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Completed

NCT Number: NCT03380013

OMT to Improve Feeding After Hypothermia

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.

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Key information

Age range

37 week and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maine Medical Center

Portland, Maine, 04102, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

MaineHealth

Other

Registry information

Official study title

Pilot Study Assessing the Effect of Osteopathic Manipulative Treatment (OMT) on Length of Stay in Infants With Neonatal Encephalopathy After Therapeutic Hypothermia

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Dec 20, 2017
Registry last updated
May 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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