effect of omt on reducing length of stay in a population ... di 9 aprile/pediatria/3-la mola...
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Effect of OMT on reducing length
of stay in a population of pre-term
infants: a randomized controlled
trial (RCT) study.
INTERNATIONAL CONGRESS OF OSTEOPATHIC MEDICINE
“Toward an integrated Medicine”
Florence, 6/9 April 2011
Emiliano La Mola D.O.
AIOT Research Institute
Pescara, Italy
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2
Newborns’ classification
Introduction
2
Term infants Pre-Term infant
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3
Important health problem
Introduction
3
Rate worldwide in 2005
12.9 million births
9.6% of all births, were
preterm.
Beck S, Wojdyla D, Say L et al The worldwide incidence of preterm birth: a systematic review of maternal
mortality and morbidity. Bull World Health Organ. 2010 Jan;88(1):31-8
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Pre-term costs and hospitalization
Introduction
• USA Study
Russell RB, Green NS, Steiner CA, et al. Cost of hospitalization for preterm and
low birth weight infants in the United States. Pediatrics. 2007 Jul;120(1):e1-9.
$5.8 billion = costs for preterm/low birth weight admissions,
47%
of the costs for all infant hospitalizations
27%
for all pediatric stays.
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OMT and newborns
Introduction
•Lack of osteopathic
studies
5
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CAM and pre-terms
Introduction
6
• CAM (i.e. massage) seems to be related to a
decrease of LOS
Field T, Diego M, Hernandez-Reif M. Preterm infant massage therapy research: a review. Infant
Behav Dev. 2010 Apr;33(2):115-24.
• No formal evidence to support
Vickers A, Ohlsson A, Lacy JB, Horsley A. Massage for promoting growth and development of
preterm and/or low birth-weight infants. Cochrane Database Syst Rev. 2004;(2):CD000390.
BUT
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Aim of the study
• Evaluate the efficacy of OMT in reducing
LOS and modifying weight gain in a
population of preterm infants.
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Study design
Materials & Methods
• Randomized control trial
• Outcomes:
• PRIMARY: study-control group mean
difference in LOS
• SECONDARY: study-control group
mean difference in weight gain
• Study period: 20 months
• OMT 2/week
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Study population
Materials & Methods
9
220 newborns
101 enrolled
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Exclusion criteria
Materials & Methods
• 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.
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Randomization
Materials & Methods
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101 preterms
47
study
group
54
control
group
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Type of treatment
Materials & Methods
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Standard medical care
Osteopathic evaluation
OMT
Standard medical care
Osteopathic evaluation
101 preterms
47
study
group
54
control
group
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Osteopathic Treatment
Materials & Methods
13
Indirect and fluidic techniques
•indirect myofascial;
•v-spread;
•balanced membranous tension;
•balanced ligamentous tension.
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Statistical analysis
•Arithmetic means and SD for the general
characteristics of study population;
•Univariate statistical tests for all differences
between study and control group;
•Multivariate linear regression for OMT on
outcomes
•α = 0.05
•R statistical program
• R Development Core Team (2009). R: A language and environment for statistical computing. R
Foundation for Statistical Computing, Vienna, Austria. ISBN 3-900051-07-0, URL http://www.R-
project.org.
14
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Baseline
Results
Study group Control group p value
N* 47 (46.5) 54 (53.5)
Gender
Male 24 (51.1) 27 (50.0) 0,92
Female 23 (49.8) 27 (50.0)
Gestational Age
Overall 34.1 (2.4)
34.1 (2.5)
> 32* 36 (76.6) 39 (72.2) 0,79
≤ 32 11 (23.4) 15 (27.8)
Weight (gr)
At birth 2088 (498.6)
2234 (730.9)
0,24
≤ 1500* 7 (14.9) 10 (18.5) 0,26
> 1500* 40 (85.1) 44 (81.5)
At recovery 1893 (496.7) 1926 (713.8) 0,59
Numbers in table are mean±s.d.; p value from t test
*n(%);p value from χ2 test
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Results
16
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Multivariate Linear Regression
Results
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LOS (d) Weight gain (gr)
β 95%c.i. p>χ2 β 95%c.i. p>χ2
gender 0,919 -1.450 3,288 0,44 -0,097 -2,728 0,782 0,28
Birth weight
(gr) -0,021 -0,023 -0,018 0,001 0,001 -0,006 0,008 0,89
Gestational
Age (w) -3,716 -4,380 0,023 0,01 0,05 0,027 1,012 0,04
Milk at
admission (ml) 0,014 0,004 -3,052 0,001 0,001 0,003 0,007 0,001
OMT -6,326 -8,687 -3,962 <0,001 0,06 -1,109 2,391 0,47
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Results - LOS
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Results - WG
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Discussion
• OMT and infants: possible role in several
fields
20
Hayden C, Mullinger B. A preliminary assessment of the impact of cranial osteopathy for the relief of
infantile colic. Complement Ther Clin Pract. 2006 May;12(2):83-90.
Vandenplas Y, Denayer E, Vandenbossche T, et al. Osteopathy may decrease obstructive apnea in
infants: a pilot study. Osteopath Med Prim Care. 2008 Jul 19;2:8.
Philippi H, Faldum A, Schleupen A, et al. Infantile postural asymmetry and osteopathic treatment: a
randomized therapeutic trial. Dev Med Child Neurol. 2006 Jan;48(1):5-9.
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Conclusion
• The present study shows that OMT is
independently associated to a statistical
significant reduction in LOS in a
population of pre-term infants.
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Emiliano La Mola D.O. AIOT Research Institute
Pescara, Italy
Dott. Cozzolino Vincenzo D.O., Dott.ssa Barlafante Gina D.O.,
Cerritelli Francesco D.O., Ciardelli Francesco D.O.