OMT to Improve Feeding After Hypothermia

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.

Official Title
-----------------
Pilot Study Assessing the Effect of Osteopathic Manipulative Treatment (OMT) on Length of Stay in Infants With Neonatal Encephalopathy After Therapeutic Hypothermia

Conditions
-----------------
Neonatal Encephalopathy, Feeding; Difficult, Newborn

Intervention / Treatment
-----------------
* Procedure: Osteopathic Manipulative Treatment (OMT)


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 37 Weeks

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Infants recruited for this study are treated with OMT upon completion of hypothermia. They are compared 1:3 with matched historical controls.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OMT group<br>Osteopathic Manipulative Therapy (OMT); two treatments between day 4 and 7 of life | Procedure: Osteopathic Manipulative Treatment (OMT)<br>* Each neonate will have a structural exam completed assessing each body region (head, cervical, thoracic, lumbar, sacral, pelvic, rib cage, and abdominal regions) for underlying somatic dysfunctions prior to each treatment. The specific OMT techniques used will be left to the discretion of the treating physician and will not be based on a predetermined protocol. Treatment techniques will consist of myofascial release, balanced ligamentous tension, balanced membranous tension, and osteopathy in the cranial field. Total treatment time will be 15 minutes. The features of the osteopathic structural exam which will be recorded on paper by the treating physician at the time of the evaluation. The paper will be marked only with the research identifier.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total hospital length of stay | Assess the effect of OMT on total hospital length of stay. We will compare infants treated with OMT 1:3 with matched historical controls. | 4-6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days until full oral feeding is achieved | Assess the effect of OMT on the number of days until full oral feeding is achieved. | 4-6 weeks | 
| Patterns of somatic dysfunction | We will perform an osteopathic structural exam before and after treatment while recording the specific somatic dysfunctions observed within the medical record. We will then use these notes to perform a qualitative analysis of patterns of somatic dysfunction specific to the craniosacral mechanism before and after OMT. | 4-6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypothermia treatment, OMT in infants