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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
Sponsor:
Information provided by (Responsible Party):
Alexa Craig, MaineHealth

Tracking Information
First Submitted Date  ICMJE November 7, 2017
First Posted Date  ICMJE December 20, 2017
Last Update Posted Date May 31, 2019
Actual Study Start Date  ICMJE October 24, 2017
Actual Primary Completion Date April 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2017)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE OMT to Improve Feeding After Hypothermia
Official Title  ICMJE Pilot Study Assessing the Effect of Osteopathic Manipulative Treatment (OMT) on Length of Stay in Infants With Neonatal Encephalopathy After Therapeutic Hypothermia
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
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
Condition  ICMJE
  • Neonatal Encephalopathy
  • Feeding; Difficult, Newborn
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: OMT group
Osteopathic Manipulative Therapy (OMT); two treatments between day 4 and 7 of life
Intervention: Procedure: Osteopathic Manipulative Treatment (OMT)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 19, 2017)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 30, 2019
Actual Primary Completion Date April 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 37 Weeks and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03380013
Other Study ID Numbers  ICMJE IRB 1134889-1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Alexa Craig, MaineHealth
Study Sponsor  ICMJE MaineHealth
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alexa Craig, MD MaineHealth
PRS Account MaineHealth
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP