OMT to Improve Feeding After Hypothermia

NCT03380013 | Completed

• 1 other identifier: IRB 1134889-1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Encephalopathy; Feeding; Difficult, Newborn

Keywords

hypothermia treatment; OMT in infants

Outcome Measures

Primary Outcomes (1)

• 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.

  4-6 weeks

Secondary Outcomes (2)

• Number of days until full oral feeding is achieved

  4-6 weeks

• Patterns of somatic dysfunction

  4-6 weeks

Study Arms (1)

OMT group

EXPERIMENTAL

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

Procedure: Osteopathic Manipulative Treatment (OMT)

Interventions

Osteopathic Manipulative Treatment (OMT) PROCEDURE

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.

OMT group

Eligibility Criteria

• Age: 37 Weeks+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• MaineHealth: lead

Study Sites (1)

Maine Medical Center

Portland, Maine, 04102, United States

Location

Related Publications (5)

• 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.

  PMID: 23440789 BACKGROUND

• 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.

  PMID: 18534024 BACKGROUND

• 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.

  PMID: 21912407 BACKGROUND

• 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.

  PMID: 5178520 BACKGROUND

• 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.

  PMID: 23622070 BACKGROUND

MeSH Terms

Interventions

Manipulation, Osteopathic

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Alexa Craig, MD

  MaineHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neonatal and Pediatric Neurologist

Model Details: Infants recruited for this study are treated with OMT upon completion of hypothermia. They are compared 1:3 with matched historical controls.

Study Record Dates

• First Submitted: November 7, 2017
• First Posted: December 20, 2017
• Study Start: October 24, 2017
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2019
• Last Updated: May 31, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)