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Trial Outcomes & Findings for CoolCap Followup Study-Coordination of Participating Centers (NCT NCT00581581)

NCT ID: NCT00581581

Last Updated: 2013-03-08

Results Overview

WeeFIM instrument (the Functional Independence Measure for Children, Uniform Data System for Medical Rehabilitation, Buffalo, NY) is a set of ratings of 18 skills divided into 3 general domains: 8 Self-care; 5 Mobility; 5 Cognition. Caregivers rate a child about extent of independence, full functioning, in carrying out each of those 18 skills, on a scale from "1" for total assistance, total dependence, maximal prompting, or not testable to "7" for complete independence. The ratings are combined to yield 3 Domain scores and a WeeFIM Total. Favorable=mean+/-2SD. We are reporting the percentage of participants with a favorable response.

Recruitment status

COMPLETED

Target enrollment

62 participants

Primary outcome timeframe

7-8 years after initial intervention

Results posted on

2013-03-08

Participant Flow

Individuals who participated in the parent study (CoolCap) were invited to participate in this follow-up study when they were 7-8 years old. Site investigators contacted prior participants' families by phone for consent. Contact information for the families who consented was provided to a central examiner.

Observational study - determination of outcome at 7-8 years after prior randomization in parent study to therapeutic hypothermia vs standard of care for infants with hypoxic-ischemic encephalopathy who met eligibility requirements.

Participant milestones

Participant milestones
Measure
Therapeutic Hypothermia
Randomized to cooling (original RCT)
Standard Care
Randomized to standard care (original RCT)
Overall Study
STARTED
32
30
Overall Study
COMPLETED
32
30
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

CoolCap Followup Study-Coordination of Participating Centers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Therapeutic Hypothermia
n=32 Participants
Randomized to cooling (original RCT)
Standard Care
n=30 Participants
Randomized to standard care (original RCT)
Total
n=62 Participants
Total of all reporting groups
Age, Categorical
<=18 years
32 Participants
n=5 Participants
30 Participants
n=7 Participants
62 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age Continuous
7.68 years
STANDARD_DEVIATION 0.62 • n=5 Participants
7.66 years
STANDARD_DEVIATION 0.63 • n=7 Participants
7.67 years
STANDARD_DEVIATION 0.62 • n=5 Participants
Sex: Female, Male
Female
12 Participants
n=5 Participants
18 Participants
n=7 Participants
30 Participants
n=5 Participants
Sex: Female, Male
Male
20 Participants
n=5 Participants
12 Participants
n=7 Participants
32 Participants
n=5 Participants
Region of Enrollment
United Kingdom
6 participants
n=5 Participants
5 participants
n=7 Participants
11 participants
n=5 Participants
Region of Enrollment
United States
24 participants
n=5 Participants
23 participants
n=7 Participants
47 participants
n=5 Participants
Region of Enrollment
New Zealand
2 participants
n=5 Participants
2 participants
n=7 Participants
4 participants
n=5 Participants

PRIMARY outcome

Timeframe: 7-8 years after initial intervention

WeeFIM instrument (the Functional Independence Measure for Children, Uniform Data System for Medical Rehabilitation, Buffalo, NY) is a set of ratings of 18 skills divided into 3 general domains: 8 Self-care; 5 Mobility; 5 Cognition. Caregivers rate a child about extent of independence, full functioning, in carrying out each of those 18 skills, on a scale from "1" for total assistance, total dependence, maximal prompting, or not testable to "7" for complete independence. The ratings are combined to yield 3 Domain scores and a WeeFIM Total. Favorable=mean+/-2SD. We are reporting the percentage of participants with a favorable response.

Outcome measures

Outcome measures
Measure
Therapeutic Hypothermia
n=32 Participants
Randomized to cooling (original RCT)
Standard Care
n=30 Participants
Randomized to standard care (original RCT)
WeeFIM Score
78 percentage of participants
80 percentage of participants

Adverse Events

Therapeutic Hypothermia

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Standard Care

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ronnie Guillet, MD, PhD

University of Rochester

Phone: 585-275-6209

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place