Trial Outcomes & Findings for California Transport Cooling Trial (NCT NCT01683383)
NCT ID: NCT01683383
Last Updated: 2014-12-08
Results Overview
The percentage of temperatures in the target range (33°-34°C) during transport after cooling initiation by the transport team.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
101 participants
Primary outcome timeframe
Participants will be followed for the duration of neonatal transport from the birth hospital to the cooling center, an expected average of 4 hours
Results posted on
2014-12-08
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
51
|
|
Overall Study
Transported and Treated
|
49
|
51
|
|
Overall Study
COMPLETED
|
49
|
51
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Infant was not transported
|
1
|
0
|
Baseline Characteristics
California Transport Cooling Trial
Baseline characteristics by cohort
| Measure |
Control (Standard Cooling)
n=49 Participants
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)
n=51 Participants
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
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Chron. age at cooling initiation at birth hospital
|
26 Hours
STANDARD_DEVIATION 6 • n=5 Participants
|
28 Hours
STANDARD_DEVIATION 6 • n=7 Participants
|
27 Hours
STANDARD_DEVIATION 6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Birth weight
|
3397 Grams
STANDARD_DEVIATION 627 • n=5 Participants
|
3321 Grams
STANDARD_DEVIATION 523 • n=7 Participants
|
3358 Grams
STANDARD_DEVIATION 610 • n=5 Participants
|
|
Gestational age
|
39.1 Weeks
STANDARD_DEVIATION 1.7 • n=5 Participants
|
39.1 Weeks
STANDARD_DEVIATION 1.7 • n=7 Participants
|
39.1 Weeks
STANDARD_DEVIATION 1.7 • n=5 Participants
|
|
Apgar scores @ 1 minute
Apgar @ 1 min ≤ 5
|
47 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Apgar scores @ 1 minute
Apgar @ 1 min > 5
|
2 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Apgar scores @ 5 minutes
Apgar @ 5 min ≤ 5
|
42 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Apgar scores @ 5 minutes
Apgar @ 5 min > 5
|
7 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Apgar scores @ 10 minutes
Apgar @ 10 min ≤ 5
|
27 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Apgar scores @ 10 minutes
Apgar @ 10 min > 5
|
22 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Delivery room resuscitation: Oxygen
Oxygen
|
46 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Delivery room resuscitation: Oxygen
No oxygen
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Delivery room resuscitation: CPAP
CPAP
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Delivery room resuscitation: CPAP
No CPAP
|
31 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Delivery room resuscitation: Bag and mask
Bag and mask
|
43 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Delivery room resuscitation: Bag and mask
No bag and mask
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Delivery room resuscitation: Intubation with ventilation
Intubation with ventilation
|
34 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Delivery room resuscitation: Intubation with ventilation
No intubation with ventilation
|
15 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Delivery room resuscitation: Epinephrine
Epinephrine
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Delivery room resuscitation: Epinephrine
No epinephrine
|
36 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Delivery room resuscitation: Chest compressions
Chest compressions
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Delivery room resuscitation: Chest compressions
No chest compressions
|
29 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Respiratory support @ randomization: Non-invasive ventilation
Non-invasive ventilation: Yes
|
15 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Respiratory support @ randomization: Non-invasive ventilation
Non-invasive ventilation: No
|
34 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Respiratory support @ randomization: Conventional mechanical ventilation
Conventional mechanical ventilation: Yes
|
26 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Respiratory support @ randomization: Conventional mechanical ventilation
Conventional mechanical ventilation: No
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Respiratory support @ randomization: High-frequency ventilation
High-frequency ventilation: Yes
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Respiratory support @ randomization: High-frequency ventilation
High-frequency ventilation: No
|
46 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Respiratory support @ randomization: Inhaled nitric oxide
