California Transport Cooling Trial (CTCT)

This study has been completed.
Sponsor:
Collaborator:
Inspiration Healthcare LTD UK
Information provided by (Responsible Party):
Krisa P Van Meurs, Stanford University
ClinicalTrials.gov Identifier:
NCT01683383
First received: September 6, 2012
Last updated: December 1, 2014
Last verified: December 2014
Results First Received: November 21, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hypoxic Ischemic Encephalopathy
Interventions: Device: Device (servo-regulated cooling)
Other: Control (standard practice)

  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
131 infants were screened for eligibility at nine participating NICUs between October 1, 2012 and September 27th, 2013. Eligible infants had a gestational age of at least 35 weeks, met institutional criteria for use of therapeutic hypothermia, and a decision had been made to initiate cooling in transport.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Infants were excluded if they had a lethal congenital or chromosomal anomaly, the decision had been made to not provide full intensive care, or there was refusal of consent. Of 131 infants screened for eligibility, 30 were excluded, and 101 consented and were randomized.

Reporting Groups
  Description
Control (Standard Cooling) Infants were cooled as per the birth hospital practice either passively (turning the radiant warmer /incubator off) and/or actively (ice or gel packs).
Device (Servo-regulated Cooling) Infants were placed on a servo-controlled cooling blanket after a rectal or esophageal probe was inserted. The temperature was servo-controlled using the Tecotherm Neo (Inspiration Medical LTD, Leicester, UK) (Appendix 1; online only) with the target temperature set to 33.5°C.

Participant Flow:   Overall Study
    Control (Standard Cooling)     Device (Servo-regulated Cooling)  
STARTED     50     51  
Transported and Treated     49     51  
COMPLETED     49     51  
NOT COMPLETED     1     0  
Infant was not transported                 1                 0  



  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.
Eligible newborns

Reporting Groups
  Description
Control (Standard Cooling) Infants were cooled as per the birth hospital practice either passively (turning the radiant warmer /incubator off) and/or actively (ice or gel packs).
Device (Servo-regulated Cooling) Infants were placed on a servo-controlled cooling blanket after a rectal or esophageal probe was inserted. The temperature was servo-controlled using the Tecotherm Neo (Inspiration Medical LTD, Leicester, UK) (Appendix 1; online only) with the target temperature set to 33.5°C.
Total Total of all reporting groups

Baseline Measures
    Control (Standard Cooling)     Device (Servo-regulated Cooling)     Total  
Number of Participants  
[units: participants]
  49     51     100  
Age, Customized [1]
[units: Hours]
Mean (Standard Deviation)
     
Chron. age at cooling initiation at birth hospital     26  (6)     28  (6)     27  (6)  
Gender  
[units: Participants]
     
Female     25     22     47  
Male     24     29     53  
Birth weight  
[units: Grams]
Mean (Standard Deviation)
  3397  (627)     3321  (523)     3358  (610)  
Gestational age  
[units: Weeks]
Mean (Standard Deviation)
  39.1  (1.7)     39.1  (1.7)     39.1  (1.7)  
Apgar scores @ 1 minute [2]
[units: Participants]
     
Apgar @ 1 min ≤ 5     47     42     89  
Apgar @ 1 min > 5     2     9     11  
Apgar scores @ 5 minutes [2]
[units: Participants]
     
Apgar @ 5 min ≤ 5     42     38     80  
Apgar @ 5 min > 5     7     13     20  
Apgar scores @ 10 minutes [2]
[units: Participants]
     
Apgar @ 10 min ≤ 5     27     24     51  
Apgar @ 10 min > 5     22     27     49  
Delivery room resuscitation: Oxygen  
[units: Participants]
     
Oxygen     46     47     93  
No oxygen     3     4     7  
Delivery room resuscitation: CPAP  
[units: Participants]
     
CPAP     18     16     34  
No CPAP     31     35     66  
Delivery room resuscitation: Bag and mask  
[units: Participants]
     
Bag and mask     43     43     86  
No bag and mask     6     8     14  
Delivery room resuscitation: Intubation with ventilation  
[units: Participants]
     
