Pilot Study Assessing the Effect of Osteopathic Manipulative Treatment (OMT) on Length of Stay in Infants With Neonatal Encephalopathy After Therapeutic Hypothermia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- MaineHealth
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- Total hospital length of stay
Study Overview
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 manipulative treatment. The treated infants will be compared to matched historical controls.
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 barrier to hospital discharge for these infants is a successful transition from gavage to either breast or bottle feeding.
Often, the factor delaying hospital discharge is slow transition to full oral feeds. Osteopathic manipulative treatment (OMT) helps to effectively stabilize and regulate the autonomic nervous system as well as the cranial nerves important in the sucking and latching reflexes, which may in turn help to ease the transition to full oral feeding. We hypothesize that infants who receive OMT will accelerate the transition to full oral feeds, thus decreasing their overall length of hospitalization compared to historical matched controls.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 37 Weeks to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Arms & Interventions
OMT group
Osteopathic Manipulative Therapy (OMT); two treatments between day 4 and 7 of life
Intervention: Osteopathic Manipulative Treatment (OMT) (Procedure)
Outcomes
Primary Outcomes
Total hospital length of stay
Time Frame: 4-6 weeks
Assess the effect of OMT on total hospital length of stay. We will compare infants treated with OMT 1:3 with matched historical controls.
Secondary Outcomes
- Patterns of somatic dysfunction(4-6 weeks)
- Number of days until full oral feeding is achieved(4-6 weeks)
Investigators
Alexa Craig
Neonatal and Pediatric Neurologist
MaineHealth