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Optimizing (Longer, Deeper) Cooling for Neonatal Hypoxic-Ischemic Encephalopathy(HIE)

This study has been terminated.
(The trial closed for emerging safety profile and futility analysis and will not resume.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01192776
First Posted: September 1, 2010
Last Update Posted: October 3, 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: March 31, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial 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
Intervention: Procedure: Whole-body Cooling

  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
1261 infants assessed for eligibility. 897 were excluded for not meeting eligibility criteria (N=747) or not having parental or physician consent (N=150).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All eligible infants with consent were randomized to one of four treatment arms/groups.

Reporting Groups
  Description
33.5°C for 72 Hours

Target Temp: 33.5°C Duration: 72 hrs

Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours.

32.0°C for 72 Hours

Target Temp: 32.0°C Duration: 72 hrs

Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours.

33.5°C for 120 Hours

Target Temp: 33.5°C Duration: 120 hrs

Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours.

32.0°C for 120 Hours

Target Temp: 32.0°C Duration:120 hrs

Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours.


Participant Flow:   Overall Study
    33.5°C for 72 Hours   32.0°C for 72 Hours   33.5°C for 120 Hours   32.0°C for 120 Hours
STARTED   95   90   96   83 
Died Prior to Discharge   7   13   15   14 
Died After Discharge   1   2   3   1 
COMPLETED   84   69   75   63 
NOT COMPLETED   11   21   21   20 
Death                8                15                18                15 
Lost to Follow-up                3                6                3                5 



  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
33.5°C for 72 Hours

Target Temp: 33.5°C Duration: 72 hrs

Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours.

32.0°C for 72 Hours

Target Temp: 32.0°C Duration: 72 hrs

Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours.

33.5°C for 120 Hours

Target Temp: 33.5°C Duration: 120 hrs

Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours.

32.0°C for 120 Hours

Target Temp: 32.0°C Duration:120 hrs

Whole-body Cooling: Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours.

Total Total of all reporting groups

Baseline Measures
   33.5°C for 72 Hours   32.0°C for 72 Hours   33.5°C for 120 Hours   32.0°C for 120 Hours   Total 
Overall Participants Analyzed 
[Units: Participants]
 95   90   96   83   364 
Age [1] [2] 
[Units: Hours]
Mean (Standard Deviation)
         
Participants Analyzed 
[Units: Participants]
 95   90   95   83   363 
   5.1  (1.0)   4.9  (1.2)   4.8  (1.1)   5.0  (1.6)   4.9  (1.2) 
[1] Age at Randomization
[2] Data was missing for one participant.
Sex/Gender, Customized 
[Units: Participants]
Count of Participants
         
Male           
Participants Analyzed 
[Units: Participants]
 95   90   96   83   364 
Male   52   53   51   56   212 
Female           
Participants Analyzed 
[Units: Participants]
 95   90   96   83   364 
Female   43   37   44   27   151 
Ambiguous           
Participants Analyzed 
[Units: Participants]
 95   90   96   83   364 
Ambiguous   0   0   1   0   1 
Race/Ethnicity, Customized [1] 
[Units: Participants]
Count of Participants
         
Black           
Participants Analyzed 
[Units: Participants]
 95   89   94   80   358 
Black   29   28   32   25   114 
White           
Participants Analyzed 
[Units: Participants]
 95   89   94   80   358 
White   60   56   55   48   219 
Other           
Participants Analyzed 
[Units: Participants]
 95   89   94   80   358 
Other   6   5   7   7   25 
[1] Data was missing for six participants.
Birthweight [1] 
[Units: Grams]
Mean (Standard Deviation)
         
Participants Analyzed 
[Units: Participants]
 95   90   95   83   363 
   3230  (528)   3360  (544)   3354  (676)   3511  (615)   3359  (599) 
[1] Data was missing for one participant.
Level of encephalopathy 
[Units: Participants]
Count of Participants
         
Participants Analyzed 
[Units: Participants]
 95   90   96   83   364 
Moderate      74  77.9%      70  77.8%      78  81.3%      58  69.9%      280  76.9% 
Severe      21  22.1%      20  22.2%      18  18.8%      25  30.1%      84  23.1% 


  Outcome Measures
  Show All Outcome Measures

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

2.  Secondary:   Death   [ Time Frame: Birth to 22 months corrected age ]

3.  Secondary:   Level of Disability Among Survivors   [ Time Frame: Follow up at 18-22 months corrected age ]

4.  Secondary:   Withdrawal of Care   [ Time Frame: Birth through hospital discharge, average 22 days. ]

5.  Secondary:   Clinical Neonatal Seizures   [ Time Frame: Through death, discharge, or transfer ]

6.  Secondary:   Bayley Cognitive Score   [ Time Frame: Follow up at 18-22 months corrected age ]

7.  Secondary:   Cerebral Palsy   [ Time Frame: Follow up at 18-22 months corrected age ]

8.  Secondary:   Level of Disability Among Survivors, by Level of HIE   [ Time Frame: Follow up at 18-22 months corrected age ]

9.  Secondary:   Visual Impairment   [ Time Frame: Follow up at 18-22 months corrected age ]

10.  Secondary:   Hearing Impairment   [ Time Frame: Follow up at 18-22 months corrected age ]

11.  Secondary:   Multiple Disabilities   [ Time Frame: Follow up at 18-22 months corrected age ]

12.  Secondary:   Multiorgan Dysfunction   [ Time Frame: Until death, discharge, or transfer ]
Results not yet reported.   Anticipated Reporting Date:   03/2018  

13.  Other Pre-specified:   Severe Neonatal Brain Abnormalities   [ Time Frame: 7-14 days of life ]
Results not yet reported.   Anticipated Reporting Date:   07/2020  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
This RCT was stopped for safety and futility reasons by the Data Safety and Monitoring Committee so did not enroll the target number of participants needed to achieve target power and statistically reliable results.


  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: Seetha Shankaran
Organization: Wayne State University
phone: (313) 745-1436
e-mail: sshankar@med.wayne.edu


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

Responsible Party: NICHD Neonatal Research Network
ClinicalTrials.gov Identifier: NCT01192776     History of Changes
Other Study ID Numbers: NICHD-NRN-0043
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 )
U10HD036790 ( 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 )
UL1RR024979 ( U.S. NIH Grant/Contract )
UL1RR025008 ( U.S. NIH Grant/Contract )
UL1RR025744 ( U.S. NIH Grant/Contract )
UL1RR025747 ( U.S. NIH Grant/Contract )
UL1RR025761 ( U.S. NIH Grant/Contract )
UL1RR025764 ( U.S. NIH Grant/Contract )
U10HD068284 ( U.S. NIH Grant/Contract )
U10HD068278 ( U.S. NIH Grant/Contract )
U10HD068270 ( U.S. NIH Grant/Contract )
U10HD068263 ( U.S. NIH Grant/Contract )
U10HD068244 ( U.S. NIH Grant/Contract )
First Submitted: August 31, 2010
First Posted: September 1, 2010
Results First Submitted: March 31, 2017
Results First Posted: August 15, 2017
Last Update Posted: October 3, 2017