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Late Hypothermia for Hypoxic-Ischemic Encephalopathy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00614744
First Posted: February 13, 2008
Last Update Posted: August 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Center for Research Resources (NCRR)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
NICHD Neonatal Research Network
Results First Submitted: June 30, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Infant, Newborn
Hypoxia, Brain
Hypoxia-Ischemia, Brain
Encephalopathy, Hypoxic-Ischemic
Hypoxic-Ischemic Encephalopathy
Ischemic-Hypoxic Encephalopathy
Interventions: Procedure: Hypothermia
Procedure: Normothermic Control

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Multicenter randomized trial to evaluate whether induced hypothermia with body cooling initiated between 6-24 hours of age and continued for 96 hours in infants >= 36 weeks gestation with hypoxic-ischemic encephalopathy will reduce the incidence of death or disability at 18 months of age. Eligible infants were enrolled from 05/06/08 to 07/12/14.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Whole-body Hypothermia Induced Whole-body hypothermia (with a target esophageal temperature of 33.5°C) for 96 hours
Normothermia Normothermic Control group (with esophageal temperature at or near 37.0°C) for 96 hours

Participant Flow:   Overall Study
    Whole-body Hypothermia   Normothermia
STARTED   83   85 
COMPLETED   78   79 
NOT COMPLETED   5   6 
Lost to Follow-up                5                4 
Incomplete for Behavior Issues                0                2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Whole-body Hypothermia Induced Whole-body hypothermia (with a target esophageal temperature of 33.5°C) for 96 hours
Normothermia Normothermic Control group (with esophageal temperature at or near 37.0°C) for 96 hours
Total Total of all reporting groups

Baseline Measures
   Whole-body Hypothermia   Normothermia   Total 
Overall Participants Analyzed 
[Units: Participants]
 83   85   168 
Age, Customized [1] 
[Units: Participants]
Count of Participants
     
<= 12 Hours   26   28   54 
> 12 Hours   57   57   114 
[1] Age at Randomization
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      47  56.6%      55  64.7%      102  60.7% 
Male      36  43.4%      30  35.3%      66  39.3% 
Level of Encephalopathy 
[Units: Participants]
Count of Participants
     
Moderate   73   78   151 
Severe   10   7   17 
Birthweight 
[Units: Grams]
Mean (Standard Deviation)
 3379  (528)   3303  (553)   3340  (541) 
Length 
[Units: Centimeters]
Mean (Standard Deviation)
 51  (3)   51  (3)   51  (3) 
Gestational Age 
[Units: Weeks]
Mean (Standard Deviation)
 39  (2)   39  (1)   39  (1) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Death or Moderate or Severe Disability   [ Time Frame: Birth to 18-22 months corrected gestational age ]

2.  Secondary:   Number of Deaths in the NICU and Following Discharge   [ Time Frame: Birth to 18-22 months corrected gestational age ]

3.  Secondary:   Number of Infants With Moderate and Severe Disability   [ Time Frame: Birth to 18-22 months corrected gestational age ]

4.  Secondary:   Number of Infants With Mild, Moderate and Severe Disability   [ Time Frame: Birth to 18-22 months corrected gestational age ]

5.  Secondary:   Number of Infants With Any Disability Based on Level of Encephalopathy at Randomization   [ Time Frame: Birth to 18-22 months corrected gestational age ]

6.  Secondary:   Number of Infants With Non-CNS Organ System Dysfunction   [ Time Frame: Birth to 18-22 months corrected gestational age ]

7.  Secondary:   Number of Infants With a DNR Order   [ Time Frame: Birth to 18-22 months corrected gestational age ]

8.  Secondary:   Number of Infants With a DNR Order and Support is Withdrawn   [ Time Frame: Birth to 18-22 months corrected gestational age ]

9.  Secondary:   Number of Infants With a DNR Order That Died   [ Time Frame: Birth to 18-22 months corrected gestational age ]

10.  Secondary:   Number of Infants With Neonatal Seizures, With and Without EEG Abnormalities   [ Time Frame: Birth to 18-22 months corrected gestational age ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Abbot Laptook
Organization: Brown University, Women & Infants Hospital of Rhode Island
phone: 401-274-1122 ext 47421
e-mail: alaptook@wihri.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: NICHD Neonatal Research Network
ClinicalTrials.gov Identifier: NCT00614744     History of Changes
Other Study ID Numbers: NICHD-NRN-0038
U10HD036790 ( 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 )
U10HD053089 ( U.S. NIH Grant/Contract )
U10HD053109 ( U.S. NIH Grant/Contract )
U10HD053119 ( U.S. NIH Grant/Contract )
U10HD053124 ( U.S. NIH Grant/Contract )
UL1RR024139 ( U.S. NIH Grant/Contract )
UL1RR025744 ( U.S. NIH Grant/Contract )
UL1RR024979 ( U.S. NIH Grant/Contract )
U10HD068244 ( U.S. NIH Grant/Contract )
1U10HD068263-01 ( U.S. NIH Grant/Contract )
U10HD068270 ( U.S. NIH Grant/Contract )
U10HD068278 ( U.S. NIH Grant/Contract )
U10HD068284 ( U.S. NIH Grant/Contract )
First Submitted: February 11, 2008
First Posted: February 13, 2008
Results First Submitted: June 30, 2017
Results First Posted: August 7, 2017
Last Update Posted: August 7, 2017