatment, alternative medicine, complementary medicine, neonatology, neonatal care, prematurity, allied health care