OMT to Improve Feeding After Hypothermia


The goal of this study is to determine if infants with neonatal encephalopathy will achieve full oral feeds faster after therapeutic hypothermia has completed if they are treated with osteopathic manipulative treatment. The treated infants will be compared to matched historical controls.

Study Start Date

October, 24 2017

Estimated Completion Date

April 2018


  • Procedure: Osteopathic Manipulative Treatment (OMT)

Study ID

Maine Medical Center -- IRB 1134889-1



Trial ID


Study Type


Trial Phase


Enrollment Quota



Maine Medical Center

Inclusion Criteria

  • Neonate > 37 weeks gestational age at birth
  • Neonate been diagnosed with neonatal encephalopathy or hypoxic ischemic encephalopathy and treated with therapeutic hypothermia
  • Neonate with mild to moderate encephalopathy
  • EEG without seizure activity
  • Brain MRI without basal ganglia injury

Exclusion Criteria

  • Neonate < 37 weeks gestational age at birth
  • Neonate with severe encephalopathy (as defined by Sarnat)
  • EEG demonstrated seizure activity or evidence of status epilepticus during therapeutic hypothermia treatment
  • Brain MRI demonstrating moderate or severe basal ganglia injury
  • Neonate affected by neonatal abstinence syndrome (NAS)
  • Neonate affected by intrauterine growth restriction (IUGR)
  • Neonate born with major congenital anomalies (i.e., cleft palate)
  • Prenatal history of maternal insulin dependent gestational or type 1 diabetes
  • Moribund status (i.e., infants unlikely to benefit from or are not responsive to aggressive life support)




37 Weeks and older

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Maine Medical Center - Portland, Maine 99.0 miles Alexa K Craig MD 207-396-7337 provides clinical trial listings in an easy to view format. All clinical trial information is pulled directly from This website does not guarantee acceptance into any clinical trial, and is not responsible for adverse events that may be incurred from a clinical trial.