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OMT to Improve Feeding After Hypothermia

Primary Purpose

Neonatal Encephalopathy, Feeding; Difficult, Newborn

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Osteopathic Manipulative Treatment (OMT)

About this trial

This is an interventional treatment trial for Neonatal Encephalopathy focused on measuring hypothermia treatment, OMT in infants

Eligibility Criteria

37 Weeks - undefined (Child, Adult, Older Adult)All SexesAccepts 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)

Sites / Locations

Maine Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OMT group

Arm Description

Osteopathic Manipulative Therapy (OMT); two treatments between day 4 and 7 of life

Outcomes

Primary Outcome Measures

Total hospital length of stay

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

Number of days until full oral feeding is achieved

Assess the effect of OMT on the number of days until full oral feeding is achieved.

Patterns of somatic dysfunction

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.

Full Information

NCT ID

NCT03380013

First Posted

November 7, 2017

Last Updated

May 29, 2019

Sponsor

MaineHealth

1. Study Identification

Unique Protocol Identification Number

NCT03380013

Brief Title

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

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Completed

Study Start Date

October 24, 2017 (Actual)

Primary Completion Date

April 30, 2018 (Actual)

Study Completion Date

April 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

MaineHealth

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neonatal Encephalopathy, Feeding; Difficult, Newborn

Keywords

hypothermia treatment, OMT in infants

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

OMT group

Arm Type

Experimental

Arm Description

Osteopathic Manipulative Therapy (OMT); two treatments between day 4 and 7 of life

Intervention Type

Procedure

Intervention Name(s)

Osteopathic Manipulative Treatment (OMT)

Intervention Description

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 Measure Information:

Title

Total hospital length of stay

Description

Assess the effect of OMT on total hospital length of stay. We will compare infants treated with OMT 1:3 with matched historical controls.

Time Frame

4-6 weeks

Secondary Outcome Measure Information:

Title

Number of days until full oral feeding is achieved

Description

Assess the effect of OMT on the number of days until full oral feeding is achieved.

Time Frame

4-6 weeks

Title

Patterns of somatic dysfunction

Description

Time Frame

4-6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

37 Weeks

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alexa Craig, MD

Organizational Affiliation

MaineHealth

Official's Role

Principal Investigator

Facility Information:

Facility Name

Maine Medical Center

City

Portland

State/Province

Maine

ZIP/Postal Code

04102

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

23440789

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.

Results Reference

background

PubMed Identifier

18534024

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.

Results Reference

background

PubMed Identifier

21912407

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.

Results Reference

background

PubMed Identifier

5178520

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.

Results Reference

background

PubMed Identifier

23622070

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.

Results Reference

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OMT to Improve Feeding After Hypothermia

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