Intubation with ventilation     34     32     66  
No intubation with ventilation     15     19     34  
Delivery room resuscitation: Epinephrine  
[units: Participants]
     
Epinephrine     13     10     23  
No epinephrine     36     41     77  
Delivery room resuscitation: Chest compressions  
[units: Participants]
     
Chest compressions     20     22     42  
No chest compressions     29     29     58  
Respiratory support @ randomization: Non-invasive ventilation  
[units: Participants]
     
Non-invasive ventilation: Yes     15     9     24  
Non-invasive ventilation: No     34     42     76  
Respiratory support @ randomization: Conventional mechanical ventilation  
[units: Participants]
     
Conventional mechanical ventilation: Yes     26     29     55  
Conventional mechanical ventilation: No     23     22     45  
Respiratory support @ randomization: High-frequency ventilation  
[units: Participants]
     
High-frequency ventilation: Yes     3     4     7  
High-frequency ventilation: No     46     47     93  
Respiratory support @ randomization: Inhaled nitric oxide  
[units: Participants]
     
Inhaled nitric oxide: Yes     2     4     6  
Inhaled nitric oxide: No     47     47     94  
Pressors at randomization  
[units: Participants]
     
Pressors used     3     4     7  
No pressors used     46     47     93  
Cord gas: pH  
[units: pH]
Mean (Standard Deviation)
  6.91  (0.20)     7.01  (0.15)     6.96  (0.18)  
Cord gas: base deficit  
[units: mEq/L]
Mean (Standard Deviation)
  15.6  (7.1)     14.0  (4.7)     14.8  (6.0)  
First postnatal gas: pH  
[units: pH]
Mean (Standard Deviation)
  7.06  (0.20)     7.02  (0.19)     7.04  (0.19)  
First postnatal gas: base deficit  
[units: mEq/L]
Mean (Standard Deviation)
  17.0  (6.7)     17.5  (6.9)     17.3  (6.8)  
[1] Chronological age at cooling initiation at birth hospital (hours)
[2] Apgar scores ≤5 at either 5 or 10 minutes can be due to acute hypoxia ischemia in the intrapartum period and as such are often one of the eligibility criteria for therapeutic hypothermia to treat HIE.



  Outcome Measures
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1.  Primary:   Percentage of Temperatures in Target Range During Transport   [ Time Frame: Participants will be followed for the duration of neonatal transport from the birth hospital to the cooling center, an expected average of 4 hours ]

2.  Secondary:   Time to Target Temperature   [ Time Frame: Participants will be followed for the duration of neonatal transport from the birth hospital to the cooling center, an expected average of 4 hours ]

3.  Secondary:   Percentage of Participants in the Target Range at 1 Hour   [ Time Frame: Participants will be followed for the duration of neonatal transport from the birth hospital to the cooling center, an expected average of 4 hours ]

4.  Secondary:   Participants in Target Temperature Range Anytime During Transport   [ Time Frame: Participants will be followed for the duration of neonatal transport from the birth hospital to the cooling center, an expected average of 4 hours ]

5.  Other Pre-specified:   Safety Outcomes   [ Time Frame: Participants will be followed for the duration of neonatal transport from the birth hospital to the cooling center, an expected average of 4 hours ]


  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
1, The criteria used to initiate hypothermia varied. 2, Operational errors occurred in 9 newborns during device regulated cooling. 3, 9.6% of temperatures in the control arm were missing.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Krisa P. Van Meurs, M.D.
Organization: Stanford University School of Medicine
phone: +1 650 723 5711
e-mail: vanmeurs@stanford.edu


Publications:

Publications automatically indexed to this study:

Responsible Party: Krisa P Van Meurs, Stanford University
ClinicalTrials.gov Identifier: NCT01683383     History of Changes
Other Study ID Numbers: 22993
Study First Received: September 6, 2012
Results First Received: November 21, 2014
Last Updated: December 1, 2014
Health Authority: United States: Food and Drug Administration