Trial Outcomes & Findings for Optimizing (Longer, Deeper) Cooling for Neonatal Hypoxic-Ischemic Encephalopathy(HIE) (NCT NCT01192776)
NCT ID: NCT01192776
Last Updated: 2025-11-28
Results Overview
Death includes any mortality prior to follow up at 18-22 months. Severe disability was defined by any of the following: a Bayley III cognitive score \<70, a GMFCS level of 3-5, blindness or profound hearing loss (inability to understand commands despite amplification). Moderate disability was defined as a Bayley cognitive score of 70-84 and either a GMFCS level of 2, seizure disorder, or a hearing deficit requiring amplification to understand commands.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
364 participants
Primary outcome timeframe
Birth to 22 months corrected age
Results posted on
2025-11-28
Participant Flow
1261 infants assessed for eligibility. 897 were excluded for not meeting eligibility criteria (N=747) or not having parental or physician consent (N=150).
All eligible infants with consent were randomized to one of four treatment arms/groups.
Participant milestones
| Measure |
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
95
|
90
|
96
|
83
|
|
Overall Study
Died Prior to Discharge
|
7
|
13
|
15
|
14
|
|
Overall Study
Died After Discharge
|
1
|
2
|
3
|
1
|
|
Overall Study
COMPLETED
|
84
|
69
|
75
|
63
|
|
Overall Study
NOT COMPLETED
|
11
|
21
|
21
|
20
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|---|---|
|
Overall Study
Death
|
8
|
15
|
18
|
15
|
|
Overall Study
Lost to Follow-up
|
3
|
6
|
3
|
5
|
Baseline Characteristics
Data was missing for one participant.
Baseline characteristics by cohort
| Measure |
33.5°C for 72 Hours
n=95 Participants
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
n=90 Participants
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
n=96 Participants
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
n=83 Participants
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
n=364 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Level of encephalopathy
Severe
|
21 Participants
n=95 Participants
|
20 Participants
n=90 Participants
|
18 Participants
n=96 Participants
|
25 Participants
n=83 Participants
|
84 Participants
n=364 Participants
|
|
Age, Continuous
|
5.1 hours
STANDARD_DEVIATION 1.0 • n=95 Participants • Data was missing for one participant.
|
4.9 hours
STANDARD_DEVIATION 1.2 • n=90 Participants • Data was missing for one participant.
|
4.8 hours
STANDARD_DEVIATION 1.1 • n=95 Participants • Data was missing for one participant.
|
5.0 hours
STANDARD_DEVIATION 1.6 • n=83 Participants • Data was missing for one participant.
|
4.9 hours
STANDARD_DEVIATION 1.2 • n=363 Participants • Data was missing for one participant.
|
|
Sex/Gender, Customized
Male
|
52 Participants
n=95 Participants
|
53 Participants
n=90 Participants
|
51 Participants
n=96 Participants
|
56 Participants
n=83 Participants
|
212 Participants
n=364 Participants
|
|
Sex/Gender, Customized
Female
|
43 Participants
n=95 Participants
|
37 Participants
n=90 Participants
|
44 Participants
n=96 Participants
|
27 Participants
n=83 Participants
|
151 Participants
n=364 Participants
|
|
Sex/Gender, Customized
Ambiguous
|
0 Participants
n=95 Participants
|
0 Participants
n=90 Participants
|
1 Participants
n=96 Participants
|
0 Participants
n=83 Participants
|
1 Participants
n=364 Participants
|
|
Race/Ethnicity, Customized
Black
|
29 Participants
n=95 Participants • Data was missing for six participants.
|
28 Participants
n=89 Participants • Data was missing for six participants.
|
32 Participants
n=94 Participants • Data was missing for six participants.
|
25 Participants
n=80 Participants • Data was missing for six participants.
|
114 Participants
n=358 Participants • Data was missing for six participants.
|
|
Race/Ethnicity, Customized
White
|
60 Participants
n=95 Participants • Data was missing for six participants.
|
56 Participants
n=89 Participants • Data was missing for six participants.
|
55 Participants
n=94 Participants • Data was missing for six participants.
