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.
RCT Entities:
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.
Authors: Betty R Vohr; Bonnie E Stephens; Rosemary D Higgins; Carla M Bann; Susan R Hintz; Abhik Das; Jamie E Newman; Myriam Peralta-Carcelen; Kimberly Yolton; Anna M Dusick; Patricia W Evans; Ricki F Goldstein; Richard A Ehrenkranz; Athina Pappas; Ira Adams-Chapman; Deanne E Wilson-Costello; Charles R Bauer; Anna Bodnar; Roy J Heyne; Yvonne E Vaucher; Robert G Dillard; Michael J Acarregui; Elisabeth C McGowan; Gary J Myers; Janell Fuller Journal: J Pediatr Date: 2012-03-14 Impact factor: 4.406
Authors: Matthew A Rysavy; Lei Li; Edward F Bell; Abhik Das; Susan R Hintz; Barbara J Stoll; Betty R Vohr; Waldemar A Carlo; Seetha Shankaran; Michele C Walsh; Jon E Tyson; C Michael Cotten; P Brian Smith; Jeffrey C Murray; Tarah T Colaizy; Jane E Brumbaugh; Rosemary D Higgins Journal: N Engl J Med Date: 2015-05-07 Impact factor: 91.245
Authors: Justin C Niestroy; J Randall Moorman; Maxwell A Levinson; Sadnan Al Manir; Timothy W Clark; Karen D Fairchild; Douglas E Lake Journal: NPJ Digit Med Date: 2022-01-17
Authors: Rachael A Callcut; Yuan Xu; J Randall Moorman; Christina Tsai; Andrea Villaroman; Anamaria J Robles; Douglas E Lake; Xiao Hu; Matthew T Clark Journal: Physiol Meas Date: 2021-09-27 Impact factor: 2.688