Inhaled nitric oxide: Yes
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Respiratory support @ randomization: Inhaled nitric oxide
Inhaled nitric oxide: No
|
47 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Pressors at randomization
Pressors used
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Pressors at randomization
No pressors used
|
46 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Cord gas: pH
|
6.91 pH
STANDARD_DEVIATION 0.20 • n=5 Participants
|
7.01 pH
STANDARD_DEVIATION 0.15 • n=7 Participants
|
6.96 pH
STANDARD_DEVIATION 0.18 • n=5 Participants
|
|
Cord gas: base deficit
|
15.6 mEq/L
STANDARD_DEVIATION 7.1 • n=5 Participants
|
14.0 mEq/L
STANDARD_DEVIATION 4.7 • n=7 Participants
|
14.8 mEq/L
STANDARD_DEVIATION 6.0 • n=5 Participants
|
|
First postnatal gas: pH
|
7.06 pH
STANDARD_DEVIATION 0.20 • n=5 Participants
|
7.02 pH
STANDARD_DEVIATION 0.19 • n=7 Participants
|
7.04 pH
STANDARD_DEVIATION 0.19 • n=5 Participants
|
|
First postnatal gas: base deficit
|
17.0 mEq/L
STANDARD_DEVIATION 6.7 • n=5 Participants
|
17.5 mEq/L
STANDARD_DEVIATION 6.9 • n=7 Participants
|
17.3 mEq/L
STANDARD_DEVIATION 6.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: Participants will be followed for the duration of neonatal transport from the birth hospital to the cooling center, an expected average of 4 hoursPopulation: Total patients in each study arm
The percentage of temperatures in the target range (33°-34°C) during transport after cooling initiation by the transport team.
Outcome measures
| Measure |
Control (Standard Cooling)
n=49 Participants
Subjects in Arm 1 will receive passive or active cooling as per center practice with rectal temperatures being recorded every 15 minutes.
|
Device (Servo-regulated Cooling)
n=51 Participants
Subjects in Arm 2 will be placed on cooling blanket connected to the Tecotherm Neo (Inspiration Healthcare LTD UK). Temperature will be monitored continuously and servo-regulated using a rectal temperature probe.
|
|---|---|---|
|
Percentage of Temperatures in Target Range During Transport
|
0 Percentage of temperatures
Interval 0.0 to 52.0
|
73 Percentage of temperatures
Interval 17.0 to 88.0
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of neonatal transport from the birth hospital to the cooling center, an expected average of 4 hoursPopulation: Total patients in each study arm
Time to the target temperature range (33°-34°C) from initiation of cooling by the transport team
Outcome measures
| Measure |
Control (Standard Cooling)
n=49 Participants
Subjects in Arm 1 will receive passive or active cooling as per center practice with rectal temperatures being recorded every 15 minutes.
|
Device (Servo-regulated Cooling)
n=51 Participants
Subjects in Arm 2 will be placed on cooling blanket connected to the Tecotherm Neo (Inspiration Healthcare LTD UK). Temperature will be monitored continuously and servo-regulated using a rectal temperature probe.
|
|---|---|---|
|
Time to Target Temperature
|
63 Minutes
Standard Deviation 37
|
44 Minutes
Standard Deviation 31
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of neonatal transport from the birth hospital to the cooling center, an expected average of 4 hoursPopulation: Total participants in each study arm, excluding 8 participants in the control arm and 12 participants in the device arm who completed transport in \< 1 hour.
Percentage of participants in target range (33°-34°C) one hour after cooling initiation by the transport team
Outcome measures
| Measure |
Control (Standard Cooling)
n=41 Participants
Subjects in Arm 1 will receive passive or active cooling as per center practice with rectal temperatures being recorded every 15 minutes.
|
Device (Servo-regulated Cooling)
n=39 Participants
Subjects in Arm 2 will be placed on cooling blanket connected to the Tecotherm Neo (Inspiration Healthcare LTD UK). Temperature will be monitored continuously and servo-regulated using a rectal temperature probe.
|
|---|---|---|
|
Percentage of Participants in the Target Range at 1 Hour
|
8 Percentage of participants
|
28 Percentage of participants
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of neonatal transport from the birth hospital to the cooling center, an expected average of 4 hoursPopulation: Total participants in each study arm
Participants in target temperature range (33-34 C) anytime during transport
Outcome measures
| Measure |
Control (Standard Cooling)
n=49 Participants
Subjects in Arm 1 will receive passive or active cooling as per center practice with rectal temperatures being recorded every 15 minutes.