|
48 Participants
n=80 Participants • Data was missing for six participants.
|
219 Participants
n=358 Participants • Data was missing for six participants.
|
|
Race/Ethnicity, Customized
Other
|
6 Participants
n=95 Participants • Data was missing for six participants.
|
5 Participants
n=89 Participants • Data was missing for six participants.
|
7 Participants
n=94 Participants • Data was missing for six participants.
|
7 Participants
n=80 Participants • Data was missing for six participants.
|
25 Participants
n=358 Participants • Data was missing for six participants.
|
|
Birthweight
|
3230 grams
STANDARD_DEVIATION 528 • n=95 Participants • Data was missing for one participant.
|
3360 grams
STANDARD_DEVIATION 544 • n=90 Participants • Data was missing for one participant.
|
3354 grams
STANDARD_DEVIATION 676 • n=95 Participants • Data was missing for one participant.
|
3511 grams
STANDARD_DEVIATION 615 • n=83 Participants • Data was missing for one participant.
|
3359 grams
STANDARD_DEVIATION 599 • n=363 Participants • Data was missing for one participant.
|
|
Level of encephalopathy
Moderate
|
74 Participants
n=95 Participants
|
70 Participants
n=90 Participants
|
78 Participants
n=96 Participants
|
58 Participants
n=83 Participants
|
280 Participants
n=364 Participants
|
PRIMARY outcome
Timeframe: Birth to 22 months corrected agePopulation: Includes all deaths and all infants followed at 18-22 months. Does not include 17 infants lost to follow up.
Death includes any mortality prior to follow up at 18-22 months. Severe disability was defined by any of the following: a Bayley III cognitive score \<70, a GMFCS level of 3-5, blindness or profound hearing loss (inability to understand commands despite amplification). Moderate disability was defined as a Bayley cognitive score of 70-84 and either a GMFCS level of 2, seizure disorder, or a hearing deficit requiring amplification to understand commands.
Outcome measures
| Measure |
32.0°C for 120 Hours
n=78 Participants
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.
|
33.5°C for 72 Hours
n=92 Participants
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.
|
33.5°C for 120 Hours
n=93 Participants
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 72 Hours
n=84 Participants
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.
|
|---|---|---|---|---|
|
Death or Moderate to Severe Disability
|
22 Participants
|
27 Participants
|
32 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: Birth to 22 months corrected agePopulation: Includes all deaths and all infants followed at 18-22 months. Does not include 17 infants lost to follow up.
Death includes any mortality prior to follow up at 18-22 months.
Outcome measures
| Measure |
32.0°C for 120 Hours
n=78 Participants
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.
|
33.5°C for 72 Hours
n=92 Participants
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.
|
33.5°C for 120 Hours
n=93 Participants
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 72 Hours
n=84 Participants
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.
|
|---|---|---|---|---|
|
Death
|
15 Participants
|
8 Participants
|
18 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Follow up at 18-22 months corrected agePopulation: Includes all infants followed at 18-22 months except for 6 infants who could not be distinguished between normal and mild. Does not include 17 infants lost to follow up or 56 deaths
Among survivors number of normal infants and infants with mild, moderate, and severe disability Severe disability was defined by any of the following: a Bayley III cognitive score \<70, a GMFCS level of 3-5, blindness or profound hearing loss (inability to understand commands despite amplification). Moderate disability was defined as a Bayley cognitive score of 70-84 and either a GMFCS level of 2, seizure disorder, or a hearing deficit requiring amplification to understand commands. Mild impairment was defined by a cognitive score 70-84, or a cognitive score ≥ 85 and any of the following: presence of a GMFCS level 1 or 2, seizure disorder or hearing loss not requiring amplification. Normal was defined by a cognitive score ≥ 85 in the absence of any neurosensory deficits or seizures after NICU discharge.
