A multicenter, randomized, controlled trial of osteopathic manipulative treatment on preterms.

BACKGROUND: Despite some preliminary evidence, it is still largely unknown whether osteopathic manipulative treatment improves preterm clinical outcomes. MATERIALS AND METHODS: The present multi-center randomized single blind parallel group clinical trial enrolled newborns who met the criteria for gestational age between 29 and 37 weeks, without any congenital complication from 3 different public neonatal intensive care units. Preterm infants were randomly assigned to usual prenatal care (control group) or osteopathic manipulative treatment (study group). The primary outcome was the mean difference in length of hospital stay between groups. RESULTS: A total of 695 newborns were randomly assigned to either the study group (n= 352) or the control group (n=343). A statistical significant difference was observed between the two groups for the primary outcome (13.8 and 17.5 days for the study and control group respectively, p<0.001, effect size: 0.31). Multivariate analysis showed a reduction of the length of stay of 3.9 days (95% CI -5.5 to -2.3, p<0.001). Furthermore, there were significant reductions with treatment as compared to usual care in cost (difference between study and control group: 1,586.01€; 95% CI 1,087.18 to 6,277.28; p<0.001) but not in daily weight gain. There were no complications associated to the intervention. CONCLUSIONS: Osteopathic treatment reduced significantly the number of days of hospitalization and is cost-effective on a large cohort of preterm infants.

Osteopathic manipulative treatment and pain in preterms: study protocol for a randomised controlled trial.

BACKGROUND: Recent evidence proved the necessity to improve health care and pain management in newborns. Osteopathic manipulative treatment (OMT) has been largely used to treat painful syndromes as well as term and preterm newborns. Recent studies have demonstrated positive results of osteopathy in reducing length of stay and costs. However, no trials were carried out on pain in newborns. The aim of the present clinical trial is to explore the effectiveness of osteopathic treatment in reducing pain in a sample of preterms. METHODS/DESIGN: A three-armed single blinded placebo-control randomised controlled trial protocol has been designed to primarily evaluate the extent to which OMT is effective in reducing pain in preterms. One hundred and twenty newborns will be enrolled from one tertiary neonatal intensive care unit in central Italy and randomised in three groups: study, sham and control. The study group will be further prospectively randomised in two subgroups: experienced osteopaths and students. All preterms will receive standard medical care. Osteopathic treatment will be applied to the study group only whilst 'soft touch' will be administer to the sham group only. Newborns will undergo manual sessions once a week for the entire period of hospitalisation. Blinding will be assured for neonatal staff and outcome assessor. Primary outcome will be the mean difference in baseline score changes of PIPP questionnaire between discharge and entry among the three groups. Secondary outcomes will be: mean difference in length of stay and costs between groups. Statistical analyses will use per-protocol analysis method. Missing data will be handled using last observation carried forward imputation technique. DISCUSSION: The present single blinded randomised controlled trial has been designed to explore potential advantages of OMT in the management of newborns' pain. Currently, based on a patient-centred need-based approach, this research will be looking at the benefit of osteopathic care rather than the efficacy of a specific technique or a pre-determined protocol. TRIAL REGISTRATION: The protocol has been registered on ClinicalTrials.gov ( NCT02146677 ) on 20 May 2014.

Osteopathic evaluation of somatic dysfunction and craniosacral strain pattern among preterm and term newborns.

CONTEXT: Palpatory skills are a central part of osteopathic manipulative treatment and palpatory diagnosis. The aim of osteopathic structural examination is to locate somatic dysfunction and cranial strain pattern, which are the hallmarks that form the basis for treatment decisions and strategy. In the osteopathic literature, there is a lack of studies evaluating preterm or term newborns during hospitalization. OBJECTIVE: To determine the prevalence of somatic dysfunction and cranial strain pattern in a population of preterm and term newborns who were treated in a neonatal intensive care unit (NICU). METHODS: During a period of 6 months--November 2009 through April 2010--the authors performed a retrospective review of data on consecutive preterm and term newborns who were admitted to the NICU of the Spirito Santo Public Hospital. Osteo pathic evaluation was performed once on each newborn, and somatic dysfunction and cranial strain pattern were identified. Descriptive analysis and test of association based on the χ(2) test were performed. RESULTS: One hundred fifty-five preterm and term newborns met the study's eligibility criteria. The highest rate of somatic dysfunction was found in the pelvic area of 63 newborns (40.7%). The sacroiliac joints were compressed unilaterally or bilaterally in 82 newborns (52.9%); the lumbosacral junction was restricted in 61 newborns (39.4%), and intraosseous lesions of the sacral bone were diagnosed in 57 newborns (36.8%). The spine accounted for somatic dysfunction in 38 newborns (24.5%), with the middle thoracic and lower thoracic areas restricted in 29 (18.7%) and 21 (16.8%) newborns, respectively. Sphenobasilar synchondrosis compression and lateral-vertical strain were diagnosed in 57 newborns (36.8%), with the sagittal and the coronal sutures found restricted in 35 (22.6%) and 30 (19.4%) newborns, respectively. The occipital bone presented the highest rate of intraosseous lesions, with the left condyle compressed in 48 newborns (31%), the right condyle in 46 newborns (29.7%), and the squama in 38 newborns (24.5%). CONCLUSION: Results showed that osteopathic findings are not secondary to gestational age and weight at birth.

Effect of osteopathic manipulative treatment on gastrointestinal function and length of stay of preterm infants: an exploratory study.

BACKGROUND: Organizational improvement of neonatal intensive care units requires strict monitoring of preterm infants, including routine assessment of physiological functions of the gastrointestinal system and optimized procedures for the definition of appropriate discharge timing. METHODS: We conducted a prospective study on the effect of osteopathic manipulative treatment in a cohort of N = 350 consecutive premature infants admitted to a neonatal intensive care unit without any major complication between 2005 and 2008. In addition to ordinary care, N = 162 subjects received osteopathic treatment. Endpoints of the study were differences between study and control groups in terms of excessive length of stay and gastrointestinal symptoms, defined as the upper quartiles in the distribution of the overall population. Statistical analysis was based on crude and adjusted odds ratios from multivariate logistic regression. RESULTS: Baseline characteristics were evenly distributed across treated/control groups, except for the rate of infants unable to be oral fed at admission, significantly higher among those undergoing osteopathic care (p = .03). Osteopathic treatment was significantly associated with a reduced risk of an average daily occurrence of gut symptoms per subject above .44 (OR = 0.45; 0.26-0.74). Gestational age lower or equal to 32 weeks, birth weight lower or equal to 1700 grams and no milk consumption at admission were associated with higher rates of length of stay in the unit of at least 28 days, while osteopathic treatment significantly reduced such risk (OR = 0.22;0.09-0.51). CONCLUSIONS: In a population of premature infants, osteopathic manipulative treatment showed to reduce a high occurrence of gastrointestinal symptoms and an excessive length of stay in the NICU. Randomized control studies are needed to generalize these results to a broad population of high risk newborns.