Francesca Galiano
27/12/2023 - Last update 27/12/2023

Kira Bendixen, Alexis Beinlich, Bryan Beck, Nabeel Hashmi, Alexa Craig | Year 2021

Pilot study assessing the effect of osteopathic manipulative treatment (OMT) on length of stay in neonates after therapeutic hypothermia


Term infants treated with therapeutic hypothermia

Type of study:

Pilot study

Date of publication of the study’:



Purpose of the study

  • Objective: evaluate whether OMT can reduce days of hospitalization in term infants by accelerating the transition to independent feeding (breast or bottle).
  • Measured outcomes:
    • Primary: number of days of hospitalization (LOS)
    • Secondary: assessment of the number of days required to reach independent feeding by counting days with nasogastric feeding, and assessment of somatic dysfunction by osteopathic structural assessment.


  • Number: 48 infants (17 females and 31 males).
  • Criteria of inclusion: term infants (gestational age ≥ 37 months), diagnosed with mild or moderate neonatal encephalopathy, treated with therapeutic hypothermia, no signs of seizures, normal functional brain MRI.
  • Criteria of exclusion: neonatal abstinence syndrome, fetal growth restriction, major congenital anomalies (eg, cleft lip), history of maternal diabetes, moribund state (low likelihood of benefiting from intensive support).
  • Groups of study:
    • Group 1: OMT, 12 infants (4 females and 8 males, mean gestational age 39.5 weeks).
    • Group 2: historical control with only standard of care, 36 infants (13 females and 23 males, mean gestational age 39.8 weeks):
      • 3 infants in group 2 were matched with each of the infants in group 1, on the basis of: sex, gestational age, degree of encephalopathy, absence of seizures and normal functional MRI;
    • no infants in group 1 were intubated while 19 infants in group 2 were intubated as a respiratory support measure.

Interventions and evaluations

  • Assessment of LOS as the difference between date of discharge and date of birth (equal to date of admission), calculated in whole days.
  • Evaluation of the number of days needed to reach independent feeding by counting days with nasogastric feeding.
    • Achieving independent feeding (breast or bottle feeding) was defined as a period of at least 24 hours without a nasogastric tube.
  • Evaluation of somatic dysfunction by osteopathic structural assessment before and after treatment.
    • Comments from nursing staff and parents were also collected.
  • 2 OMT sessions between days 4 and 7, and additional biweekly sessions on non-consecutive days in case of prolonged hospitalization.
    • OMT was always performed after therapeutic hypothermia.
    • on average, the duration of OMT was between 8 and 20 minutes.
  • OMT: osteopathic structural assessment to detect mainly somatic dysfunctions and non-physiological tension patterns at the craniosacral level
    • Evaluation of head and cervical, thoracic, lumbar, sacral, pelvic, and rib cage regions.
    • Techniques used at operator’s discretion, including: myofascial release, balanced ligamentous tension, balanced membranous tension, osteopathic cranial manipulative medicine.
  • OMT was performed by three operators.


  • Primary outcome: infants in the OMT group were hospitalized for 9.1 days compared with 11.6 days in the historical control group.
    Taking a part the intubated infants from the analysis, the remaining infants in the control group were hospitalized for 10.1 days, still more than the infants in the OMT group but without reaching statistical significance.
  • Secondary outcomes: in terms of the time required to achieve independent feeding, both groups had a median NG tube duration use of 2.5 days, with all infants discontinuing nasogastric feeding upon discharge and switching to bottle feeding, breastfeeding or both, with non-significant differences.
    Regarding the presence of somatic dysfunction, at the last treatment there were fewer patterns of occipital and temporal compression and an increase in physiological tension at the sphenobasilar synchondrosis (increased free and full primary respiratory motion) and in the motion of the sacral region.
    Nursing staff and parents noted an improvement in independent feeding abilities in the infants.


OMT was shown to have the potential to reduce the number of days of hospitalization of term infants treated with therapeutic hypothermia. However, this result must be considered carefully since, by removing infants intubated for respiratory needs from the analysis of the study, the effect of OMT was small.

This does not detract from the fact that, given the positive psychosocial effects on the family and the monetary savings of even 1 fewer day of hospitalization, the results of this study on a larger sample size and through a randomized controlled setting are worth further investigation.

While the two groups showed no objective changes on the duration of nasogastric feeding, both parents and nurses reported an improvement in the child’s ability to feed orally after OMT. This discrepancy could depend on the way the duration of nasogastric feeding was assessed, ie, in whole days, a mode that may have prevented noticing changes between meals.

Results regarding patterns of somatic dysfunction before and after OMT were in line with studies in the literature performed in both neonates and adults. Given the vulnerability of the neonatal skull to compressive forces, which could alter nerve conduction and thus subsequent neurodevelopment, the ability of OMT to restore patterns of physiological tension becomes essential.

The review of Osteopedia

By Marco Chiera

Strengths: calculation of sample size (how many infants to include in the study); sensitivity analysis on primary outcome by removing intubated infants; good description of the importance of paying attention to patterns of craniosacral dysfunction and their repercussions.

Limits: at the sample selection stage, a more thorough analysis of possible confounding factors should have been carried out in order to avoid removing 40% of the sample from the analysis; typo in reporting the statistical significance of the primary outcome (it is unclear whether the p-value is less than 0.05 as reported in the abstract and discussions or greater than 0.05 as reported in the Results section).

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