Outcome measures
| Measure |
32.0°C for 120 Hours
n=63 Participants
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.
|
33.5°C for 72 Hours
n=81 Participants
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.
|
33.5°C for 120 Hours
n=72 Participants
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 72 Hours
n=69 Participants
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.
|
|---|---|---|---|---|
|
Level of Disability Among Survivors
Severe disability
|
7 Participants
|
18 Participants
|
14 Participants
|
11 Participants
|
|
Level of Disability Among Survivors
Moderate disability
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Level of Disability Among Survivors
Mild disability
|
18 Participants
|
16 Participants
|
22 Participants
|
15 Participants
|
|
Level of Disability Among Survivors
Normal
|
38 Participants
|
46 Participants
|
36 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: Birth through hospital discharge, average 22 days.Number of infants for whom aggressive care is withdrawn
Outcome measures
| Measure |
32.0°C for 120 Hours
n=83 Participants
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.
|
33.5°C for 72 Hours
n=95 Participants
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.
|
33.5°C for 120 Hours
n=96 Participants
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 72 Hours
n=90 Participants
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.
|
|---|---|---|---|---|
|
Withdrawal of Care
|
13 Participants
|
6 Participants
|
14 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Through death, discharge, or transferDocumented seizures during hospital course
Outcome measures
| Measure |
32.0°C for 120 Hours
n=83 Participants
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.
|
33.5°C for 72 Hours
n=95 Participants
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.
|
33.5°C for 120 Hours
n=96 Participants
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 72 Hours
n=90 Participants
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.
|
|---|---|---|---|---|
|
Clinical Neonatal Seizures
|
40 Participants
|
50 Participants
|
44 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: Follow up at 18-22 months corrected agePopulation: Infants who survived and were followed at 18-22 months
Bayley Scale of Infant Development Composite Cognitive Score. The total composite score is reported, ranging from the lowest score of 55 to the highest score of 145. Lower values specify worse outcome.
Outcome measures
| Measure |
32.0°C for 120 Hours
n=63 Participants
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.
|
33.5°C for 72 Hours
n=78 Participants
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.
|
33.5°C for 120 Hours
n=73 Participants
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 72 Hours
n=69 Participants
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.
|
|---|---|---|---|---|
|
Bayley Cognitive Score
|
90 scores on a scale
Interval 80.0 to 95.0
|
90 scores on a scale
Interval 80.0 to 100.0
|
90 scores on a scale
Interval 80.0 to 100.0
|
90 scores on a scale
Interval 75.0 to 100.0
|
SECONDARY outcome
Timeframe: Follow up at 18-22 months corrected agePopulation: Infants who survived and were followed at 18-22 months
Outcome measures
| Measure |
32.0°C for 120 Hours
n=63 Participants
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.
|
33.5°C for 72 Hours
n=83 Participants
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.
|
33.5°C for 120 Hours
n=75 Participants
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 72 Hours
n=69 Participants
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.
|
|---|---|---|---|---|
|
Cerebral Palsy
|
8 Participants
|
15 Participants
|
10 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Follow up at 18-22 months corrected agePopulation: Includes all infants followed at 18-22 months, except for 6 infants who could not be distinguished between normal and mild. Does not include 17 infants lost to follow up or 56 deaths.
Among survivors, number of normal infants and infants with mild, moderate and severe disability Severe disability was defined by any of the following: a Bayley III cognitive score \<70, a GMFCS level of 3-5, blindness or profound hearing loss (inability to understand commands despite amplification). Moderate disability was defined as a Bayley cognitive score of 70-84 and either a GMFCS level of 2, seizure disorder, or a hearing deficit requiring amplification to understand commands. Mild impairment was defined by a cognitive score 70-84, or a cognitive score ≥ 85 and any of the following: presence of a GMFCS level 1 or 2, seizure disorder or hearing loss not requiring amplification. Normal was defined by a cognitive score ≥ 85 in the absence of any neurosensory deficits or seizures after NICU discharge.
