Preemie Hypothermia for Neonatal Encephalopathy



Status:Recruiting
Conditions:Peripheral Vascular Disease, Infectious Disease, Hospital, Neurology, Psychiatric
Therapuetic Areas:Cardiology / Vascular Diseases, Immunology / Infectious Diseases, Neurology, Psychiatry / Psychology, Other
Healthy:No
Age Range:Any
Updated:3/13/2019
Start Date:May 2015
End Date:October 2022
Contact:Roger G Faix, MD
Phone:801-581-7052

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A Randomized Trial of Targeted Temperature Management With Whole Body Hypothermia For Moderate And Severe Hypoxic-Ischemic Encephalopathy In Premature Infants 33-35 Weeks Gestational Age.

This study is a randomized, controlled trial to assess safety and effectiveness of whole body
hypothermia for 72 hours in preterm infants 33-35 weeks gestational age (GA) who present at
<6 hours postnatal age with moderate to severe neonatal encephalopathy (NE). The study will
enroll infants with signs of NE at 18 NICHD Neonatal Research Network sites, and randomly
assign them to either receive hypothermia or participate in a non-cooled control group.

Most clinical studies of neonatal encephalopathy (NE) and potential interventions have
focused on infants ≥36 weeks GA. Although many interventions have been suggested and assessed
for prevention or palliation of NE, the only one currently supported by rigorous clinical
evidence to improve outcome in human newborns has been hypothermia implemented at <6 hours of
postnatal age and maintained for 72 hrs. Data about diagnosis, frequency, severity, and
outcome of NE in infants 33-35 weeks GA are sparse.

This trial will assess safety and effectiveness of whole body hypothermia for 72 hours in
preterm infants 33-35 weeks gestational age (GA) who present at <6 hrs postnatal age with
moderate to severe neonatal encephalopathy. Infants 33 0/7 to 35 6/7 weeks GA (best
obstetrical estimate) and greater than or equal to 1500 grams birth weight (selected to
minimize potential difficulties placing esophageal probe) who meet clinical, biochemical and
neurologic criteria for moderate to severe NE will be randomized to either whole body
hypothermia or participate in a non-cooled control group. The primary outcome will be death
or moderate to severe disability at 18-22 months corrected age. The presence or absence of
disability will be determined by the standard NRN interdisciplinary follow-up exam.

Secondary Study includes determining an association between MRI detectable injury and
neurodevelopment at 18-22 months.

Inclusion Criteria:

- Infants 33 0/7 to 35 6/7 weeks GA (best obstetrical estimate)

- Infants weight greater than or equal to 1500 grams at birth

- Postnatal age less than 6 hours

- Infants who meet clinical, biochemical and neurologic criteria for moderate to severe
NE:

Biochemical: Cord gas or blood gas within first hour of life with pH ≤7.00 or base deficit
(BD) ≥16 mEq/L OR

Acute perinatal event (e.g., abruptio placenta, cord prolapse, uterine rupture, severe FHR
abnormality such as variable or late decelerations) AND Requirement for positive pressure
ventilation for apnea or poor respiratory effort since birth for at least 10 minutes OR 10
minute Apgar score ≤5

AND

Neurologic:

Seizures OR modified Sarnat score with abnormalities in at least 3 of the 6 categories; at
least one must be altered level of consciousness (lethargy or stupor/coma) as determined by
a certified examiner (All infants who meet criteria for potential inclusion will undergo
standard neurologic exam as for infants ≥36 wks GA being considered for hypothermia, with
findings recorded)

Exclusion Criteria:

- Receipt of sedative, analgesic or paralytic agent that may confound the qualifying
neurologic exam

- Etiology of NE not likely to be hypoxic-ischemic in origin

- Major congenital anomaly that may confound outcome

- Considered to be moribund and will not be receiving full intensive care

- Equipment and/or appropriate staff not available

- Core temperature < 33.5oC for more than one hour at time of screening

- Unable to randomize by 6 hours of age

- Infant needs ECMO

- All blood gases (cord and postnatal at < 1hr of age) have a pH > 7.15 AND a base
deficit < 10mEq/L
We found this trial at
18
sites
5050 Anthony Wayne Dr
Detroit, Michigan 48201
(313) 577-2424
Principal Investigator: Seetha Shankaran, MD
Phone: 313-745-1436
Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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Detroit, MI
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: David P Carlton, MD
Phone: 404-727-2456
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Waldemar A. Carlo, MD
Phone: 205-934-4680
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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5323 Harry Hines Blvd
Dallas, Texas 75235
(214) 648-3111
Principal Investigator: Myra Wyckoff, MD
Phone: 214-648-3923
Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
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3040 East Cornwallis RoadTriangle
Durham, North Carolina 27705
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Durham, NC
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Durham, North Carolina 27710
(919) 684-8111
Phone: 919-681-6024
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Durham, NC
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
Principal Investigator: Jon E. Tyson, MD MPH
Phone: 713-500-6708
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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Houston, TX
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Principal Investigator: Brenda B. Poindexter, MD MS
Phone: 317-274-4768
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Indianapolis, IN
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
Principal Investigator: Edward F. Bell, MD
Phone: 319-356-4006
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Iowa City, IA
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Providence, Rhode Island 02905
Principal Investigator: Abbot R. Laptook, MD
Phone: 401-274-1122
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Providence, RI
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
Principal Investigator: Carl T D'Angio, MD
Phone: 585-273-4911
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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Rochester, NY
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Bradley A. Yoder, MD
University of Utah Research is a major component in the life of the U benefiting...
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Albuquerque, New Mexico 87131
(505) 277-0111
Principal Investigator: Kristi L. Watterberg, MD
Phone: 505-272-8609
University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
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Albuquerque, NM
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Cincinnati, Ohio 45267
Principal Investigator: Brenda Poindexter, MD
Phone: 513-636-3972
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Cleveland, Ohio 44106
Principal Investigator: Michele C. Walsh, MD MS
Phone: 216-844-3387
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Cleveland, OH
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Columbus, Ohio 43205
Principal Investigator: Pablo Sanchez, MD
Phone: 614-355-6724
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Columbus, OH
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Palo Alto, California 94304
Principal Investigator: Krisa P. Van Meurs, MD
Phone: 650-723-5711
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Philadelphia, Pennsylvania 19104
Principal Investigator: Eric Eichenwald, MD
Phone: 215-662-3228
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Philadelphia, PA
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