Clinical trial NCT03380013: OMT to Improve Feeding After Hypothermia
Official title: Pilot Study Assessing the Effect of Osteopathic Manipulative Treatment (OMT) on Length of Stay in Infants With Neonatal Encephalopathy After Therapeutic Hypothermia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Encephalopathy
Feeding; Difficult, Newborn
Keywords: hypothermia treatment
OMT in infants
Lead sponsor: MaineHealth
Sponsor class: OTHER
First posted: 2017-12-20
Enrollment: 12
Sex: ALL
Minimum age (years): 37
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Total hospital length of stay
timeFrame: 4-6 weeks
Secondary outcomes:
measure: Number of days until full oral feeding is achieved
timeFrame: 4-6 weeks
measure: Patterns of somatic dysfunction
timeFrame: 4-6 weeks
Other outcomes:
Locations:
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
Study officials:
affiliation: MaineHealth
name: Alexa Craig, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jacobs SE, Berg M, Hunt R, Tarnow-Mordi WO, Inder TE, Davis PG. Cooling for newborns with hypoxic ischaemic encephalopathy. Cochrane Database Syst Rev. 2013 Jan 31;2013(1):CD003311. doi: 10.1002/14651858.CD003311.pub3.
citation: Henley CE, Ivins D, Mills M, Wen FK, Benjamin BA. Osteopathic manipulative treatment and its relationship to autonomic nervous system activity as demonstrated by heart rate variability: a repeated measures study. Osteopath Med Prim Care. 2008 Jun 5;2:7. doi: 10.1186/1750-4732-2-7.
citation: Inder TE. Pediatrics: predicting outcomes after perinatal brain injury. Nat Rev Neurol. 2011 Sep 13;7(10):544-5. doi: 10.1038/nrneurol.2011.142. No abstract available.
citation: Frymann V. Relation of disturbances of craniosacral mechanisms to symptomatology of the newborn: study of 1,250 infants. J Am Osteopath Assoc. 1966 Jun;65(10):1059-75. No abstract available.
citation: Cerritelli F, Pizzolorusso G, Ciardelli F, La Mola E, Cozzolino V, Renzetti C, D'Incecco C, Fusilli P, Sabatino G, Barlafante G. Effect of osteopathic manipulative treatment on length of stay in a population of preterm infants: a randomized controlled trial. BMC Pediatr. 2013 Apr 26;13:65. doi: 10.1186/1471-2431-13-65.