An interventional study of Osteopathic Manipulative Treatment (OMT) in Neonatal Encephalopathy and Feeding; Difficult, Newborn, sponsored by MaineHealth. Completed at 1 site in United States. Open to participants aged 37 Weeks and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-31.
Sponsored by MaineHealth · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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
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
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.
Time frame: 4-6 weeks
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.
Time frame: 4-6 weeks
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
MaineHealth