Thermal management with and without servo-controlled system in preterm infants immediately after birth: a multicentre, randomised controlled study.
Body Temperature
/ physiology
Female
Gestational Age
Humans
Hypothermia
/ diagnosis
Incubators, Infant
Infant Care
/ instrumentation
Infant, Newborn
Infant, Premature
Infant, Premature, Diseases
/ diagnosis
Infant, Very Low Birth Weight
/ physiology
Intensive Care Units, Neonatal
Male
Outcome Assessment, Health Care
Thermometry
/ methods
Treatment Outcome
neonatology
resuscitation
Journal
Archives of disease in childhood. Fetal and neonatal edition
ISSN: 1468-2052
Titre abrégé: Arch Dis Child Fetal Neonatal Ed
Pays: England
ID NLM: 9501297
Informations de publication
Date de publication:
Nov 2021
Nov 2021
Historique:
received:
28
08
2020
revised:
29
12
2020
accepted:
31
01
2021
pubmed:
19
2
2021
medline:
27
10
2021
entrez:
18
2
2021
Statut:
ppublish
Résumé
The thermal servo-controlled systems are routinely used in neonatal intensive care units (NICUs) to accurately manage patient temperature, but their role during the immediate postnatal phase has not been previously assessed. To compare two modalities of thermal management (with and without the use of a servo-controlled system) immediately after birth. Multicentre, unblinded, randomised trial conducted 15 Italian tertiary hospitals. Infants with estimated birth weight <1500 g and/or gestational age <30 Thermal management with or without a thermal servo-controlled system during stabilisation in the delivery room. Proportion of normothermia at NICU admission (axillary temperature 36.5°C-37.5°C). At NICU admission, normothermia was achieved in 89/225 neonates (39.6%) with the thermal servo-controlled system and 95/225 neonates (42.2%) without the thermal servo-controlled system (risk ratio 0.94, 95% CI 0.75 to 1.17). Thermal servo-controlled system was associated with increased mild hypothermia (36°C-36.4°C) (risk ratio 1.48, 95% CI 1.09 to 2.01). In very low birthweight infants, thermal management with the servo-controlled system conferred no advantage in maintaining normothermia at NICU admission, while it was associated with increased mild hypothermia. Thermal management of preterm infants immediately after birth remains a challenge. NCT03844204.
Sections du résumé
BACKGROUND
BACKGROUND
The thermal servo-controlled systems are routinely used in neonatal intensive care units (NICUs) to accurately manage patient temperature, but their role during the immediate postnatal phase has not been previously assessed.
OBJECTIVE
OBJECTIVE
To compare two modalities of thermal management (with and without the use of a servo-controlled system) immediately after birth.
STUDY DESIGN AND SETTING
METHODS
Multicentre, unblinded, randomised trial conducted 15 Italian tertiary hospitals.
PARTICIPANTS
METHODS
Infants with estimated birth weight <1500 g and/or gestational age <30
INTERVENTION
METHODS
Thermal management with or without a thermal servo-controlled system during stabilisation in the delivery room.
PRIMARY OUTCOME
METHODS
Proportion of normothermia at NICU admission (axillary temperature 36.5°C-37.5°C).
RESULTS
RESULTS
At NICU admission, normothermia was achieved in 89/225 neonates (39.6%) with the thermal servo-controlled system and 95/225 neonates (42.2%) without the thermal servo-controlled system (risk ratio 0.94, 95% CI 0.75 to 1.17). Thermal servo-controlled system was associated with increased mild hypothermia (36°C-36.4°C) (risk ratio 1.48, 95% CI 1.09 to 2.01).
CONCLUSIONS
CONCLUSIONS
In very low birthweight infants, thermal management with the servo-controlled system conferred no advantage in maintaining normothermia at NICU admission, while it was associated with increased mild hypothermia. Thermal management of preterm infants immediately after birth remains a challenge.
TRIAL REGISTRATION NUMBER
BACKGROUND
NCT03844204.
Identifiants
pubmed: 33597230
pii: archdischild-2020-320567
doi: 10.1136/archdischild-2020-320567
doi:
Banques de données
ClinicalTrials.gov
['NCT03844204']
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
572-577Investigateurs
Francesco Raimondi
(F)
Petrina Bastrenta
(P)
Manuela Capozza
(M)
Silvia Del Torre
(SD)
Valentina Favero
(V)
Silvia Lama
(S)
Michele Luzzati
(M)
Concetta Marsico
(C)
Irene Sibona
(I)
Sonia Rico
(S)
Petra Wanker
(P)
Informations de copyright
© Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.