Umbilical Cord Blood Proteomic Analysis and Neonatal Brain Injury

NCT00375908 | Completed

• 1 other identifier: 861
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypoxia-Ischemia, Brain; Periventricular Leukomalacia

Keywords

Neonatal Encephalopathy; Hypoxic-Ischemic Brain Injury; Umbilical Cord Blood; Proteomics

Outcome Measures

Primary Outcomes (1)

• Umbilical Cord Blood Proteomic Analysis and Neonatal Brain Injury

  2 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study looked at umbilical cord blood from normal neonates and neonates with risk factors for neurological injury.

You may qualify if:

• Less than 34 weeks gestational age or more than 34 weeks with a risk factor for brain injury such as chorioamnionitis, nonreassuring fetal heart rate tracing, metabolic acidosis, or hypotonia at birth.

You may not qualify if:

• Major congenital or chromosomal abnormalities in fetus

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287-1164, United States

Location

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain; Leukomalacia, Periventricular

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Encephalomalacia; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Ernest M Graham, M.D.

  Johns Hopkins Medicine, Dept Gyn-Ob

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 11, 2006
• First Posted: September 13, 2006
• Study Start: October 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: September 1, 2015

Record last verified: 2015-08

Locations

US (1)