Outcome measures
| Measure |
32.0°C for 120 Hours
n=63 Participants
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.
|
33.5°C for 72 Hours
n=81 Participants
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.
|
33.5°C for 120 Hours
n=72 Participants
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 72 Hours
n=69 Participants
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.
|
|---|---|---|---|---|
|
Level of Disability Among Survivors, by Level of HIE
Moderate HIE · Normal
|
31 Participants
|
41 Participants
|
34 Participants
|
39 Participants
|
|
Level of Disability Among Survivors, by Level of HIE
Moderate HIE · Mild disability
|
13 Participants
|
13 Participants
|
19 Participants
|
12 Participants
|
|
Level of Disability Among Survivors, by Level of HIE
Moderate HIE · Moderate disability
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Level of Disability Among Survivors, by Level of HIE
Moderate HIE · Severe disability
|
5 Participants
|
9 Participants
|
12 Participants
|
7 Participants
|
|
Level of Disability Among Survivors, by Level of HIE
Severe HIE · Normal
|
7 Participants
|
5 Participants
|
2 Participants
|
1 Participants
|
|
Level of Disability Among Survivors, by Level of HIE
Severe HIE · Mild disability
|
5 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
|
Level of Disability Among Survivors, by Level of HIE
Severe HIE · Moderate disability
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Level of Disability Among Survivors, by Level of HIE
Severe HIE · Severe disability
|
2 Participants
|
9 Participants
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Follow up at 18-22 months corrected agePopulation: Infants who survived and were followed at 18-22 months
Visual impairment is defined as bilateral blindness with some/no useful vision
Outcome measures
| Measure |
32.0°C for 120 Hours
n=63 Participants
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.
|
33.5°C for 72 Hours
n=83 Participants
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.
|
33.5°C for 120 Hours
n=75 Participants
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 72 Hours
n=69 Participants
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.
|
|---|---|---|---|---|
|
Visual Impairment
|
4 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Follow up at 18-22 months corrected agePopulation: Infants who survived and were followed at 18-22 months
Hearing impairment is defined as hearing impairment despite amplification
Outcome measures
| Measure |
32.0°C for 120 Hours
n=63 Participants
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.
|
33.5°C for 72 Hours
n=83 Participants
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.
|
33.5°C for 120 Hours
n=75 Participants
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 72 Hours
n=69 Participants
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.
|
|---|---|---|---|---|
|
Hearing Impairment
|
1 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Follow up at 18-22 months corrected agePopulation: Infants who survived and were followed at 18-22 months
Multiple disabilities is defined as two or more of the following 5 components: disabling CP, GMFCS level 3-5, Bayley cognitive score \< 70, blindness, or deafness.
Outcome measures
| Measure |
32.0°C for 120 Hours
n=63 Participants
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.
|
33.5°C for 72 Hours
n=84 Participants
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.
|
33.5°C for 120 Hours
n=75 Participants
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 72 Hours
n=69 Participants
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.
|
|---|---|---|---|---|
|
Multiple Disabilities
|
5 Participants
|
14 Participants
|
7 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Until death, discharge, or transferPopulation: No patients were analyzed for this outcome as the study was terminated early and no additional funds available to complete this complex analysis.
The data needed for this analysis are not collected directly, and will not be analyzed as the study was terminated early and no funds available to complete this complex analysis. The data for this study will be stored at the NICHD-DASH for investigators.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 7-14 days of lifePopulation: Note that 66 infants are not included (total N for OC study=364); 49 were excluded due to lack of MRI of adequate quality, 16 due to missing primary outcome, and 1 due to genetic abnormality.
Total hemispheric devastation based on MRI taken between 7-14 days of life
Outcome measures
| Measure |
32.0°C for 120 Hours
n=61 Participants
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.
|
33.5°C for 72 Hours
n=82 Participants
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.
|
33.5°C for 120 Hours
n=80 Participants
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 72 Hours
n=75 Participants
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.
|
|---|---|---|---|---|
|
Severe Neonatal Brain Abnormalities
Total hemispheric devastation = YES
|
7 Participants
|
10 Participants
|
4 Participants
|
11 Participants
|
|
Severe Neonatal Brain Abnormalities
Total hemispheric devastation = NO
|
54 Participants
|
72 Participants
|
76 Participants
|
64 Participants
|
Adverse Events
33.5°C for 72 Hours
Serious events: 10 serious events
Other events: 5 other events
Deaths: 8 deaths
32.0°C for 72 Hours
Serious events: 15 serious events
Other events: 3 other events
Deaths: 15 deaths
33.5°C for 120 Hours
Serious events: 11 serious events
Other events: 6 other events
Deaths: 18 deaths
32.0°C for 120 Hours
Serious events: 23 serious events
Other events: 9 other events
Deaths: 15 deaths
Serious adverse events
| Measure |
33.5°C for 72 Hours
n=95 participants at risk
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
n=90 participants at risk
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
n=96 participants at risk
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
n=83 participants at risk
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.
