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PMID- 28672318
OWN - NLM
STAT- In-Process
DA  - 20170703
LR  - 20170703
IS  - 1538-3598 (Electronic)
IS  - 0098-7484 (Linking)
VI  - 318
IP  - 1
DP  - 2017 Jul 04
TI  - Effect of Depth and Duration of Cooling on Death or Disability at Age 18 Months
      Among Neonates With Hypoxic-Ischemic Encephalopathy: A Randomized Clinical Trial.
PG  - 57-67
LID - 10.1001/jama.2017.7218 [doi]
AB  - Importance: Hypothermia for 72 hours at 33.5 degrees C for neonatal
      hypoxic-ischemic encephalopathy reduces death or disability, but rates continue
      to be high. Objective: To determine if cooling for 120 hours or to a temperature 
      of 32.0 degrees C reduces death or disability at age 18 months in infants with
      hypoxic-ischemic encephalopathy. Design, Setting, and Participants: Randomized 2 
      x 2 factorial clinical trial in neonates (>/=36 weeks' gestation) with
      hypoxic-ischemic encephalopathy at 18 US centers in the Eunice Kennedy Shriver
      National Institute of Child Health and Human Development Neonatal Research
      Network between October 2010 and January 2016. Interventions: A total of 364
      neonates were randomly assigned to 4 hypothermia groups: 33.5 degrees C for 72
      hours (n = 95), 32.0 degrees C for 72 hours (n = 90), 33.5 degrees C for 120
      hours (n = 96), or 32.0 degrees C for 120 hours (n = 83). Main Outcomes and
      Measures: The primary outcome was death or moderate or severe disability at 18 to
      22 months of age adjusted for center and level of encephalopathy. Severe
      disability included any of Bayley Scales of Infant Development III cognitive
      score less than 70, Gross Motor Function Classification System (GMFCS) level of 3
      to 5, or blindness or hearing loss despite amplification. Moderate disability was
      defined as a cognitive score of 70 to 84 and either GMFCS level 2, active
      seizures, or hearing with amplification. Results: The trial was stopped for
      safety and futility in November 2013 after 364 of the planned 726 infants were
      enrolled. Among 347 infants (95%) with primary outcome data (mean age at
      follow-up, 20.7 [SD, 3.5] months; 42% female), death or disability occurred in 56
      of 176 (31.8%) cooled for 72 hours and 54 of 171 (31.6%) cooled for 120 hours
      (adjusted risk ratio, 0.92 [95% CI, 0.68-1.25]; adjusted absolute risk
      difference, -1.0% [95% CI, -10.2% to 8.1%]) and in 59 of 185 (31.9%) cooled to
      33.5 degrees C and 51 of 162 (31.5%) cooled to 32.0 degrees C (adjusted risk
      ratio, 0.92 [95% CI, 0.68-1.26]; adjusted absolute risk difference, -3.1% [95%
      CI, -12.3% to 6.1%]). A significant interaction between longer and deeper cooling
      was observed (P = .048), with primary outcome rates of 29.3% at 33.5 degrees C
      for 72 hours, 34.5% at 32.0 degrees C for 72 hours, 34.4% at 33.5 degrees C for
      120 hours, and 28.2% at 32.0 degrees C for 120 hours. Conclusions and Relevance: 
      Among term neonates with moderate or severe hypoxic-ischemic encephalopathy,
      cooling for longer than 72 hours, cooling to lower than 33.5 degrees C, or both
      did not reduce death or moderate or severe disability at 18 months of age.
      However, the trial may be underpowered, and an interaction was found between
      longer and deeper cooling. These results support the current regimen of cooling
      for 72 hours at 33.5 degrees C. Trial Registration: clinicaltrials.gov
      Identifier: NCT01192776.
FAU - Shankaran, Seetha
AU  - Shankaran S
AD  - Department of Pediatrics, Wayne State University, Detroit, Michigan.
FAU - Laptook, Abbot R
AU  - Laptook AR
AD  - Department of Pediatrics, Women and Infants Hospital, Brown University,
      Providence, Rhode Island.
FAU - Pappas, Athina
AU  - Pappas A
AD  - Department of Pediatrics, Wayne State University, Detroit, Michigan.
FAU - McDonald, Scott A
AU  - McDonald SA
AD  - Social, Statistical and Environmental Sciences Unit, RTI International, Research 
      Triangle Park, North Carolina.
FAU - Das, Abhik
AU  - Das A
AD  - Social, Statistical and Environmental Sciences Unit, RTI International,
      Rockville, Maryland.
FAU - Tyson, Jon E
AU  - Tyson JE
AD  - Department of Pediatrics, McGovern Medical School, the University of Texas Health
      Science Center at Houston.
FAU - Poindexter, Brenda B
AU  - Poindexter BB
AD  - Department of Pediatrics, Indiana University School of Medicine,
      Indianapolis7Perinatal Institute, Cincinnati Children's Hospital Medical Center, 
      Cincinnati, Ohio.
