Prospective observational study of vital sign stability and safety of Osteopathic Manipulative Treatment (OMT) in neonates

Context: Despite various publications demonstrating efficacy of osteopathic manipulative therapy (OMT) in neonates, no studies have formally assessed the safety of OMT in this population.Objective: To determine the safety of OMT in term neonates (gestational age ≥ 37 weeks) and preterm neonates (gestational age ≤ 36 6/7 weeks).Safety was assessed using two mechanisms: 1) comparison of vital signs before and after OMT, and 2) monitoring for adverse events including emesis, cyanosis, apnea or decreased level of consciousness during OMT and for 30 minutes following OMT.Methods: A prospective observational design was used to analyze pre-and post-OMT measurements of temperature, heart rate, respiratory rate and oxygen saturation.Osteopathic physicians performed an osteopathic structural exam followed by OMT using techniques such as osteopathy in the cranial field, balanced ligamentous tension and myofascial release.Adverse events were documented by a research coordinator who observed the subject directly during OMT and for 30 minutes after OMT.Results: Thirty term and 13 preterm infants were recruited for this study.The mean gestational age at birth for the term infants was 37.8 weeks and 32.5 weeks for the preterm infants.The mean gestational age at the time of treatment was 40.0 weeks for the term population and 34.9 weeks for the preterm population.In both term and pre-term infants, the temperature decreased by a statistically significant 0.1°C following OMT.Heart rate decreased by 4 beats per minute (bpm) in term subjects and by 5 bpm in preterm subjects.Respiratory rate was unchanged in term infants and increased slightly in preterm infants.There was no change in oxygen saturations for either term or preterm infants.There were no adverse events in either group. Conclusion:The stability of vital signs pre-and post-OMT and absence of adverse events in this study suggest that OMT is a safe intervention to perform in healthy, term neonates.However, due to lower than anticipated recruitment of preterm neonates, safety cannot be formally declared for this population.