Neonatal Encephalopathy
Conditions
Keywords
neonatal encephalopathy, therapeutic hypothermia, head cooling, neonatal asphyxia
Brief summary
This observational study will assess long-term functional outcome of survivors from neonatal encephalopathy who were previously treated with either head cooling or with conventional care in a randomized clinical trial. Children's parents will be interviewed by phone by trained staff using the WeeFIM questionnaire to ascertain the childrens' functional performance on a set of skills basic to daily life. This instrument is able to assess a very wide range of abilities, from independently functioning to needing total assistance. The ratings will be used to examine the relationship between the outcome previously measured at 18 months age and functional outcome at school age and to triage the children into those who clearly could not be tested on standardized exams of cognitive functioning, those who potentially could, even if at a low level of cognitive ability, and those who appear to be functioning at an age-appropriate level.
Detailed description
Previous studies have demonstrated that hypothermia for hypoxic-ischemic encephalopathy in the neonatal period is generally safe and feasible, and can improve intermediate term survival without handicap. There is, however, no information on whether cooling improves longer term (school-age) outcomes in non-handicapped survivors. The current observational trial is designed to help obtain additional followup information on children who participated in the initial randomized clinical trial of head-cooling for neonatal encephalopathy. A first step is to collect information on the current status (at 7-8 years of age) of participants in the original study using a standardized telephone questionnaire. This will allow the investigators to more appropriately target children for whom further, more detailed, in-person neurodevelopmental testing would be appropriate. Given limited resources, identification of children for whom such testing would be helpful and instructive is a necessary goal.
Interventions
None listed
Sponsors
Olympic Medical
University of Rochester
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 8 Years
Healthy volunteers
No
Inclusion criteria
* Previous participation in the CoolCap study * Survivors to 7-8 years of age * Parental consent to participation
Exclusion criteria
* Lack of parental consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| WeeFIM Score | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Therapeutic Hypothermia Randomized to cooling (original RCT) | 32 |
| Standard Care Randomized to standard care (original RCT) | 30 |
| Total | 62 |
Baseline characteristics
| Characteristic | Therapeutic Hypothermia | Standard Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 32 Participants | 30 Participants | 62 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age Continuous | 7.68 years STANDARD_DEVIATION 0.62 | 7.66 years STANDARD_DEVIATION 0.63 | 7.67 years STANDARD_DEVIATION 0.62 |
| Region of Enrollment New Zealand | 2 participants | 2 participants | 4 participants |
| Region of Enrollment United Kingdom | 6 participants | 5 participants | 11 participants |
| Region of Enrollment United States | 24 participants | 23 participants | 47 participants |
| Sex: Female, Male Female | 12 Participants | 18 Participants | 30 Participants |
| Sex: Female, Male Male | 20 Participants | 12 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
WeeFIM Score
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.
Time frame: 7-8 years after initial intervention
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Therapeutic Hypothermia | WeeFIM Score | 78 percentage of participants |
| Standard Care | WeeFIM Score | 80 percentage of participants |