FAU - Schibler, Kurt
AU  - Schibler K
AD  - Perinatal Institute, Cincinnati Children's Hospital Medical Center, Cincinnati,
      Ohio.
FAU - Bell, Edward F
AU  - Bell EF
AD  - Department of Pediatrics, University of Iowa, Iowa City.
FAU - Heyne, Roy J
AU  - Heyne RJ
AD  - Department of Pediatrics, University of Texas Southwestern Medical Center,
      Dallas.
FAU - Pedroza, Claudia
AU  - Pedroza C
AD  - Department of Pediatrics, McGovern Medical School, the University of Texas Health
      Science Center at Houston.
FAU - Bara, Rebecca
AU  - Bara R
AD  - Department of Pediatrics, Wayne State University, Detroit, Michigan.
FAU - Van Meurs, Krisa P
AU  - Van Meurs KP
AD  - Division of Neonatal and Developmental Medicine, Department of Pediatrics,
      Stanford University School of Medicine and Lucile Packard Children's Hospital,
      Palo Alto, California.
FAU - Huitema, Carolyn M Petrie
AU  - Huitema CMP
AD  - Social, Statistical and Environmental Sciences Unit, RTI International,
      Rockville, Maryland.
FAU - Grisby, Cathy
AU  - Grisby C
AD  - Perinatal Institute, Cincinnati Children's Hospital Medical Center, Cincinnati,
      Ohio.
FAU - Devaskar, Uday
AU  - Devaskar U
AD  - Department of Pediatrics, University of California, Los Angeles.
FAU - Ehrenkranz, Richard A
AU  - Ehrenkranz RA
AD  - Department of Pediatrics, Yale University School of Medicine, New Haven,
      Connecticut.
FAU - Harmon, Heidi M
AU  - Harmon HM
AD  - Department of Pediatrics, Indiana University School of Medicine, Indianapolis.
FAU - Chalak, Lina F
AU  - Chalak LF
AD  - Department of Pediatrics, University of Texas Southwestern Medical Center,
      Dallas.
FAU - DeMauro, Sara B
AU  - DeMauro SB
AD  - Department of Pediatrics, Perelman School of Medicine, University of
      Pennsylvania, the Children's Hospital of Philadelphia, Philadelphia,
      Pennsylvania.
FAU - Garg, Meena
AU  - Garg M
AD  - Department of Pediatrics, University of California, Los Angeles.
FAU - Hartley-McAndrew, Michelle E
AU  - Hartley-McAndrew ME
AD  - Department of Pediatrics, University at Buffalo, Buffalo, New York.
FAU - Khan, Amir M
AU  - Khan AM
AD  - Department of Pediatrics, McGovern Medical School, the University of Texas Health
      Science Center at Houston.
FAU - Walsh, Michele C
AU  - Walsh MC
AD  - Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western
      Reserve University, Cleveland, Ohio.
FAU - Ambalavanan, Namasivayam
AU  - Ambalavanan N
AD  - Division of Neonatology, University of Alabama at Birmingham.
FAU - Brumbaugh, Jane E
AU  - Brumbaugh JE
AD  - Department of Pediatrics, University of Iowa, Iowa City.
FAU - Watterberg, Kristi L
AU  - Watterberg KL
AD  - University of New Mexico Health Sciences Center, Albuquerque.
FAU - Shepherd, Edward G
AU  - Shepherd EG
AD  - Department of Pediatrics, Nationwide Children's Hospital-The Ohio State
      University, Columbus.
FAU - Hamrick, Shannon E G
AU  - Hamrick SEG
AD  - Department of Pediatrics, Emory University School of Medicine, Children's
      Healthcare of Atlanta, Atlanta, Georgia.
FAU - Barks, John
AU  - Barks J
AD  - Department of Pediatrics, University of Michigan, Ann Arbor.
FAU - Cotten, C Michael
AU  - Cotten CM
AD  - Department of Pediatrics, Duke University, Durham, North Carolina.
FAU - Kilbride, Howard W
AU  - Kilbride HW
AD  - Department of Pediatrics, Children's Mercy Hospital and University of Missouri
      Kansas City School of Medicine, Kansas City.
FAU - Higgins, Rosemary D
AU  - Higgins RD
AD  - Eunice Kennedy Shriver National Institute of Child Health and Human Development, 
      National Institutes of Health, Bethesda, Maryland.
CN  - Eunice Kennedy Shriver National Institute of Child Health and Human Development
      Neonatal Research Network
LA  - eng
PT  - Journal Article
PL  - United States
TA  - JAMA
JT  - JAMA
JID - 7501160
EDAT- 2017/07/04 06:00
MHDA- 2017/07/04 06:00
CRDT- 2017/07/04 06:00
AID - 2635631 [pii]
AID - 10.1001/jama.2017.7218 [doi]
PST - ppublish
SO  - JAMA. 2017 Jul 4;318(1):57-67. doi: 10.1001/jama.2017.7218.