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Updated: May 14, 2026
Assessment of the Efficacy of An Osteopathic Treatment in Infants with Biomechanical Impairments to Suckling
Published on: February 5, 2019
Effectiveness of osteopathic manipulative treatment in neonatal intensive care units: protocol for a multicentre
Francesco Cerritelli1, Gianfranco Pizzolorusso, Cinzia Renzetti
1Research and Development, EBOM-European Institute for Evidence Based Osteopathic Medicine, Chieti, Italy.
Insights
Osteopathic manipulative treatment (OMT) may reduce length of stay for preterm infants in neonatal intensive care units (NICUs). This study investigates OMT
Area of Science:
- Neonatal care
- Complementary medicine
- Clinical trials
Background:
- Neonatal care is crucial for child well-being, with 10% of births being premature in 2010.
- Complementary medicine is increasingly used in neonatal care.
- Previous research suggests osteopathic manipulative treatment (OMT) may reduce length of stay (LOS) for newborns.
Purpose of the Study:
- To evaluate the association between OMT and LOS in preterm infants.
- To assess the impact of OMT on secondary outcomes in neonatal intensive care units (NICUs).
Main Methods:
- A multicentre randomized controlled trial involving 690 preterm infants across three NICUs in Italy.
- Infants were allocated to receive standard care or standard care plus OMT twice weekly.
- Blinded outcome assessors evaluated primary outcomes (LOS) and secondary outcomes (weight gain, feeding, etc.).
Main Results:
- The study aims to determine the mean difference in LOS between the OMT and standard care groups.
- Secondary outcome analysis will include differences in daily weight gain, feeding, and NICU costs.
- Statistical analysis will follow the intention-to-treat principle with LOCF for missing data.
Conclusions:
- This trial will provide evidence on the efficacy of OMT in reducing length of stay for preterm infants.
- Findings will inform healthcare policies and practices regarding complementary therapies in neonatal intensive care.
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).
