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Moderate Hypothermia in Neonatal Hypoxic Ischemic Encephalopathy

Primary Purpose

Neonatal Asphyxial Encephalopathy, Hypoxic Ischemic Encephalopathy

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
hypothermia
normothermia
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neonatal Asphyxial Encephalopathy focused on measuring hypothermia treatment

Eligibility Criteria

35 Weeks - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

One clinical indication of hypoxic-ischemic injury

  • cord gas pH ≤ 7.0 or base deficit ≥13,
  • initial infant gas pH < 7.1,
  • Apgar score ≤5 at 10 minutes,
  • continued resuscitation after 5 min,
  • fetal bradycardia with heart rate < 80 beats per minute lasting ≥15 min,
  • postnatal event O2 sat <70% or arterial O2<35 for 20 min with ischemia

And two neurologic findings of neonatal encephalopathy, abnormalities of:

  • tone,
  • reflexes,
  • state of consciousness,
  • seizures,
  • posturing,
  • autonomic dysfunction

Exclusion Criteria:

  • Maternal chorioamnionitis,
  • sepsis at birth,
  • birth weight or head circumference <10%,
  • presumed chromosomal abnormality

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Hypothermia

    Normothermia

    Arm Description

    If randomized to hypothermia, plastic bags filled with ice wrapped in a washcloth were applied to the head and body for approximately 2 hours, then the infant was placed on an adult-size, water-circulating, cooling blanket (Cincinnati Sub-Zero Blanketrol II®, Cincinnati, OH), servo-controlled to rectal temperature to 33 ± 0.5 °C for 48 hours at the participating tertiary care center. Rewarming by 0.5°C per hour was begun after 48 hours of hypothermia.

    If randomized to normothermia, rectal temperatures were maintained at 37 ± 0.5 °C per standard neonatal intensive care unit practice, using adult-size, water-circulating, cooling blanket (Cincinnati Sub-Zero Blanketrol II®, Cincinnati, OH), servo-controlled to rectal temperature of 37 ± 0.5 if baby was febrile.

    Outcomes

    Primary Outcome Measures

    Death or severely abnormal Psychomotor Development Index scores on Bayley II
    Death or severe outcomes

    Secondary Outcome Measures

    bradycardia
    number of patients with heart rate < 80 bpm

    Full Information

    First Posted
    May 23, 2016
    Last Updated
    July 5, 2016
    Sponsor
    Medical University of South Carolina
    Collaborators
    National Institute of Neurological Disorders and Stroke (NINDS)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02826941
    Brief Title
    Moderate Hypothermia in Neonatal Hypoxic Ischemic Encephalopathy
    Official Title
    Moderate Hypothermia in Neonatal Hypoxic Ischemic Encephalopathy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1999 (undefined)
    Primary Completion Date
    June 2004 (Actual)
    Study Completion Date
    June 2004 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Medical University of South Carolina
    Collaborators
    National Institute of Neurological Disorders and Stroke (NINDS)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study was a multicenter, randomized, controlled pilot trial of moderate systemic hypothermia (33°C) vs normothermia (37°C) for 48 hours in infants with neonatal encephalopathy instituted within 6 hours of birth or hypoxic-ischemic event.
    Detailed Description
    The trial tested the ability to initiate systemic hypothermia in outlying hospitals and participating tertiary care centers, and determined the incidence of adverse neurologic outcomes of death and developmental scores at 12 months by Bayley II or Vineland tests between normothermic and hypothermic groups. This trial identified potential safety outcomes, compared the adverse effects of hypothermia among hypoxic-ischemic encephalopathy (HIE) infants in the normothermic and hypothermic treatment groups, and obtained rates of adverse outcomes.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neonatal Asphyxial Encephalopathy, Hypoxic Ischemic Encephalopathy
    Keywords
    hypothermia treatment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    65 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Hypothermia
    Arm Type
    Experimental
    Arm Description
    If randomized to hypothermia, plastic bags filled with ice wrapped in a washcloth were applied to the head and body for approximately 2 hours, then the infant was placed on an adult-size, water-circulating, cooling blanket (Cincinnati Sub-Zero Blanketrol II®, Cincinnati, OH), servo-controlled to rectal temperature to 33 ± 0.5 °C for 48 hours at the participating tertiary care center. Rewarming by 0.5°C per hour was begun after 48 hours of hypothermia.
    Arm Title
    Normothermia
    Arm Type
    Placebo Comparator
    Arm Description
    If randomized to normothermia, rectal temperatures were maintained at 37 ± 0.5 °C per standard neonatal intensive care unit practice, using adult-size, water-circulating, cooling blanket (Cincinnati Sub-Zero Blanketrol II®, Cincinnati, OH), servo-controlled to rectal temperature of 37 ± 0.5 if baby was febrile.
    Intervention Type
    Other
    Intervention Name(s)
    hypothermia
    Other Intervention Name(s)
    whole body cooling
    Intervention Description
    Systemic hypothermia by Cincinnati Sub-Zero Blanketrol II®, servo-controlled to 33.0 degrees C rectal temperature, started within 6hours of hypoxic ischemic birth, and continued for 48hours
    Intervention Type
    Other
    Intervention Name(s)
    normothermia
    Intervention Description
    Rectal temperatures in neonates receiving normothermia were maintained at 37.0+or -0.5 degrees C, using overhead warmer or Cincinnati Sub-Zero Blanketrol II®, servo-controlled to rectal temperature of 37.0 degrees C.
    Primary Outcome Measure Information:
    Title
    Death or severely abnormal Psychomotor Development Index scores on Bayley II
    Description
    Death or severe outcomes
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    bradycardia
    Description
    number of patients with heart rate < 80 bpm
    Time Frame
    0-96 hours
    Other Pre-specified Outcome Measures:
    Title
    coagulopathy
    Description
    Mean Prothrombin time
    Time Frame
    1-4 days of life
    Title
    Death
    Description
    numbers of patients who are withdrawn from support or die from multiorgan system failure
    Time Frame
    by 12 months of age

