The Effect of Inhaled Budesonide on the Prevention of Chronic Lung Disease in Premature Neonates with Respiratory Distress Syndrome
Abstract
Background: Considering all the latest achievements in neonatal respiratory care, bronchopulmonary dysplasia (BPD) is still among the most prevalent morbidity causes in premature infants. Involvement in this process results in longer period of hospitalization for the newborn and in the long run makes the living conditions more diffcult. Taking the multifactorial pathogenesis into account, approaches to tackle chronic lung disease (CLD) are mainly focused on interventions and prevention procedures. This study tries to investigate the potential capability of inhaled budesonide in the prevention of BPD in newborns with gestational age of <28 weeks with the respiratory distress syndrome (RDS).
Methods: This study was a randomized clinical trial done on seventy
newborns with gestational ages of 23–28 weeks with RDS in Isfahan Shahid Beheshti Educational Hospital from June 2014 to April 2016. Patients were randomly assigned to two groups of intervention with budesonide and control. There were 35 newborns in each group. Upon recording demographic characteristics, the newborns in two groups were compared based on the length of noninvasive ventilation, the need for invasive mechanical ventilation, the number of surfactant administrations, pneumothorax, intraventricular hemorrhage, patent ductus arteriosus (PDA), CLD, and death.
Results: The length of the need for nasal continuous positive airway pressure showed no statistically signifcant difference between the groups (P = 0.54). The number of newborns who needed invasive mechanical ventilation also revealed no meaningful difference (P = 0.14). Similarly,
the number of newborns who were characterized as affected by CLD also showed no signifcant difference between the groups (P = 0.053). Moreover, the number of newborns who experienced pneumothorax was not signifcantly different for the groups (P = 0.057). The number of newborns
who received three administrations of surfactant had also no statistically meaningful difference between the groups (P = 0.69). However, the number of newborns who received two doses of surfactant was statistically lower in budesonide intervention group than the control (P = 0.041).
The prevalence of intraventricular hemorrhage with degrees of I, II, and III also showed no statistically meaningful difference between the groups with P = 0.74, 0.32, and 0.49, respectively. The occurrence of PDA had no meaningful difference between the groups (P = 0.66). Relative death cases also revealed no signifcant difference between the groups (P = 0.53).
Conclusions: The current study revealed a decrease in CLD prevalence for newborns in interventional group; however, this decrease was not statistically meaningful. The newborns, in the intervention group,
who had received two doses of surfactant (survanta) showed a signifcant decrease, which can be the basis for further research in this feld.
Keywords: Budesonide, chronic lung disease, respiratory distress syndrome
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Trembath A, Laughon MM. Predictors of bronchopulmonary
dysplasia. Clin Perinatol 2012;39:585‑601.
O’Reilly M, Thébaud B. Cell‑based strategies to reconstitute
lung function in infants with severe bronchopulmonary dysplasia.
Clin Perinatol 2012;39:703‑25.
Tin W, Wiswell TE. Drug therapies in bronchopulmonary
dysplasia: Debunking the myths. Semin Fetal Neonatal Med
;14:383‑90.
Shou‑Yien W, Tessy J, Medha K, Suma P, Tsu‑Fuh Y. Postnatal
corticosteroid to prevent or treat chronic lung disease in preterm
infants. Neonatol Today 2009;4:1.
Tropea K, Christou H. Current pharmacologic approaches for
preventation and treatment of bronchopulmonary. Int J Pediatr
;1:1.
Schmidt B, Roberts RS, Davis P, Doyle LW, Barrington KJ,
Ohlsson A, et al. Long term effects of caffeine therapy for apnea
of prematurity. N Engl J Med 2006;354:2112‑21.
Kao LC, Durand DJ, McCrea RC, Birch M, Powers RJ,
Nickerson BG. Randomized trial of long‑term diuretic therapy
for infants with oxygen‑dependent bronchopulmonary dysplasia.
J Pediatr 1994;124:772‑81.
Brion LP, Primhak RA, Ambrosio‑Perez I. Diuretics acting on the
distal renal tubule for preterm infants with (or developing) chronic
lung disease. Cochrane Database Syst Rev 2002;1:CD001817.
Denjean A, Paris‑Llado J, Zupan V, Debillon T, Kieffer F,
Magny JF, et al. Inhaled salbutamol and beclomethasone
for preventing broncho‑pulmonary dysplasia: A randomised
double‑blind study. Eur J Pediatr 1998;157:926‑31.
Viscardi RM, Hasday JD, Gumpper KF, Taciak V, Campbell AB,
Palmer TW. Cromolyn sodium prophylaxis inhibits pulmonary
proinflammatory cytokines in infants at high risk for
bronchopulmonary dysplasia. Am J Respir Crit Care Med
;156:1523‑9.
Darlow BA, Graham PJ. Vitamin A supplementation to
prevent mortality and short and long‑term morbidity in
very low birthweight infants. Cochrane Database Syst Rev
;4:CD000501.
