Hypothermia for perinatal asphyxia: trial-based quality of life at 6-7 years
Helen Campbell1, Oya Eddama1, Denis Azzopardi2,3
1National Perinatal Epidemiology Unit (NPEU), Nuffield Department of Population Health, University of Oxford, Oxford, UK.
Insights
Hypothermia treatment at birth showed a trend towards better health-related quality of life (HRQL) in children, though speech was disproportionately affected. This study offers insights into long-term HRQL after neonatal encephalopathy.
Area of Science:
- Neonatal care and neuroprotection
- Pediatric health outcomes
- Quality of life research
Background:
- Perinatal asphyxial encephalopathy can impact long-term neurodevelopment and quality of life.
- Hypothermic neural rescue is a therapeutic strategy aimed at mitigating brain injury in neonates.
Purpose of the Study:
- To evaluate the long-term health-related quality of life (HRQL) in children who received hypothermic neural rescue at birth.
- To assess the impact of neonatal hypothermia on various HRQL domains in middle childhood.
Main Methods:
- A 6-7 year follow-up of surviving children from the Total Body Hypothermia for Neonatal Encephalopathy (TOBY) Trial.
- Utilized a community-based study with parental questionnaires to collect HRQL data using the Health Utilities Index (HUI).
- Compared 75 children in the hypothermia group with 70 children in the control group.
Main Results:
- Children in the hypothermia group had a mean HUI3 HRQL score of 0.73 compared to 0.62 in the control group, indicating a trend favoring hypothermia.
- Speech was disproportionately affected in the hypothermia group compared to other HRQL aspects.
- Levels of normal emotional functioning were similar between the hypothermia and control groups.
Conclusions:
- While differences were not statistically significant due to study limitations (underpowered, long-term survivors), results favored moderate hypothermia.
- The findings complement clinical outcomes of the TOBY Children study.
- Provides valuable long-term HRQL utility data for assessing the cost-effectiveness of hypothermic neural rescue.
Objective:
To assess the impact of hypothermic neural rescue at birth on health-related quality of life (HRQL) in middle childhood.
Design:
Six-year to 7-year follow-up of surviving children from the Total Body Hypothermia for Neonatal Encephalopathy (TOBY) Trial.
Setting:
Community study including a single parental questionnaire to collect information on children's HRQL.
Patients:
145 children (70 in the control group, 75 in the hypothermia group) whose parents consented and returned the questionnaire.
Interventions:
Intensive care with cooling of the body to 33.5°C for 72 hours or intensive care alone.
Main Outcome Measures:
HRQL attributes and utility scores using the Health Utilities Index (HUI).
Results:
At 6-7 years, speech appeared disproportionately affected when compared with other aspects of HRQL but levels of normal emotional functioning were similar in both groups. The mean (SE) HUI3 HRQL scores were 0.73 (0.05) in the hypothermia group and 0.62 (0.06) in the control group; mean difference (95% CI) 0.11 (-0.04 to 0.26).
Conclusions:
Findings of non-significant differences were not unexpected; the study used data from long-term survivors in a neonatal trial and was underpowered. However, results favoured moderate hypothermia and so complement the clinical results of the TOBY Children study. The work provides further insight into the long-term HRQL impact of perinatal asphyxial encephalopathy and provides previously unavailable utility data with which to contemplate the longer term cost-effectiveness of hypothermic neural rescue.
Trial Registration Number:
This study reports on the follow-up of the TOBY clinical trial: ClinicalTrials.gov number NCT01092637.
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