Inflammatory Cytokines Associated With Perinatal Brain Injury

NCT01035697 | Completed

• 31 other identifiers: NICHD-NRN-0022U10HD027853M01RR008084U10HD040492M01RR000030U10HD027851M01RR000039U10HD027856M01RR000750U10HD021364M01RR000080U01HD036790U10HD027880M01RR000070U10HD034216M01RR000032U10HD040461U10HD021397M01RR016587U10HD027881M01RR000997U10HD021415U10HD040689M01RR000633U10HD021373U10HD040498M01RR007122U10HD021385U10HD027904U10HD027871M01RR006022
• Study Type: observational
• Target: 1,067
• Locations: 1 country
• Sites: 18

Brief Summary

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.

Conditions

Infant, Newborn; Infant, Low Birth Weight; Infant, Small for Gestational Age; Infant, Premature; Cerebral Palsy

Keywords

NICHD Neonatal Research Network; Very Low Birth Weight (VLBW); Extremely Low Birth Weight (ELBW); Prematurity; Pro-inflammatory cytokines; Anti-inflammatory cytokines; Interleukin-1 (IL-1β); Interleukin-2 (IL-2); Interleukin-3 (IL-3); Interleukin-8 (IL-8); Interleukin-9 (IL-9); Tumor necrosis factor-α (TNF-α); Regulated upon Activation, Normal T-cell Expressed and Secreted (RANTES)

Outcome Measures

Primary Outcomes (1)

• Pro-cytokines increased and anti-inflammatory cytokines decreased

  At birth and/or up to Day 3±1

Secondary Outcomes (4)

• Type and severity of CP and other neurodevelopmental handicaps, the appearance of PVL, and neonatal mortality

  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)

  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)

  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

  Up to Day of life 21

Eligibility Criteria

• Age: Up to 72 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Infants 401-1,000 grams at birth

You may not qualify if:

• \>72 hours of age

Sponsors & Collaborators

• NICHD Neonatal Research Network: lead
• Centers for Disease Control and Prevention: collaborator
• National Center for Research Resources (NCRR): collaborator

Study Sites (18)

University of Alabama

Birmingham, Alabama, 35249-7335, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

University of California at San Diego

San Diego, California, 92103-8774, United States

Location

Yale University

New Haven, Connecticut, 06504, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Emory University

Atlanta, Georgia, 30303, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Wake Forest University

Charlotte, North Carolina, 27157, United States

Location

RTI International

Durham, North Carolina, 27705, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Cincinnati Children's Medical Center

Cincinnati, Ohio, 45267, United States

Location

Case Western Reserve University, Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106, United States

Location

Brown University, Women & Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

Location

University of Tennessee

Memphis, Tennessee, 38163, United States

Location

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75235, United States

Location

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (4)

• Ambalavanan N, Carlo WA, D'Angio CT, McDonald SA, Das A, Schendel D, Thorsen P, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Cytokines associated with bronchopulmonary dysplasia or death in extremely low birth weight infants. Pediatrics. 2009 Apr;123(4):1132-41. doi: 10.1542/peds.2008-0526.

  PMID: 19336372 RESULT

• Natarajan G, Shankaran S, McDonald SA, DAS A, Stoll BJ, Higgins RD, Thorsen P, Skogstrand K, Hougaard DM, Carlo WA; NICHD neonatal research network. Circulating beta chemokine and MMP 9 as markers of oxidative injury in extremely low birth weight infants. Pediatr Res. 2010 Jan;67(1):77-82. doi: 10.1203/PDR.0b013e3181c0b16c.

  PMID: 19755933 RESULT

• Sood BG, Madan A, Saha S, Schendel D, Thorsen P, Skogstrand K, Hougaard D, Shankaran S, Carlo W; NICHD neonatal research network. Perinatal systemic inflammatory response syndrome and retinopathy of prematurity. Pediatr Res. 2010 Apr;67(4):394-400. doi: 10.1203/PDR.0b013e3181d01a36.

  PMID: 20032809 RESULT

• Carlo WA, McDonald SA, Tyson JE, Stoll BJ, Ehrenkranz RA, Shankaran S, Goldberg RN, Das A, Schendel D, Thorsen P, Skogstrand K, Hougaard DM, Oh W, Laptook AR, Duara S, Fanaroff AA, Donovan EF, Korones SB, Stevenson DK, Papile LA, Finer NN, O'Shea TM, Poindexter BB, Wright LL, Ambalavanan N, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Cytokines and neurodevelopmental outcomes in extremely low birth weight infants. J Pediatr. 2011 Dec;159(6):919-25.e3. doi: 10.1016/j.jpeds.2011.05.042. Epub 2011 Jul 27.

  PMID: 21798559 RESULT

Related Links

• NICHD Neonatal Research Network

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood spots collected on filter paper.

MeSH Terms

Conditions

Premature Birth; Cerebral Palsy

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• William Oh, MD

  Brown University, Women & Infants Hospital of Rhode Island

  PRINCIPAL INVESTIGATOR

• Michele C. Walsh, MD MS

  Case Western Reserve University, Rainbow Babies & Children's Hospital

  PRINCIPAL INVESTIGATOR

• Ronald N. Goldberg, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Barbara J. Stoll, MD

  Emory University

  PRINCIPAL INVESTIGATOR

• James A. Lemons, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

• Abhik Das, PhD

  RTI International

  PRINCIPAL INVESTIGATOR

• David K. Stevenson, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Waldemar A. Carlo, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• Neil N. Finer, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

• Edward F. Donovan, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

• Shahnaz Duara, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

• Lu-Ann Papile, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

• Sheldon B. Korones, MD

  University of Tennessee

  PRINCIPAL INVESTIGATOR

• Jon E. Tyson, MD MPH

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

• Abbot R. Laptook, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

• T. Michael O'Shea, MD MPH

  Wake Forest University

  PRINCIPAL INVESTIGATOR

• Seetha Shankaran, MD

  Wayne State University

  PRINCIPAL INVESTIGATOR

• Richard A. Ehrenkranz, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: December 17, 2009
• First Posted: December 21, 2009
• Study Start: July 1, 1999
• Primary Completion: July 1, 2002
• Study Completion: May 1, 2004
• Last Updated: March 22, 2019

Record last verified: 2019-03

Locations

US (18)