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Published on: April 29, 2013
Mortality and Neurodevelopmental Outcomes in the Heart Rate Characteristics Monitoring Randomized Controlled Trial
Robert L Schelonka1, Waldemar A Carlo2, Charles R Bauer3
1Department of Pediatrics, Division of Neonatology, Oregon Health and Science University, Portland, OR.
Insights
Continuous monitoring of heart rate characteristics in neonatal intensive care did not reduce the composite outcome of death or neurodevelopmental impairment (NDI) in extremely preterm infants. However, mortality was significantly reduced in the monitored group.
Area of Science:
- Neonatal Medicine
- Pediatric Neurology
- Clinical Trials
Background:
- Extremely preterm infants face high risks of mortality and neurodevelopmental impairment (NDI).
- Continuous monitoring of heart rate characteristics is a potential intervention to improve outcomes in the neonatal intensive care unit (NICU).
Purpose of the Study:
- To evaluate the effect of continuous heart rate characteristics monitoring on the composite outcome of death or NDI in infants weighing ≤1000g at birth.
- To determine if this monitoring strategy impacts mortality and specific neurodevelopmental outcomes.
Main Methods:
- A subset of infants from a multicenter randomized trial were analyzed.
- Survivors were assessed at 18-22 months corrected age using neurologic examinations and the Bayley Scales of Infant Development-III (BSID-III).
- Neurodevelopmental impairment (NDI) was defined by criteria including cerebral palsy, cognitive/language scores, hearing, and vision impairment.
Main Results:
- The composite outcome of death or NDI did not differ significantly between the monitored group (38.9%) and controls (44.4%).
- However, mortality was significantly reduced in the group with displayed heart rate characteristics monitoring (24.8% vs. 32.0% in controls, P=0.028).
- Composite outcomes of death or severe cerebral palsy, and death or low Bayley cognitive score were less frequent in the monitored group.
Conclusions:
- Continuous heart rate characteristics monitoring did not significantly decrease the composite outcome of death or NDI in extremely preterm infants.
- The intervention showed a significant reduction in mortality and certain components of NDI, suggesting a potential benefit for specific adverse outcomes.
Objective:
To test whether the composite outcome of death or neurodevelopmental impairment (NDI) at 18-22 months corrected age for infants ≤1000 g at birth is decreased by continuous monitoring of heart rate characteristics during neonatal intensive care.
Study Design:
We studied a subset of participants enrolled in a multicenter randomized trial of heart rate characteristics monitoring. Survivors were evaluated at 18-22 months corrected age with a standardized neurologic examination and the Bayley Scales of Infant Development-III (BSID-III). NDI was defined as Gross Motor Function Classification System of >2 (moderate or severe cerebral palsy), BSID-III language or cognitive scores of <70, severe bilateral hearing impairment, and/or bilateral blindness.
Results:
The composite outcome, death or NDI, was obtained for 628 of 884 study infants (72%). The prevalence of this outcome was 44.4% (136/306) among controls (infants randomized to heart rate characteristics monitored but not displayed) and 38.9% (125/322) among infants randomized to heart rate characteristics monitoring displayed (relative risk, 0.87; 95% CI, 0.73-1.05; P = .17). Mortality was reduced from 32.0% (99/307) among controls to 24.8% (81/326) among monitoring displayed infants (relative risk, 0.75; 95% CI, 0.59 to 0.97; P = .028). The composite outcomes of death or severe CP and death or mildly low Bayley cognitive score occurred less frequently in the displayed group (P < .05).
Conclusions:
We found no difference in the composite outcome of death or NDI for extremely preterm infants whose heart rate characteristics were and were not displayed during neonatal intensive care. Two outcomes that included mortality or a specific NDI were less frequent in the displayed group.
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