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.

The Effect of Optimally Timed Osteopathic Manipulative Treatment on Length of Hospital Stay in Moderate and Late Preterm Infants: Results from a RCT.

Introduction. Little research has been conducted looking at the effects of osteopathic manipulative treatment (OMT) on preterm infants. Aim of the Study. This study hypothesized that osteopathic care is effective in reducing length of hospital stay and that early OMT produces the most pronounced benefit, compared to moderately early and late OMT. A secondary outcome was to estimate hospital cost savings by the use of OMT. Methods. 110 newborns ranging from 32- to 37-week gestation were randomized to receive either OMT or usual pediatric care. Early, moderately early, and late OMT were defined as <4, <9, and <14 days from birth, respectively. Result. Hospital stay was shorter in infants receiving late OMT (-2.03; 95% CI -3.15, -0.91; P < 0.01) than controls. Subgroup analysis of infants receiving early and moderately early OMT resulted in shorter LOS (early OMT: -4.16; -6.05, -2.27; P < 0.001; moderately early OMT: -3.12; -4.36, -1.89; P < 0.001). Costs analysis showed that OMT significantly produced a net saving of €740 (-1309.54, -170.33; P = 0.01) per newborn per LOS. Conclusions. This study shows evidence that the sooner OMT is provided, the shorter their hospital stay is. There is also a positive association of OMT with overall reduction in cost of care.

Liofilchem(®) Chromatic VRE and vancomycin MIC Test Strip detected glycopeptide resistance in a vanB neonatal Enterococcus faecium isolate showing alternate vancomycin susceptibility and resistance with bioMérieux Vitek2.

A 1-month old neonate urine sample yielded vanB Enterococcus faecium; nevertheless, the isolate alternatively showed susceptibility and resistance to vancomycin with bioMérieux Vitek2 (cards AST592, AST632, AST586), while glycopeptide resistance was detected by Liofilchem(®) vancomycin MIC Test Strip and disc along with the Chromatic VRE chromogenic medium. This communication emphasizes that, as vanB gene may be heterogeneously expressed within a given Enterococcus population, glycopeptide resistance may be missed when using automated systems for antibiotic susceptibility testing. We suggest therefore that vancomycin in vitro activity be studied on all clinical isolates through agar methods, including use of chromogenic media.

Successful off-label use of the Cepheid Xpert GBS in a late-onset neonatal meningitis by Streptococcus agalactiae.

We report the case of a late-onset neonatal meningitis by Streptococcus agalactiae (group B Streptococcus - GBS) that was diagnosed with a latex agglutination assay (on cerebrospinal fluid, CSF), as well as by using, for the first time, Xpert GBS (Cepheid, US) on CSF. Due to empirical antibiotics given before sampling, both CSF and blood culture were negative, so the abovementioned diagnostics was crucial. Moreover, the Xpert GBS assay, performed according to an off-label, modified protocol (the system is designed for GBS-carriage intrapartum screening, based on a completely automated real time-Polymerase Chain Reaction) quickly detected the organism's genome target. Although further investigation on this test's performace on CSF is required, then, we trust it may be a promising, quick and precise diagnostic method for infections in newborns.

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 length of stay in a population of preterm infants: a randomized controlled trial.

BACKGROUND: 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 improvements in several clinical outcomes. The aim of the present study is to investigate the effect of OMT on LOS in premature infants. METHODS: A randomized controlled trial was conducted on preterm newborns admitted to a single NICU between 2008-2009. N=110 subjects free of medical complications and with gestational age >28 and < 38 weeks were enrolled and randomized in two groups: study group (N=55) and control group (N=55). All subjects received routine pediatric care and OMT was performed to the study group for the entire period of hospitalization. Endpoints of the study included differences in LOS and daily weight gain. RESULTS: Results showed a significant association between OMT and LOS reduction (mean difference between treated and control group: -5.906; 95% C.I. -7.944, -3.869; p<0.001). OMT was not associated to any change in daily weight gain. CONCLUSIONS: The present study suggests that OMT may have an important role in the management of preterm infants hospitalization. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01544257.

Effectiveness of osteopathic manipulative treatment in neonatal intensive care units: protocol for a multicentre randomised clinical trial.

INTRODUCTION: Neonatal care has been considered as one of the first priorities for improving quality of life in children. In 2010, 10% of babies were born prematurely influencing national healthcare policies, economic action plans and political decisions. The use of complementary medicine has been applied to the care of newborns. One previous study documented the positive effect of osteopathic manipulative treatment (OMT) in reducing newborns' length of stay (LOS). Aim of this multicentre randomised controlled trial is to examine the association between OMT and LOS across three neonatal intensive care units (NICUs). METHODS AND ANALYSIS: 690 preterm infants will be recruited from three secondary and tertiary NICUs from north and central Italy and allocated into two groups, using permuted-block randomisation. The two groups will receive standard medical care and OMT will be applied, twice a week, to the experimental group only. Outcome assessors will be blinded of study design and group allocation. The primary outcome is the mean difference in days between discharge and entry. Secondary outcomes are difference in daily weight gain, number of episodes of vomit, regurgitation, stooling, use of enema, time to full enteral feeding and NICU costs. Statistical analyses will take into account the intention-to-treat method. Missing data will be handled using last observation carried forward (LOCF) imputation technique. ETHICS AND DISSEMINATION: Written informed consent will be obtained from parents or legal guardians at study enrolment. The trial has been approved by the ethical committee of Macerata hospital (n°22/int./CEI/27239) and it is under review by the other regional ethics committees. RESULTS: Dissemination of results from this trial will be through scientific medical journals and conferences. TRIAL REGISTRATION: This trial has been registered at http://www.clinicaltrials.org (identifier NCT01645137).

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.