Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT03380013
Study type Interventional
Source Maine Medical Center
Contact
Status Completed
Phase N/A
Start date October 24, 2017
Completion date April 30, 2019

See also
  Status Clinical Trial Phase
Completed NCT05471336 - Enteral Feeding and Splanchnic NIRS Values in Infants With Neonatal Encephalopathy (NE) N/A
Recruiting NCT05514340 - Assess Safety and Efficacy of Sovateltide in Hypoxic-ischemic Encephalopathy Phase 2
Recruiting NCT04603547 - Transcutaneous Carbon Dioxide Monitoring in Neonates Receiving Therapeutic Hypothermia for Neonatal Encephalopathy
Completed NCT01913340 - Neonatal Erythropoietin And Therapeutic Hypothermia Outcomes in Newborn Brain Injury (NEATO) Phase 1/Phase 2
Completed NCT00581581 - CoolCap Followup Study-Coordination of Participating Centers N/A
Recruiting NCT05772416 - Neonatal Neurological Examination to Detect Infants at Risk
Completed NCT03122808 - Uterine Activity in Moderate-Severe Neonatal Encephalopathy: A Case Control Study
Recruiting NCT02544100 - Neonatal Neurologic Intensive Care Network of China
Active, not recruiting NCT03409770 - Optimising the Duration of Cooling in Mild Encephalopathy N/A
Recruiting NCT05127070 - Evaluating the NeoTree in Malawi and Zimbabwe
Not yet recruiting NCT06098833 - Treatment of Neonatal Encephalopathy With Oral Sildenafil Suspension to Repair Brain Injury Secondary to Birth Asphyxia Phase 2
Not yet recruiting NCT05756296 - The Long-term Consequences of Neonatal Encephalopathy in the Hypothermia Era
Recruiting NCT04432662 - Darbepoetin in Neonatal Encephalopathy Trial Phase 2
Recruiting NCT02793999 - Perinatal Brain Injury: Potential of Innovative NIRS to Optimize Hypothermia
Not yet recruiting NCT05889507 - Cooling in Mild Encephalopathy N/A
Recruiting NCT05848271 - Natural History Study of Patients With HPDL Mutations
Not yet recruiting NCT04176471 - TIME Study: Therapeutic Hypothermia for Infants With Mild Encephalopathy N/A
Completed NCT01309711 - Magnetic Resonance Biomarkers in Neonatal Encephalopathy
Recruiting NCT04225975 - Neonate Cerebral Activity in Immediate Post Partum N/A
Recruiting NCT05610085 - A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures Phase 2