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Weeks
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: One clinical indication of hypoxic-ischemic injury cord gas pH ≤ 7.0 or base deficit ≥13, initial infant gas pH < 7.1, Apgar score ≤5 at 10 minutes, continued resuscitation after 5 min, fetal bradycardia with heart rate < 80 beats per minute lasting ≥15 min, postnatal event O2 sat <70% or arterial O2<35 for 20 min with ischemia And two neurologic findings of neonatal encephalopathy, abnormalities of: tone, reflexes, state of consciousness, seizures, posturing, autonomic dysfunction Exclusion Criteria: Maternal chorioamnionitis, sepsis at birth, birth weight or head circumference <10%, presumed chromosomal abnormality
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dorothea D Jenkins, MD
    Organizational Affiliation
    Medical University of South Carolina
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    upon request
    Citations:
    PubMed Identifier
    15607598
    Citation
    Eicher DJ, Wagner CL, Katikaneni LP, Hulsey TC, Bass WT, Kaufman DA, Horgan MJ, Languani S, Bhatia JJ, Givelichian LM, Sankaran K, Yager JY. Moderate hypothermia in neonatal encephalopathy: efficacy outcomes. Pediatr Neurol. 2005 Jan;32(1):11-7. doi: 10.1016/j.pediatrneurol.2004.06.014.
    Results Reference
    result
    PubMed Identifier
    15607599
    Citation
    Eicher DJ, Wagner CL, Katikaneni LP, Hulsey TC, Bass WT, Kaufman DA, Horgan MJ, Languani S, Bhatia JJ, Givelichian LM, Sankaran K, Yager JY. Moderate hypothermia in neonatal encephalopathy: safety outcomes. Pediatr Neurol. 2005 Jan;32(1):18-24. doi: 10.1016/j.pediatrneurol.2004.06.015.
    Results Reference
    result
    PubMed Identifier
    23897243
    Citation
    Jenkins DD, Lee T, Chiuzan C, Perkel JK, Rollins LG, Wagner CL, Katikaneni LP, Bass WT, Kaufman DA, Horgan MJ, Laungani S, Givelichian LM, Sankaran K, Yager JY, Martin R. Altered circulating leukocytes and their chemokines in a clinical trial of therapeutic hypothermia for neonatal hypoxic ischemic encephalopathy*. Pediatr Crit Care Med. 2013 Oct;14(8):786-95. doi: 10.1097/PCC.0b013e3182975cc9.
    Results Reference
    result
    PubMed Identifier
    22805873
    Citation
    Jenkins DD, Rollins LG, Perkel JK, Wagner CL, Katikaneni LP, Bass WT, Kaufman DA, Horgan MJ, Languani S, Givelichian L, Sankaran K, Yager JY, Martin RH. Serum cytokines in a clinical trial of hypothermia for neonatal hypoxic-ischemic encephalopathy. J Cereb Blood Flow Metab. 2012 Oct;32(10):1888-96. doi: 10.1038/jcbfm.2012.83. Epub 2012 Jul 18.
    Results Reference
    result

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    Moderate Hypothermia in Neonatal Hypoxic Ischemic Encephalopathy

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