PMID- 32033793
OWN - NLM
STAT- MEDLINE
DCOM- 20200908
LR  - 20210402
IS  - 1097-6833 (Electronic)
IS  - 0022-3476 (Print)
IS  - 0022-3476 (Linking)
VI  - 219
DP  - 2020 Apr
TI  - Mortality and Neurodevelopmental Outcomes in the Heart Rate Characteristics 
      Monitoring Randomized Controlled Trial.
PG  - 48-53
LID - S0022-3476(19)31745-7 [pii]
LID - 10.1016/j.jpeds.2019.12.066 [doi]
AB  - 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.
CI  - Copyright (c) 2020 Elsevier Inc. All rights reserved.
FAU - Schelonka, Robert L
AU  - Schelonka RL
AD  - Department of Pediatrics, Division of Neonatology, Oregon Health and Science 
      University, Portland, OR. Electronic address: schelonk@ohsu.edu.
FAU - Carlo, Waldemar A
AU  - Carlo WA
AD  - Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL.
FAU - Bauer, Charles R
AU  - Bauer CR
AD  - Department of Pediatrics, University of Miami, Coral Gables, FL.
FAU - Peralta-Carcelen, Myriam
AU  - Peralta-Carcelen M
AD  - Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL.
FAU - Phillips, Vivien
AU  - Phillips V
AD  - Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL.
FAU - Helderman, Jennifer
AU  - Helderman J
AD  - Department of Pediatrics, Wake Forest School of Medicine, Winston-Salem, NC.
FAU - Navarrete, Christina T
AU  - Navarrete CT
AD  - Department of Pediatrics, Wake Forest School of Medicine, Winston-Salem, NC.
FAU - Moorman, J Randall
AU  - Moorman JR
AD  - Department of Pediatrics and Medicine, University of Virginia, Charlottesville, 
      VA.
FAU - Lake, Douglas E
AU  - Lake DE
AD  - Department of Pediatrics and Medicine, University of Virginia, Charlottesville, 
      VA.
FAU - Kattwinkel, John
AU  - Kattwinkel J
AD  - Department of Pediatrics and Medicine, University of Virginia, Charlottesville, 
      VA.
FAU - Fairchild, Karen D
AU  - Fairchild KD
AD  - Department of Pediatrics and Medicine, University of Virginia, Charlottesville, 
      VA.
FAU - O'Shea, T Michael
AU  - O'Shea TM
AD  - Department of Pediatrics, University of North Carolina, Chapel Hill, NC.
LA  - eng
GR  - R01 HD048562/HD/NICHD NIH HHS/United States
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
DEP - 20200204
PL  - United States
TA  - J Pediatr
JT  - The Journal of pediatrics
JID - 0375410
SB  - IM
MH  - Developmental Disabilities/*diagnosis
MH  - Female
MH  - *Heart Rate
MH  - Humans
MH  - Infant
MH  - Infant, Extremely Low Birth Weight
MH  - Infant, Extremely Premature
MH  - Infant, Newborn
MH  - Infant, Newborn, Diseases/*mortality
MH  - Male
MH  - Monitoring, Physiologic
MH  - Neurologic Examination
MH  - Prospective Studies
PMC - PMC7096280
MID - NIHMS1556835
OTO - NOTNLM
OT  - extremely low birthweight infant
OT  - neurodevelopmental follow up
OT  - sepsis
EDAT- 2020/02/09 06:00
MHDA- 2020/09/09 06:00
PMCR- 2021/04/01
CRDT- 2020/02/09 06:00
PHST- 2019/11/13 00:00 [received]
PHST- 2019/12/27 00:00 [revised]
PHST- 2019/12/30 00:00 [accepted]
PHST- 2020/02/09 06:00 [pubmed]
PHST- 2020/09/09 06:00 [medline]
PHST- 2020/02/09 06:00 [entrez]
PHST- 2021/04/01 00:00 [pmc-release]
AID - S0022-3476(19)31745-7 [pii]
AID - 10.1016/j.jpeds.2019.12.066 [doi]
PST - ppublish
SO  - J Pediatr. 2020 Apr;219:48-53. doi: 10.1016/j.jpeds.2019.12.066. Epub 2020 Feb 4.