OMT to Improve Feeding After Hypothermia

Description

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

Interventions

  • Procedure: Osteopathic Manipulative Treatment (OMT)

Study ID

Maine Medical Center -- IRB 1134889-1

Status

Unknown

Trial ID

NCT03380013

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

12

Sponsor

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)

Gender

All

Ages

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 craiga@mmc.org

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