Clinical Trials Logo

Clinical Trial Summary

The investigators propose to compare the proteomic analysis of umbilical venous blood from neonates with brain injury to gestational age matched noninjured controls. After delivery an umbilical arterial gas and a 10 ml umbilical venous sample are obtained, then the remainder of the cord blood is discarded. The investigators plan to use this cord blood that would otherwise be discarded to perform our proteomic analysis. The investigators will use up to 20 ml of cord blood per delivery. This will be a 5 year study during which time the investigators hope to analyze 450 infants at Johns Hopkins Hospital and Bayview Medical Center. The investigators will obtain an umbilical venous sample from infants born at < 34 weeks gestation. For infants born at > 34 weeks the investigators will obtain an umbilical venous sample for any infant suspected to be at risk for neurologic injury by having a diagnosis of chorioamnionitis during labor, nonreassuring fetal heart rate tracing at the time of delivery, or a 5 minute Apgar < 7. For the infants born at < 34 weeks the brain injured infants will be compared to gestational age matched controls without brain injury. For the infants born at > 34 weeks, each infant later confirmed to have neurologic morbidity will be compared to a gestational age matched noninjured control. The investigators hope to use proteomic analysis to determine if there are measurable differences in protein expression between the 2 groups.


Clinical Trial Description

We will draw up to 20 ml of umbilical venous blood at the time of delivery from infants born at < 34 weeks gestation, and for any infant born at > 34 weeks suspected to be at risk for neurologic morbidity by having intrapartum chorioamnionitis, nonreassuring fetal heart tracing prior to delivery, or a 5 minute Apgar < 7. For each infant born at > 34 weeks later confirmed to have neurologic morbidity by head ultrasound or EEG we will draw cord blood from a gestational age matched control without intrapartum infection or nonreassuring fetal heart tracing prior to delivery. At the time of delivery an umbilical arterial gas and umbilical venous sample for a type and screen, RPR and hematocrit are routinely drawn. The remainder of the cord blood is discarded. After the routinely done arterial blood gas and umbilical venous blood sample are obtained the remainder of the umbilical cord blood, which would otherwise be discarded, will be collected using a 23 gauge or larger needle into a heparinized tube. The sample will be centrifuged for 10 minutes and the plasma layer separated. The sample will be placed into 1.5 ml eppendorf tubes in 500 ul aliquots. Proteomic techniques including mass spectrometry, 2-dimensional electrophoresis, and chromatography, will be used to analyze the proteome from the brain injured and control groups. Specific proteins will be identified, and differences in expression compared between the 2 groups. ;


Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT00375908
Study type Observational
Source Johns Hopkins University
Contact
Status Completed
Phase N/A
Start date October 2005
Completion date December 2008

See also
  Status Clinical Trial Phase
Terminated NCT01192776 - Optimizing (Longer, Deeper) Cooling for Neonatal Hypoxic-Ischemic Encephalopathy(HIE) N/A
Completed NCT01092637 - The TOBY Children Study N/A
Completed NCT00006516 - Home Stimulation for Brain-Asphyxiated Infants Phase 2
Recruiting NCT05390060 - Delineating Between Pathophysiologic Phenotypes of Hypoxic Ischemic Brain Injury After Cardiac Arrest N/A
Completed NCT02605733 - The Neu-Prem Trial: Neuromonitoring of Preterm Newborn Brain During Birth Resuscitation
Completed NCT00005772 - Whole-Body Cooling for Birth Asphyxia in Term Infants Phase 3
Completed NCT02991976 - Oxygen Concentration and Recovery After Carotid Endarterectomy N/A
Recruiting NCT06081283 - Antiseizure Medication in Seizure Networks at Early Acute Brain Injury Phase 4
Enrolling by invitation NCT06168071 - Transauricular Vagus Nerve Stimulation in Children N/A
Completed NCT03112486 - Out-of-hospital Cardiac Arrest (OHCA) Biomarkers
Completed NCT01793129 - Preemie Hypothermia for Neonatal Encephalopathy N/A
Recruiting NCT04217551 - Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients N/A
Completed NCT04261335 - The Clinical Trial of CL2020 Cells for Neonatal Hypoxic Ischemic Encephalopathy Phase 1
Not yet recruiting NCT05514665 - Functional Imaging of Baby Brains
Recruiting NCT06048796 - Early Cessation of Sedation and TTM in Patients With a Favourable EEG After Cardiac Arrest N/A
Completed NCT03543371 - Neuropsychological Outcome After Cardiac Arrest
Not yet recruiting NCT06139250 - Development of a High-speed Multimodal Photoacoustic/Ultrasound System for Functional Imaging of the Neonatal Brain
Recruiting NCT04198792 - Predictors for Survival and Good Neurological Outcome in E-CPR and Non CPR Treated Patients
Completed NCT01483495 - Assessing Cerebrovascular Reactivity Based on Cerebral Oximetry: a Pilot Study
Completed NCT03941015 - Tissue Oxygenation During Treatment of Infant Congenital Heart Defects