|
|---|---|---|---|---|
|
Nervous system disorders
Death during intervention
|
5.3%
5/95 • Number of events 5 • During study intervention period: 72 or 120 hours from baseline, based on treatment arm
17 infants lost to follow up were excluded from the All-Cause Mortality table. Mortality cannot be assessed for infants lost to follow up.
|
5.6%
5/90 • Number of events 5 • During study intervention period: 72 or 120 hours from baseline, based on treatment arm
17 infants lost to follow up were excluded from the All-Cause Mortality table. Mortality cannot be assessed for infants lost to follow up.
|
7.3%
7/96 • Number of events 7 • During study intervention period: 72 or 120 hours from baseline, based on treatment arm
17 infants lost to follow up were excluded from the All-Cause Mortality table. Mortality cannot be assessed for infants lost to follow up.
|
14.5%
12/83 • Number of events 12 • During study intervention period: 72 or 120 hours from baseline, based on treatment arm
17 infants lost to follow up were excluded from the All-Cause Mortality table. Mortality cannot be assessed for infants lost to follow up.
|
|
Cardiac disorders
Cardiac Arrythmia
|
1.1%
1/95 • Number of events 1 • During study intervention period: 72 or 120 hours from baseline, based on treatment arm
17 infants lost to follow up were excluded from the All-Cause Mortality table. Mortality cannot be assessed for infants lost to follow up.
|
1.1%
1/90 • Number of events 1 • During study intervention period: 72 or 120 hours from baseline, based on treatment arm
17 infants lost to follow up were excluded from the All-Cause Mortality table. Mortality cannot be assessed for infants lost to follow up.
|
1.0%
1/96 • Number of events 1 • During study intervention period: 72 or 120 hours from baseline, based on treatment arm
17 infants lost to follow up were excluded from the All-Cause Mortality table. Mortality cannot be assessed for infants lost to follow up.
|
8.4%
7/83 • Number of events 9 • During study intervention period: 72 or 120 hours from baseline, based on treatment arm
17 infants lost to follow up were excluded from the All-Cause Mortality table. Mortality cannot be assessed for infants lost to follow up.
|
|
Nervous system disorders
Thrombosis
|
0.00%
0/95 • During study intervention period: 72 or 120 hours from baseline, based on treatment arm
17 infants lost to follow up were excluded from the All-Cause Mortality table. Mortality cannot be assessed for infants lost to follow up.
|
0.00%
0/90 • During study intervention period: 72 or 120 hours from baseline, based on treatment arm
17 infants lost to follow up were excluded from the All-Cause Mortality table. Mortality cannot be assessed for infants lost to follow up.
|
0.00%
0/96 • During study intervention period: 72 or 120 hours from baseline, based on treatment arm
17 infants lost to follow up were excluded from the All-Cause Mortality table. Mortality cannot be assessed for infants lost to follow up.
|
1.2%
1/83 • Number of events 1 • During study intervention period: 72 or 120 hours from baseline, based on treatment arm
17 infants lost to follow up were excluded from the All-Cause Mortality table. Mortality cannot be assessed for infants lost to follow up.
|
|
Nervous system disorders
Major Bleeding
|
3.2%
3/95 • Number of events 3 • During study intervention period: 72 or 120 hours from baseline, based on treatment arm
17 infants lost to follow up were excluded from the All-Cause Mortality table. Mortality cannot be assessed for infants lost to follow up.
|
2.2%
2/90 • Number of events 2 • During study intervention period: 72 or 120 hours from baseline, based on treatment arm
17 infants lost to follow up were excluded from the All-Cause Mortality table. Mortality cannot be assessed for infants lost to follow up.
