Clinical Trials Logo

Clinical Trial Summary

This observational study will assess long-term functional outcome of survivors from neonatal encephalopathy who were previously treated with either head cooling or with conventional care in a randomized clinical trial. Children's parents will be interviewed by phone by trained staff using the WeeFIM questionnaire to ascertain the childrens' functional performance on a set of skills basic to daily life. This instrument is able to assess a very wide range of abilities, from independently functioning to needing total assistance. The ratings will be used to examine the relationship between the outcome previously measured at 18 months age and functional outcome at school age and to triage the children into those who clearly could not be tested on standardized exams of cognitive functioning, those who potentially could, even if at a low level of cognitive ability, and those who appear to be functioning at an age-appropriate level.


Clinical Trial Description

Previous studies have demonstrated that hypothermia for hypoxic-ischemic encephalopathy in the neonatal period is generally safe and feasible, and can improve intermediate term survival without handicap. There is, however, no information on whether cooling improves longer term (school-age) outcomes in non-handicapped survivors. The current observational trial is designed to help obtain additional followup information on children who participated in the initial randomized clinical trial of head-cooling for neonatal encephalopathy. A first step is to collect information on the current status (at 7-8 years of age) of participants in the original study using a standardized telephone questionnaire. This will allow the investigators to more appropriately target children for whom further, more detailed, in-person neurodevelopmental testing would be appropriate. Given limited resources, identification of children for whom such testing would be helpful and instructive is a necessary goal. ;


Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT00581581
Study type Observational
Source University of Rochester
Contact
Status Completed
Phase N/A
Start date September 2007
Completion date October 2009

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
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
Completed NCT03380013 - OMT to Improve Feeding After Hypothermia N/A
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