|
Device (Servo-regulated Cooling)
n=51 Participants
Subjects in Arm 2 will be placed on cooling blanket connected to the Tecotherm Neo (Inspiration Healthcare LTD UK). Temperature will be monitored continuously and servo-regulated using a rectal temperature probe.
|
|---|---|---|
|
Participants in Target Temperature Range Anytime During Transport
|
24 Participants
|
41 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants will be followed for the duration of neonatal transport from the birth hospital to the cooling center, an expected average of 4 hoursPopulation: Total participants in each study arm
The incidence, intervention and outcome of cardiac arrhythmia, major bleeding, altered skin integrity, pulmonary hypertension, device-related events, death, and other serious adverse events from the time of initiation of transport cooling to the time of completion will be monitored.
Outcome measures
| Measure |
Control (Standard Cooling)
n=49 Participants
Subjects in Arm 1 will receive passive or active cooling as per center practice with rectal temperatures being recorded every 15 minutes.
|
Device (Servo-regulated Cooling)
n=51 Participants
Subjects in Arm 2 will be placed on cooling blanket connected to the Tecotherm Neo (Inspiration Healthcare LTD UK). Temperature will be monitored continuously and servo-regulated using a rectal temperature probe.
|
|---|---|---|
|
Safety Outcomes
Cardiac arrhythmia
|
0 Participants
|
0 Participants
|
|
Safety Outcomes
Major bleeding (pulmonary hemorrhage)
|
0 Participants
|
1 Participants
|
|
Safety Outcomes
Altered skin integrity
|
0 Participants
|
0 Participants
|
|
Safety Outcomes
Pulmonary hypertension
|
0 Participants
|
0 Participants
|
|
Safety Outcomes
Device-related events
|
0 Participants
|
2 Participants
|
|
Safety Outcomes
Death
|
6 Participants
|
9 Participants
|
Adverse Events
Control (Standard Cooling)
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
Device (Servo-regulated Cooling)
Serious events: 10 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control (Standard Cooling)
n=49 participants at risk
Subjects in Arm 1 will receive passive or active cooling as per center practice with rectal temperatures being recorded every 15 minutes.
|
Device (Servo-regulated Cooling)
n=51 participants at risk
Subjects in Arm 2 will be placed on cooling blanket connected to the Tecotherm Neo (Inspiration Healthcare LTD UK). Temperature will be monitored continuously and servo-regulated using a rectal temperature probe.
|
|---|---|---|
|
Vascular disorders
Pulmonary hemorrhage
|
0.00%
0/49 • Data were collected from the time of initiation of cooling (Arm 1 or Arm 2) to admission at the cooling center
|
2.0%
1/51 • Number of events 1 • Data were collected from the time of initiation of cooling (Arm 1 or Arm 2) to admission at the cooling center
|
|
General disorders
Death
|
12.2%
6/49 • Number of events 6 • Data were collected from the time of initiation of cooling (Arm 1 or Arm 2) to admission at the cooling center
|
17.6%
9/51 • Number of events 9 • Data were collected from the time of initiation of cooling (Arm 1 or Arm 2) to admission at the cooling center
|
Other adverse events
| Measure |
Control (Standard Cooling)
n=49 participants at risk
Subjects in Arm 1 will receive passive or active cooling as per center practice with rectal temperatures being recorded every 15 minutes.
|
Device (Servo-regulated Cooling)
n=51 participants at risk
Subjects in Arm 2 will be placed on cooling blanket connected to the Tecotherm Neo (Inspiration Healthcare LTD UK). Temperature will be monitored continuously and servo-regulated using a rectal temperature probe.
|
|---|---|---|
|
General disorders
Equipment alarms
|
0.00%
0/49 • Data were collected from the time of initiation of cooling (Arm 1 or Arm 2) to admission at the cooling center
|
3.9%
2/51 • Number of events 2 • Data were collected from the time of initiation of cooling (Arm 1 or Arm 2) to admission at the cooling center
|
Additional Information
Krisa P. Van Meurs, M.D.
Stanford University School of Medicine
Phone: +1 650 723 5711
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place