OMT to Improve Feeding After Hypothermia
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|ClinicalTrials.gov Identifier: NCT03380013|
Recruitment Status : Completed
First Posted : December 20, 2017
Last Update Posted : May 31, 2019
|Condition or disease||Intervention/treatment||Phase|
|Neonatal Encephalopathy Feeding; Difficult, Newborn||Procedure: Osteopathic Manipulative Treatment (OMT)||Not Applicable|
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)|
|Actual 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)|
|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|
|Actual Primary Completion Date :||April 30, 2018|
|Actual Study Completion Date :||April 30, 2019|
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.
- 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.
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT03380013
|United States, Maine|
|Maine Medical Center|
|Portland, Maine, United States, 04102|
|Principal Investigator:||Alexa Craig, MD||MaineHealth|