OMT to Improve Feeding After Hypothermia

MaineHealth

Status

Completed

Conditions

Feeding; Difficult, Newborn

Neonatal Encephalopathy

Treatments

Procedure: Osteopathic Manipulative Treatment (OMT)

Study type

Interventional

Funder types

Other

Identifiers

NCT03380013

IRB 1134889-1

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 patients

Sex

All

Ages

37+ weeks old

Volunteers

Accepts Healthy Volunteers

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)