|
1.0%
1/96 • Number of events 1 • During study intervention period: 72 or 120 hours from baseline, based on treatment arm
17 infants lost to follow up were excluded from the All-Cause Mortality table. Mortality cannot be assessed for infants lost to follow up.
|
1.2%
1/83 • Number of events 1 • During study intervention period: 72 or 120 hours from baseline, based on treatment arm
17 infants lost to follow up were excluded from the All-Cause Mortality table. Mortality cannot be assessed for infants lost to follow up.
|
|
General disorders
Other
|
5.3%
5/95 • Number of events 7 • During study intervention period: 72 or 120 hours from baseline, based on treatment arm
17 infants lost to follow up were excluded from the All-Cause Mortality table. Mortality cannot be assessed for infants lost to follow up.
|
11.1%
10/90 • Number of events 10 • During study intervention period: 72 or 120 hours from baseline, based on treatment arm
17 infants lost to follow up were excluded from the All-Cause Mortality table. Mortality cannot be assessed for infants lost to follow up.
|
6.2%
6/96 • Number of events 7 • During study intervention period: 72 or 120 hours from baseline, based on treatment arm
17 infants lost to follow up were excluded from the All-Cause Mortality table. Mortality cannot be assessed for infants lost to follow up.
|
13.3%
11/83 • Number of events 16 • During study intervention period: 72 or 120 hours from baseline, based on treatment arm
17 infants lost to follow up were excluded from the All-Cause Mortality table. Mortality cannot be assessed for infants lost to follow up.
|
Other adverse events
| Measure |
33.5°C for 72 Hours
n=95 participants at risk
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
n=90 participants at risk
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
n=96 participants at risk
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
n=83 participants at risk
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.
|
|---|---|---|---|---|
|
General disorders
Metabolic acidosis developing >3 hours after initiation of intervention and persisting >3 hours
|
2.1%
2/95 • Number of events 3 • During study intervention period: 72 or 120 hours from baseline, based on treatment arm
17 infants lost to follow up were excluded from the All-Cause Mortality table. Mortality cannot be assessed for infants lost to follow up.
|
0.00%
0/90 • During study intervention period: 72 or 120 hours from baseline, based on treatment arm
17 infants lost to follow up were excluded from the All-Cause Mortality table. Mortality cannot be assessed for infants lost to follow up.
|
1.0%
1/96 • Number of events 1 • During study intervention period: 72 or 120 hours from baseline, based on treatment arm
17 infants lost to follow up were excluded from the All-Cause Mortality table. Mortality cannot be assessed for infants lost to follow up.
|
4.8%
4/83 • Number of events 4 • During study intervention period: 72 or 120 hours from baseline, based on treatment arm
17 infants lost to follow up were excluded from the All-Cause Mortality table. Mortality cannot be assessed for infants lost to follow up.
|
|
Musculoskeletal and connective tissue disorders
Alteration of Skin Integrity
|
3.2%
3/95 • Number of events 3 • During study intervention period: 72 or 120 hours from baseline, based on treatment arm
17 infants lost to follow up were excluded from the All-Cause Mortality table. Mortality cannot be assessed for infants lost to follow up.
|
3.3%
3/90 • Number of events 3 • During study intervention period: 72 or 120 hours from baseline, based on treatment arm
17 infants lost to follow up were excluded from the All-Cause Mortality table. Mortality cannot be assessed for infants lost to follow up.
|
5.2%
5/96 • Number of events 8 • During study intervention period: 72 or 120 hours from baseline, based on treatment arm
17 infants lost to follow up were excluded from the All-Cause Mortality table. Mortality cannot be assessed for infants lost to follow up.
|
6.0%
5/83 • Number of events 5 • During study intervention period: 72 or 120 hours from baseline, based on treatment arm
17 infants lost to follow up were excluded from the All-Cause Mortality table. Mortality cannot be assessed for infants lost to follow up.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Investigators must adhere to the Neonatal Research Network Publication policies.
- Publication restrictions are in place
Restriction type: OTHER