Effectiveness Of Osteopathic Manipulative Treatment In NICU: A Multicenter Clinical Trial

Study Overview
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Brief Summary
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The use of complementary and alternative medicine in neonatal ward has been steadily rising during the last decade. This integrated medicine approach has been shown to be helpful to improve neonatal health care. Osteopathic manipulative treatment (OMT) has been applied to premature infants to reduce the length of stay and to cope with clinical complications. Results from previous studies documented the positive association between OMT and shorter period of hospitalisation as well as improvement of clinical conditions. The aim of this nationwide multicenter study is to demonstrate the effect of OMT on length of stay (LOS) in premature infants across 3 neonatal intensive care units (NICU).

Official Title
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Effectiveness Of Osteopathic Manipulative Treatment In Neonatal Intensive Care Units: A Multicenter Randomized Clinical Trial

Conditions
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Prematurity

Intervention / Treatment
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* Other: osteopathic manipulative treatment
* Other: 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 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)

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 usual medical care plus osteopathic treatment | 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>|
| Other: control<br>patients under usual medical care | Other: 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 |
| --- | --- | --- |
| Number of days of 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 | 
| number of episodes of vomit |  | participants will be followed for the duration of hospital stay, an expected average of 4 weeks | 
| days to full enteral feeding |  | participants will be followed for the duration of hospital stay, an expected average of 4 weeks | 
| NICU costs |  | participants will be followed for the duration of hospital stay, an expected average of 4 weeks | 
| number of episodes of regurgitation |  | participants will be followed for the duration of hospital stay, an expected average of 4 weeks | 
| number of episodes of stooling |  | 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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prematurity, OMT, complementary and alternative medicine, neonates, length of stay