Feeding; Difficult, Newborn, Neonatal Encephalopathy
Conditions
Keywords
hypothermia treatment, OMT in infants
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.
Interventions
PROCEDUREOsteopathic Manipulative Treatment (OMT)
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.
Sponsors
MaineHealth
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Infants recruited for this study are treated with OMT upon completion of hypothermia. They are compared 1:3 with matched historical controls.
Eligibility
Sex/Gender
ALL
Age
37 Weeks to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total hospital length of stay | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of days until full oral feeding is achieved | 4-6 weeks | Assess the effect of OMT on the number of days until full oral feeding is achieved. |
| Patterns of somatic dysfunction | 4-6 weeks | 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. |
Countries
United States
Outcome results
None listed