Objective and endpoints of the study
To evaluate the efficacy of OMT on premature infants during hospitalization. Endpoints of the study were differences between study and control groups in terms of changes in gastrointestinal function and LOS.
Primary endpoints were measured over the entire period of NICU hospitalization as follows:
High frequency of gut symptoms, defined as the upper quartile of the average number of episodes of vomit, regurgitation, GR and enema per measurement visit per subject.
Excess duration of LOS, defined as the upper quartile of LOS in NICU per subject.
Study Design and Population
The study was based on a non randomized, longitudinal observational design investigating outcomes in a cohort of newborns admitted to the NICU of the main public hospital in Pescara, Abruzzo, Italy.
Eligible subjects included all infants consecutively admitted between January 2005 to June 2008 (N = 663). A total of N = 359 passed the following exclusion criteria: GA less than 29 weeks, or greater than 37 weeks; osteopathic treatment performed more than 14 days after birth; newborn transferred to/from other hospital/unit; newborn from an HIV seropositive and/or drug addicted mother; newborn with any of the following clinical conditions: 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. Among the 304 subjects excluded, 232 infants had a GA below 29 or above 37, while 78 subjects presented with severe clinical conditions.
After enrollment, 4 additional infants were dropped because of an unrecorded birth weight, and 5 infants (2 from the study group; 3 from the control group) because of complications arising during hospitalization.
The final total number of infants analyzed in this study was 350.
A total of 188 preterm infants were non-randomly assigned to routine neonatal care; while 162 subjects received routine care plus OMT. All patients from both groups were transferred from the delivery and/or operating room to the NICU immediately after birth.
No prior manipulation provided by any physical and/or massage therapist was performed on any infant.
Data collection was performed by undergraduate osteopaths from the Accademia Italiana Osteopatia Tradizionale (AIOT). Measurements were recorded twice a week (Tuesdays and Fridays) based upon NICU's clinical charts completed by nursing staff who provided care on the same day.
Additional infant information was included: date of birth, admission/discharge from NICU, GA at birth (based on best obstetrical estimate), birth weight at admission and discharge, formula and/or breast milk intake volume. Gastrointestinal function was measured as regurgitation (defined as the passage of refluxed gastric contents into the oral pharynx), or vomiting (defined as the expulsion of the refluxed gastric contents from the mouth, i.e. feeding tolerance), or GR finding (milky, bilious and bloody; measured only on infants with oro/naso-gastric tube, recorded as present/not present), frequency of stooling and enema administration per patient care encounter. A neurological/developmental evaluation at entry/discharge was not available for this study as it does not constitute part of routine assessment in the NICU.
Data were directly entered on an Excel spreadsheet
Osteopathic Manipulative Treatment
Osteopathic treatment was administered to the intervention group on Tuesdays and Fridays. Subjects in the study arm received osteopathic care within 14 days after birth, regardless of the application of any other procedure (i.e. mechanical ventilation, blood transfusion or phototherapy).
OMT was performed by a group of osteopaths certified by the Registro degli Osteopati d'Italia with at least five years of clinical experience.
Treatment duration ranged between 20-30 minutes. The infant's entire body was evaluated and manipulative procedures were provided as indicated by the osteopathic palpatory structural examination results. Osteopaths performing OMT were trained to use only indirect and fluidic techniques which included: indirect myofascial, sutural spread, balanced membranous tension and balanced ligamentous tension (according to teachings of William Garner Sutherland, DO, and others ).
Clinical procedures and discharge strategy
Feeding regimen, feeding strategies and enema administration were based on the application of standard international guidelines to both study arms [13, 15]. As distinct from UK/US hospitals, enema prescription used by the study NICU included five percent glucose glycerin enemas (10:1 mixture, 5 mL/kg), administered twice a day, until infants spontaneously expel at least 1 stool per day.
Physiological conditions required for discharge included: maintenance of body heat at room temperature, coordinated sucking, swallowing, and breathing while feeding; sustained pattern of weight gain; and stability of cardiorespiratory function (no episodes of apnea/bradycardia for 2-5 days, free of supplemental oxygen support) .
Main results are expressed in terms of odds ratios between each level of a potential risk factor and a set reference category (R.C.), with primary endpoints classified as binary outcomes (low/high).
Potential confounders included the following characteristics (categories): gender, GA (≤ 32; > 32- ≤ 35; > 35 weeks), birth weight (≤ 1700; > 1700- ≤ 2200; > 2200 grams), oral feeding at admission (No/Yes).
Univariate statistical tests included formal tests of the differences between study and control groups using chi-square for categorical variables and unpaired t-tests for continuous measurements.
Multivariate logistic regression was used to estimate the independent effect of OMT on primary outcomes, simultaneously adjusting for all potential confounders. Statistical significance was based on a probability level (α) equal to 0.05. Results were expressed in terms of point estimates (odds ratios: OR) and 95% confidence intervals (C.I.). All analyses were performed using the statistical programming language R .