OMT to Improve Feeding After Hypothermia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03380013
Recruitment Status : Recruiting
First Posted : December 20, 2017
Last Update Posted : December 20, 2017
Information provided by (Responsible Party):
Alexa Craig, Maine Medical Center

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.

Condition or disease Intervention/treatment Phase
Neonatal Encephalopathy Feeding; Difficult, Newborn Procedure: Osteopathic Manipulative Treatment (OMT) Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study Assessing the Effect of Osteopathic Manipulative Treatment (OMT) on Length of Stay in Infants With Neonatal Encephalopathy After Therapeutic Hypothermia
Actual Study Start Date : October 24, 2017
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia

Arm Intervention/treatment
Experimental: OMT group
Osteopathic Manipulative Therapy (OMT); two treatments between day 4 and 7 of life
Procedure: Osteopathic 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.

Primary Outcome Measures :
  1. Total hospital length of stay [ Time Frame: 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 :
  1. Number of days until full oral feeding is achieved [ Time Frame: 4-6 weeks ]
    Assess the effect of OMT on the number of days until full oral feeding is achieved.

  2. Patterns of somatic dysfunction [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   37 Weeks and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03380013

Contact: Alexa K Craig, MD 207-396-7337

United States, Maine
Maine Medical Center Recruiting
Portland, Maine, United States, 04102
Contact: Alexa K Craig, MD    207-396-7337   
Principal Investigator: Alexa K Craig, MD         
Sponsors and Collaborators
Maine Medical Center
Principal Investigator: Alexa Craig, MD Maine Medical Center
  Study Documents (Full-Text)

Documents provided by Alexa Craig, Maine Medical Center:

Responsible Party: Alexa Craig, Neonatal and Pediatric Neurologist, Maine Medical Center Identifier: NCT03380013     History of Changes
Other Study ID Numbers: IRB 1134889-1
First Posted: December 20, 2017    Key Record Dates
Last Update Posted: December 20, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alexa Craig, Maine Medical Center:
hypothermia treatment
OMT in infants

Additional relevant MeSH terms:
Brain Diseases
Body Temperature Changes
Signs and Symptoms
Central Nervous System Diseases
Nervous System Diseases