OMT to Improve Feeding After Hypothermia

Not Applicable

Completed

• Conditions: Feeding; Difficult, Newborn; Neonatal Encephalopathy
• Interventions: Procedure: Osteopathic Manipulative Treatment (OMT)

• Registration Number: NCT03380013
• Lead Sponsor: MaineHealth

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 Timeline

• Study Start: 2017-10-24
• Study First Submitted: 2017-11-07
• Study First Submitted QC: 2017-12-19
• Study First Posted: 2017-12-20
• Primary Completion: 2018-04-30
• Study Completion: 2019-04-30
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-29
• Last Update Posted: 2019-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OMT group	Osteopathic Manipulative Treatment (OMT)	Osteopathic Manipulative Therapy (OMT); two treatments between day 4 and 7 of life

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Maine Medical Center; 🇺🇸 Portland, Maine, United States