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Inhaled corticosteroids in transient tachypnea of the newborn: A randomized, placebo‐controlled study
Author(s) -
Vaisbourd Yulia,
AbuRaya Bahaa,
Zangen Shmuel,
Ar Shmuel,
Riskin Arieh,
Shoris Irit,
Elias Nael,
Bader David,
Kugelman Amir
Publication year - 2017
Publication title -
pediatric pulmonology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.866
H-Index - 106
eISSN - 1099-0496
pISSN - 8755-6863
DOI - 10.1002/ppul.23756
Subject(s) - medicine , tachypnea , respiratory distress , gestational age , anesthesia , placebo , randomized controlled trial , pediatrics , pregnancy , alternative medicine , pathology , biology , genetics , tachycardia
Objective Prenatal corticosteroids were shown to reduce the respiratory complication in late preterm infants. Our objective was to determine if early inhaled corticosteroids could alleviate the respiratory distress and morbidity in late preterm and term neonates with transient tachypnea of the newborn (TTN). Study Design Double‐blind, randomized placebo‐controlled, multicenter pilot study. Infants born at > 34 weeks gestational age with TTN at 4 h of age were randomized to two doses, 12 h apart, of inhaled Budesonide 1000 μg/dose or placebo within 6 h from delivery. Analysis was done by intention to treat. Results The study ( n = 24) and control ( n = 25) groups were comparable in birth characteristics (gestational age: 36.8 ± 1.9 vs 36.4 ± 1.8 weeks) and clinical condition at the time of recruitment (vital signs, clinical score, ventilation support, and blood gases). There was no difference between the study and control groups in clinical score (based on grunting, retractions, ala nasi, and respiratory rate) at recruitment and at 12, 24, and 48 h after the first inhalation (4.3 ± 1.6 vs 4.1 ± 2.1; 1.9 ± 1.8 vs 1.5 ± 1.7; 1.1 ± 1.4 vs 1.3 ± 1.6; 0.5 ± 0.8 vs 0.6 ± 1.0; respectively). Respiratory support at each time point, time to spontaneous unsupported breathing (67.4 ± 74.1 vs 75.2 ± 95.2 h), time to full feeds (86.7 ± 68.7 vs 84.3 ± 66.6 h) and length of stay (9.9 ± 5.5 vs 12.4 ± 8.0 days) did not differ between the groups. We did not detect any side effects. Conclusions Our pilot study was unable to detect a beneficial effect of early administration of inhaled steroids on the clinical course of TTN in late preterm and term infants.