Salbutamol for transient tachypnea of the newborn.
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ABSTRACT:
SUBMITTER: Moresco L
PROVIDER: S-EPMC8094231 | biostudies-literature | 2021 Feb
REPOSITORIES: biostudies-literature
Publications
Salbutamol for transient tachypnea of the newborn.
Moresco Luca L Bruschettini Matteo M Macchi Marina M Calevo Maria Grazia MG
The Cochrane database of systematic reviews 20210205
<h4>Background</h4>Transient tachypnea of the newborn is characterized by tachypnea and signs of respiratory distress. Transient tachypnea typically appears within the first two hours of life in term and late preterm newborns. Although transient tachypnea of the newborn is usually a self-limited condition, it is associated with wheezing syndromes in late childhood. The rationale for the use of salbutamol (albuterol) for transient tachypnea of the newborn is based on studies showing that β-agonis ...[more]
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| S-EPMC7164572 | biostudies-literature
Project description:Several recent studies demonstrated that lung ultrasound could achieve desired diagnostic accuracy for transient tachypnea of the neonate (TTN). However, the diagnostic performance of lung ultrasound for TTN has not been systematically studied to date. This meta-analysis aimed to investigate the performance of lung ultrasound in diagnosing TTN. The relevant literature was searched in PubMed, Medline, the Cochrane Library, and Embase databases without any restriction in terms of language and time until January 31, 2021. Studies that assessed the diagnostic performance of lung ultrasound for TTN were included. Seven studies with 1514 participants were summarized. The lung ultrasound provided more accurate performance for diagnosing TTN with pooled sensitivity and specificity of 0.67 [95% confidence interval (CI) = 0.63-0.71] and 0.97 (95% CI = 0.95-0.98), respectively. A higher summarized area under the summary receiver operating characteristic curve was observed as 0.9906. Lower sensitivity and area under the curve (AUC) of B-lines for TTN were observed as 0.330 (95% CI = 0.27-0.38) and 0.5000, respectively. Lung ultrasound provided highly accurate AUC, sensitivity, and specificity in detecting TTN. Large-scale studies are warranted in the future to confirm these results.
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Project description:BackgroundTransient tachypnea of the newborn (TTN), which results from inadequate absorption of fetal lung fluid, is the most common cause of neonatal respiratory distress. Stimulation of β-adrenergic receptors enhances alveolar fluid absorption. Therefore, the β2-adrenergic receptor agonist salbutamol has been proposed as a treatment for TTN. This study aims to evaluate the efficacy and safety of salbutamol as supportive pharmacotherapy together with non-invasive nasal continuous positive airway pressure (NIV/nCPAP) for the prevention of persistent pulmonary hypertension of the newborn (PPHN) in infants with TTN.Methods and analysisThis multicenter, double-blind, phase III trial will include infants with a gestational age between 32 and 42 weeks who are affected by respiratory disorders and treated in eight neonatal intensive care units in Poland. A total of 608 infants within 24 h after birth will be enrolled and randomly assigned (1:1) to receive nebulized salbutamol with NIV or placebo (nebulized 0.9% NaCl) with NIV. The primary outcome is the percentage of infants with TTN who develop PPHN. The secondary outcomes are the severity of respiratory distress (assessed with the modified TTN Silverman score), frequency of need for intubation, duration of NIV and hospitalization, acid-base balance (blood pH, partial pressure of O2 and CO2, and base excess), and blood serum ionogram for Na+, K+, and Ca2+.DiscussionThe Respiratory Failure with Salbutamol (REFSAL) study will be the first clinical trial to evaluate the efficacy and safety of salbutamol in the prevention of persistent pulmonary hypertension in newborns with tachypnea, and will improve short term outcomes. If successful, the study will demonstrate the feasibility of early intervention with NIV/nCPAP together with nebulized salbutamol in the management of TTN.Ethics and disseminationThe study protocol was approved by the Bioethics Committee of the Medical University of Warsaw, Warsaw, Poland on November 16, 2020 (decision number KB/190/2020). All procedures will follow the principles of the Declaration of Helsinki. The results of the study will be submitted for knowledge translation in peer-reviewed journals and presented at national and international pediatric society conferences.Clinical trial registrationIt is registered at ClinicalTrials.gov NCT05527704, EudraCT 2020-003913-36; Protocol version 5.0 from 04/01/2022.
| S-EPMC9879660 | biostudies-literature
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