Inflammatory Cytokines Associated With Perinatal Brain Injury (Cytokines)

March 20, 2019 updated by: NICHD Neonatal Research Network

A Study to Determine If Inflammatory Cytokines Are Associated With Perinatal Brain Injury and Long Term Neurodevelopmental Handicap or Death

This observational study assessed whether measurements of certain pro-inflammatory and anti-inflammatory cytokines in the blood (either singly or in combination) at birth and/or up to day of life 21 can predict cerebral palsy at 18-22 months corrected age.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Inflammatory cytokines [interleukin-1 (IL-1β), IL-8, IL-9, tumor necrosis factor-α (TNF-α), and RANTES] but not anti-inflammatory cytokines released during the perinatal period have been associated with the development of periventricular leukomalacia (PVL) and cerebral palsy (CP) in near term and term infants. However, because blood samples were obtained on any day between day 1 and 18, these data cannot distinguish between prenatal and postnatal effects on neurological outcome. Furthermore, very low birth weight infants who are at the highest risk have not been studies.

The goal of this study was to measure pro-inflammatory and anti-inflammatory cytokine levels at various times in the perinatal period (at birth up to day of life 21), since they may be elevated at different points in the disease process. Blood samples (whole blood spots, dried on filter paper) were obtained on day 1 within 4 hours after birth, and on days 3, 7, 14, and 21. Neurodevelopmental assessments were conducted at 18-22 months corrected age.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1067

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249-7335
        • University of Alabama
    • California
      • Palo Alto, California, United States, 94304
        • Stanford University
      • San Diego, California, United States, 92103-8774
        • University of California at San Diego
    • Connecticut
      • New Haven, Connecticut, United States, 06504
        • Yale University
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Emory University
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State University
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico
    • North Carolina
      • Charlotte, North Carolina, United States, 27157
        • Wake Forest University
      • Durham, North Carolina, United States, 27710
        • Duke University
      • Durham, North Carolina, United States, 27705
        • RTI International
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Cincinnati Children's Medical Center
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University, Rainbow Babies and Children's Hospital
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Brown University, Women & Infants Hospital of Rhode Island
    • Tennessee
      • Memphis, Tennessee, United States, 38163
        • University of Tennessee
    • Texas
      • Dallas, Texas, United States, 75235
        • University Of Texas Southwestern Medical Center At Dallas
      • Houston, Texas, United States, 77030
        • University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 3 days (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Infants 401-1,000 grams at birth of both genders and all racial/ethnic groups.

Description

Inclusion Criteria:

  • Infants 401-1,000 grams at birth

Exclusion Criteria:

  • >72 hours of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Pro-cytokines increased and anti-inflammatory cytokines decreased
Time Frame: At birth and/or up to Day 3±1
At birth and/or up to Day 3±1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Type and severity of CP and other neurodevelopmental handicaps, the appearance of PVL, and neonatal mortality
Time Frame: 18-22 months corrected age
18-22 months corrected age
Abnormal pro-inflammatory and anti-inflammatory cytokines at birth are associated with prenatal insults (e.g., chorioamnionitis, occult intrauterine infection, early-onset neonatal sepsis, perinatal asphyxia, early death)
Time Frame: At birth
At birth
Abnormal postnatal cytokine levels associated with postnatal insults (e.g., postnatal intraventricular hemorrhage, late-onset neonatal sepsis, bronchopulmonary dysplasia, chronic lung disease, and/or necrotizing enterocolitis)
Time Frame: Up to Day of life 21
Up to Day of life 21
Pro-inflammatory cytokine elevations at the time of a workup for possible sepsis occur in infants with a positive bacterial blood culture and those with negative blood cultures who are treated with a full course of antibiotics
Time Frame: Up to Day of life 21
Up to Day of life 21

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NICHD Neonatal Research Network

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centers for Disease Control and Prevention
National Center for Research Resources (NCRR)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shahnaz Duara, MD, University of Miami
  • Principal Investigator: Michele C. Walsh, MD MS, Case Western Reserve University, Rainbow Babies & Children's Hospital
  • Principal Investigator: Jon E. Tyson, MD MPH, The University of Texas Health Science Center, Houston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 1999

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2002

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2004

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 17, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 21, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 22, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NICHD-NRN-0022
  • M01RR000633 (U.S. NIH Grant/Contract)
  • U10HD021364 (U.S. NIH Grant/Contract)
  • U10HD021373 (U.S. NIH Grant/Contract)
  • U10HD021385 (U.S. NIH Grant/Contract)
  • U10HD027851 (U.S. NIH Grant/Contract)
  • U10HD027853 (U.S. NIH Grant/Contract)
  • U10HD027856 (U.S. NIH Grant/Contract)
  • U10HD027871 (U.S. NIH Grant/Contract)
  • U10HD027880 (U.S. NIH Grant/Contract)
  • U10HD027904 (U.S. NIH Grant/Contract)
  • U10HD034216 (U.S. NIH Grant/Contract)
  • U10HD040492 (U.S. NIH Grant/Contract)
  • U10HD040689 (U.S. NIH Grant/Contract)
  • U10HD021415 (U.S. NIH Grant/Contract)
  • U10HD027881 (U.S. NIH Grant/Contract)
  • M01RR008084 (U.S. NIH Grant/Contract)
  • M01RR006022 (U.S. NIH Grant/Contract)
  • M01RR000750 (U.S. NIH Grant/Contract)
  • M01RR000070 (U.S. NIH Grant/Contract)
  • M01RR000997 (U.S. NIH Grant/Contract)
  • U10HD021397 (U.S. NIH Grant/Contract)
  • U10HD040461 (U.S. NIH Grant/Contract)
  • U10HD040498 (U.S. NIH Grant/Contract)
  • M01RR000032 (U.S. NIH Grant/Contract)
  • M01RR000039 (U.S. NIH Grant/Contract)
  • M01RR000080 (U.S. NIH Grant/Contract)
  • M01RR007122 (U.S. NIH Grant/Contract)
  • M01RR016587 (U.S. NIH Grant/Contract)
  • M01RR000030 (U.S. NIH Grant/Contract)
  • U01HD036790 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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