Time to Reaching Target Cooling Temperature and 2-year Outcomes in Infants with Hypoxic-Ischemic Encephalopathy
Copyright © 2023 Elsevier Inc. All rights reserved..
OBJECTIVE: To determine if time to reaching target temperature (TT) is associated with death or neurodevelopmental impairment (NDI) at 2 years of age in infants with hypoxic-ischemic encephalopathy (HIE).
STUDY DESIGN: Newborn infants ≥36 weeks of gestation diagnosed with moderate or severe HIE and treated with therapeutic hypothermia were stratified based on time at which TT was reached, defined as early (ie, ≤4 hours of age) or late (>4 hours of age). Primary outcomes were death or NDI. Secondary outcomes included neurodevelopmental assessment with Bayley Scales of Infant and Toddler Development, third edition (BSID-III) at age 2.
RESULTS: Among 500 infants, the median time to reaching TT was 4.3 hours (IWR, 3.2-5.7 hours). Infants in early TT group (n = 211 [42%]) compared with the late TT group (n = 289 [58%]) were more likely to be inborn (23% vs 13%; P < .001) and have severe HIE (28% vs 19%; P = .03). The early and late TT groups did not differ in the primary outcome of death or any NDI (adjusted RR, 1.05; 95% CI, 0.85-0.30; P = .62). Among survivors, neurodevelopmental outcomes did not differ significantly in the 2 groups (adjusted mean difference in Bayley Scales of Infant Development-III scores: cognitive, -2.8 [95% CI, -6.1 to 0.5], language -3.3 [95% CI, -7.4 to 0.8], and motor -3.5 [95% CI, -7.3 to 0.3]).
CONCLUSIONS: In infants with HIE, time to reach TT is not independently associated with risk of death or NDI at age 2 years. Among survivors, developmental outcomes are similar between those who reached TT at <4 and ≥4 hours of age.
TRIAL REGISTRATION: High-dose Erythropoietin for Asphyxia and Encephalopathy (HEAL); NCT02811263; https://beta.
CLINICALTRIALS: gov/study/NCT02811263.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2024 |
|---|---|
| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:266 |
|---|---|
| Enthalten in: |
The Journal of pediatrics - 266(2024) vom: 01. März, Seite 113853 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Rao, Rakesh [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Age at target temperature |
|---|
| Anmerkungen: |
Date Completed 26.02.2024 Date Revised 08.03.2024 published: Print-Electronic ClinicalTrials.gov: NCT02811263 Citation Status MEDLINE |
|---|
| doi: |
10.1016/j.jpeds.2023.113853 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM364981830 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM364981830 | ||
| 003 | DE-627 | ||
| 005 | 20240308232202.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2024 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1016/j.jpeds.2023.113853 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1320.xml |
| 035 | |a (DE-627)NLM364981830 | ||
| 035 | |a (NLM)38006967 | ||
| 035 | |a (PII)S0022-3476(23)00717-5 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Rao, Rakesh |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Time to Reaching Target Cooling Temperature and 2-year Outcomes in Infants with Hypoxic-Ischemic Encephalopathy |
| 264 | 1 | |c 2024 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 26.02.2024 | ||
| 500 | |a Date Revised 08.03.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT02811263 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2023 Elsevier Inc. All rights reserved. | ||
| 520 | |a OBJECTIVE: To determine if time to reaching target temperature (TT) is associated with death or neurodevelopmental impairment (NDI) at 2 years of age in infants with hypoxic-ischemic encephalopathy (HIE) | ||
| 520 | |a STUDY DESIGN: Newborn infants ≥36 weeks of gestation diagnosed with moderate or severe HIE and treated with therapeutic hypothermia were stratified based on time at which TT was reached, defined as early (ie, ≤4 hours of age) or late (>4 hours of age). Primary outcomes were death or NDI. Secondary outcomes included neurodevelopmental assessment with Bayley Scales of Infant and Toddler Development, third edition (BSID-III) at age 2 | ||
| 520 | |a RESULTS: Among 500 infants, the median time to reaching TT was 4.3 hours (IWR, 3.2-5.7 hours). Infants in early TT group (n = 211 [42%]) compared with the late TT group (n = 289 [58%]) were more likely to be inborn (23% vs 13%; P < .001) and have severe HIE (28% vs 19%; P = .03). The early and late TT groups did not differ in the primary outcome of death or any NDI (adjusted RR, 1.05; 95% CI, 0.85-0.30; P = .62). Among survivors, neurodevelopmental outcomes did not differ significantly in the 2 groups (adjusted mean difference in Bayley Scales of Infant Development-III scores: cognitive, -2.8 [95% CI, -6.1 to 0.5], language -3.3 [95% CI, -7.4 to 0.8], and motor -3.5 [95% CI, -7.3 to 0.3]) | ||
| 520 | |a CONCLUSIONS: In infants with HIE, time to reach TT is not independently associated with risk of death or NDI at age 2 years. Among survivors, developmental outcomes are similar between those who reached TT at <4 and ≥4 hours of age | ||
| 520 | |a TRIAL REGISTRATION: High-dose Erythropoietin for Asphyxia and Encephalopathy (HEAL); NCT02811263; https://beta | ||
| 520 | |a CLINICALTRIALS: gov/study/NCT02811263 | ||
| 650 | 4 | |a Clinical Trial | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a age at target temperature | |
| 650 | 4 | |a hypoxia-ischemia | |
| 650 | 4 | |a neonatal encephalopathy | |
| 700 | 1 | |a Comstock, Bryan A |e verfasserin |4 aut | |
| 700 | 1 | |a Wu, Tai-Wei |e verfasserin |4 aut | |
| 700 | 1 | |a Mietzsch, Ulrike |e verfasserin |4 aut | |
| 700 | 1 | |a Mayock, Dennis E |e verfasserin |4 aut | |
| 700 | 1 | |a Gonzalez, Fernando F |e verfasserin |4 aut | |
| 700 | 1 | |a Wood, Thomas R |e verfasserin |4 aut | |
| 700 | 1 | |a Heagerty, Patrick J |e verfasserin |4 aut | |
| 700 | 1 | |a Juul, Sandra E |e verfasserin |4 aut | |
| 700 | 1 | |a Wu, Yvonne W |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t The Journal of pediatrics |d 1945 |g 266(2024) vom: 01. März, Seite 113853 |w (DE-627)NLM000019003 |x 1097-6833 |7 nnns |
| 773 | 1 | 8 | |g volume:266 |g year:2024 |g day:01 |g month:03 |g pages:113853 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1016/j.jpeds.2023.113853 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 266 |j 2024 |b 01 |c 03 |h 113853 | ||