Howlett A, Ohlsson A. Inositol for respiratory distress syndrome in
preterm infants. Cochrane Database Syst Rev 2000;4:CD000366.
Mamo LB, Suliman HB, Giles BL, Auten RL, Piantadosi CA,
Nozik‑Grayck E. Discordant extracellular superoxide dismutase
expression and activity in neonatal hyperoxic lung. Am J Respir
Crit Care Med 2004;170:313‑8.
Sandberg K, Fellman V, Stigson L, Thiringer K, Hjalmarson O.
N‑acetylcysteine administration during the first week of life does
not improve lung function in extremely low birth weight infants.
Biol Neonate 2004;86:275‑9.
Berger TM, Frei B, Rifai N, Avery ME, Suh J, Yoder BA,
et al. Early high dose antioxidant vitamins do not prevent bronchopulmonary dysplasia in premature baboons exposed to
prolonged hyperoxia: A pilot study. Pediatr Res 1998;43:719‑26.
Ballard RA, Truog WE, Cnaan A, Martin RJ, Ballard PL,
Merrill JD, et al. Inhaled nitric oxide in preterm infants
undergoing mechanical ventilation. N Engl J Med
;355:343‑53.
Bancalari E. Corticosteroids and neonatal chronic lung disease.
Eur J Pediatr 1998;157 Suppl 1:S31‑7.
D’Angio CT, Maniscalco WM. Bronchopulmonary dysplasia in
preterm infants: Pathophysiology and management strategies.
Paediatr Drugs 2004;6:303‑30.
Bassler D, Halliday HL, Plavka R, Hallman M, Shinwell ES,
Jarreau PH, et al. The neonatal European study of inhaled
steroids (NEUROSIS): An eu‑funded international randomised
controlled trial in preterm infants. Neonatology 2010;97:52‑5.
Shah VS, Ohlsson A, Halliday HL, Dunn M. Early administration
of inhaled corticosteroids for preventing chronic lung disease in
ventilated very low birth weight preterm neonates. Cochrane
Database Syst Rev 2012;5:CD001969.
Kattwinkel J. Textbook of Neonatal Resuscitation. 6th ed. AAP;
p. 274‑6.
Fuchs H, Schilleman K, Hummler HD, Tepas AB. Techniques
and devices to improve noninvasive ventilation in the delivery
room. Neoreviews 2012;13:355‑7.
Kahn DJ, Habib RH, Courtney SE. Effects of flow amplitudes on
intraprong pressures during bubble versus ventilator‑generated
nasal continuous positive airway pressure in premature infants.
Pediatrics 2008;122:1009‑13.
Stevens TP, Harrington EW, Blennow M, Soll RF. Early
surfactant administration with brief ventilation vs. selective
surfactant and continued mechanical ventilation for preterm
infants with or at risk for respiratory distress syndrome.
Cochrane Database Syst Rev 2007;4:CD003063.
Kribs A, Pillekamp F, Hünseler C, Vierzig A, Roth B. Early
administration of surfactant in spontaneous breathing with
nCPAP: Feasibility and outcome in extremely premature
infants (postmenstrual age =27 weeks). Paediatr Anaesth
;17:364‑9.
Mazela J, Polin RA. Aerosol delivery to ventilated newborn
infants: Historical challenges and new directions. Eur J Pediatr
;170:433‑44.
Mazzella M, Bellini C, Calevo MG, Campone F, Massocco D,
Mezzano P, et al. A randomised control study comparing the
Infant Flow Driver with nasal continuous positive airway
pressure in preterm infants. Arch Dis Child Fetal Neonatal Ed
;85:F86‑90.
Rojas MA, Lozano JM, Rojas MX, Laughon M, Bose CL,
Rondon MA, et al. Very early surfactant without mandatory
ventilation in premature infants treated with early continuous
positive airway pressure: A randomized, controlled trial.
Pediatrics 2009;123:137‑42.
Vento G, Matassa PG, Zecca E, Tortorolo L, Martelli M, De
Carolis MP, et al. Effect of dexamethasone on tracheobronchial
aspirate fluid cytology and pulmonary mechanics in preterm
infants. Pharmacology 2004;71:113‑9.
Soll RF. Current trials in the treatment of respiratory failure in
preterm infants. Neonatology 2009;95:368‑72.
Cole CH, Colton T, Shah BL, Abbasi S, MacKinnon BL,
Demissie S, et al. Early inhaled glucocorticoid therapy to prevent
bronchopulmonary dysplasia. N Engl J Med 1999;340:1005‑1.
Jónsson B, Eriksson M, Söder O, Broberger U, Lagercrantz H.
Budesonide delivered by dosimetric jet nebulization to preterm
very low birthweight infants at high risk for development of
chronic lung disease. Acta Paediatr 2000;89:1449‑55.
Jangaard KA, Stinson DA, Allen AC, Vincer MJ. Early
prophylactic inhaled beclomethasone in infants less than 1250 g
for the prevention of chronic lung disease. Paediatr Child Health
;7:13‑9.