Status:
COMPLETED
OMT to Improve Feeding After Hypothermia
Lead Sponsor:
MaineHealth
Conditions:
Neonatal Encephalopathy
Feeding; Difficult, Newborn
Eligibility:
All Genders
37+ years
Phase:
NA
Brief Summary
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 mani...
Detailed Description
Infants affected by neonatal encephalopathy (NE) have been shown to have better survival rates and improved long term neurodevelopment following treatment with therapeutic hypothermia. However, a barr...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 24 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2019
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03380013
Start Date
October 24 2017
End Date
April 30 2019
Last Update
May 31 2019
Active Locations (1)
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1
Maine Medical Center
Portland, Maine, United States, 04102