OMT to Improve Feeding After Hypothermia

Completed · Not applicable

Conditions studied: Neonatal Encephalopathy, Feeding; Difficult, Newborn

In brief

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.

Key facts

Study ID

NCT03380013

Run by

MaineHealth

People needed

12

Starts

2017-10-24

Expected to finish

2019-04-30

Last updated by the study team

2019-05-31

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Maine Medical Center — Portland, Maine, United States

Full record on ClinicalTrials.gov

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