Model-Base Estimation of Non-Invasive Ventilation Weaning of Preterm Infants Exposed to Osteopathic Manipulative Treatment: A Propensity-Score-Matched Cohort Study

Participants

• Number: 40 infants (19 female and 21 male)
• Criteria of inclusion: very preterm birth (26 to 32 weeks gestation), very low birth weight (< 2,000 grams), support for non-invasive ventilation. The infants could be singletons or twins.
• Criteria of exclusion: major congenital malformations, severe neurological diseases (eg, intraventricular hemorrhage, cerebral palsy), severe cardiovascular disease, trigeminal twins, children treated with intubation.
• Groups of study: 2 groups matched by a propensity score based on perinatal demographic and clinical parameters (sex, antenatal steroids, gestational age, birth weight, Apgar score 5 minutes after birth)
  • Group 1: standard of care plus OMT, 21 infants (10 female and 11 male, gestational age 31.6 weeks)
  • Group 2: standard of care, 20 infants (10 female and 10 male, gestational age 31.5 weeks)

Interventions and evaluations

• The infants were followed until the moment of dismissal.
• Collection carried out by health professionals of the following data: demographics and data related to clinical events and to ventilation on a daily basis
  • sex, antenatal steroids, gestational age, birth weight, body length, cranial circumference, Apgar score 1 and 5 minutes after birth; number of infants for gestational age (SGA); type of non-invasive ventilation; episodes of apnea, bronchopulmonary dysplasia, respiratory distress or patent ductus arteriosus.
• Assessment of the time taken by each infant to reach weaning from ventilation, measured in days from the beginning of non-invasive ventilation to complete independence from it.
• 30-minute-OMT sessions performed from day 1 to 5 after birth, and then twice a week until discharge from hospital
  • sessions ended upon the occurrence of: arterial oxygen saturation < 0.85; more than 3 apneas; heart rate of less than 100 or more than 150 beats per minute.
• OMT: treatment based on somatic dysfunction variability model
  • evaluation of the quality of movement and mobility in the three dimensions, evaluation of the quality of the myofascial tissue, evaluation of the tenderness to touch
  • definition of the presence and severity of somatic dysfunction
  • cranial, visceral and myofascial release techniques based on somatic dysfunction
• OMT performed by pediatric osteopaths with at least 3 years of experience in neonatal intensive care.

Results

• Primary outcomes: considering that all infants reached weaning from non-invasive ventilation, the group exposed to OMT needed less time to achieve autonomous breathing. This result was maintained even after correcting the analysis for potential covariates (clinical events, sex, Apgar score 5 minutes after birth, very low birth weight, gestational age and presence of apnea).
• Secondary outcomes: gestational age and birth weight showed a negative correlation with the time needed to achieve autonomous breathing. Specifically, the higher the gestational age and the greater the weight at birth, the less time was taken for weaning from ventilator support. For children born with gestational age less than 32 weeks, receiving OMT has favored a further reduction in time to autonomous breathing. The group exposed to the OMT showed lower LOS but the result was not statistically significant.
• Further analysis: the two groups were not different for clinical events (respiratory distress or other).
  Of the 299 sessions of total OMT, only 2 were interrupted due to the occurrence of critical conditions, as a result of which no permanent adverse conditions were reported.
  The diaphragmatic region was the most treated, followed by the abdominal region and areas requiring craniosacral techniques.

Discussion

Receiving OMT and having a higher gestational age seem to correlate with an early weaning in a condition of non-invasive ventilation, favoring the establishment of autonomous breathing in preterm infants. The effect of OMT is all the greater the more infants are preterm, particularly when they are less than 32 weeks pregnant. The OMT does not seem to have the same effect with particularly underweight children at birth.

Although non-invasive ventilation is increasingly being used as it prevents chronic lung disease and leads to less oxidative stress, it is sometimes unable to guarantee good lung development in case of prematurity (both at the lung level and at the level of neuromuscular development of the diaphragm). And, indeed, the infants recruited in the study showed diaphragm and abdomen as critical areas in need of treatment.

The OMT could positively affect the attainment of autonomous respiration through a direct action on the somatosensory system: specifically, stimulating the afferent pathways present in the myofascial tissues could affect the thalamocortical pathways that regulate the total neuromuscular activity favoring a better development.

There are of course some limitations: first, it was not possible to gather accurate information on the therapeutic plan (pharmacological administration) of children, which may have affected both the creation of the two groups and the effect of OMT itself. Secondly, the OMT used is not very generalizable and repeatable, both because it involved particularly experienced operators and because the treatment was customized. Finally, as a retrospective study, a number of useful data related to ventilator and cardiovascular parameters of relevance were missing.

Therefore, we need larger, randomized controlled experimental studies, with biological data that can provide hypotheses or explanations about the potential effect of OMT.

However, an important result of the study is that it found virtually no adverse effects, thus confirming the safety of OMT as a therapeutic approach in neonatal intensive care.