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. 2002 Jan;7(1):13-9.
doi: 10.1093/pch/7.1.13.

Early prophylactic inhaled beclomethasone in infants less than 1250 g for the prevention of chronic lung disease

K A Jangaard  1 , D A Stinson, A C Allen, M J Vincer
Affiliations

Early prophylactic inhaled beclomethasone in infants less than 1250 g for the prevention of chronic lung disease

K A Jangaard et al. Paediatr Child Health. 2002 Jan.

Abstract
in English, French

Objective: Inflammation plays an important role in the development of chronic lung disease (CLD), which has become a major cause of morbidity in surviving infants less than 1250 g at birth. The authors hypothesized that the progression of this inflammation and, therefore, the establishment of CLD would be decreased with the use of early prophylactic inhaled corticosteroids. Short, and long term respiratory and neurodevelopmental outcomes were also examined.

Design: A double-blind, randomized placebo controlled trial.

Setting: Level-III neonatal intensive care unit.

Population studied: Sixty infants less than 1250 g at birth, diagnosed with respiratory distress syndrome and requiring ventilatory support at 72 h of age were enrolled in the study.

Intervention: Infants enrolled received either placebo or beclomethasone diproprionate by a metered dose inhaler, which was used in-line with the ventilator circuit while the infant was ventilated and then via a spacer until 28 days of age.

Results: Thirty infants were given beclomethasone and 30 were given placebo. There were two deaths in each group. Among the surviving infants, the frequency of moderate-to-severe CLD was 17% in each study group. Mean time to extubation was not different for beclomethasone compared with placebo at 16.4 and 12.5 days (P=0.12), respectively. The requirement for intravenous corticosteroids was lower in the beclomethasone-treated group (RR 0.67, 95% CI 0.43 to 1.04), although this difference was not statistically significant. The incidence of growth failure, infection and intraventricular hemmorhage did not differ between the two groups. Long term outcomes were not different with respect to the incidence of respiratory re-admissions, cerebral palsy, developmental delay, blindness or deafness.

Conclusions: Early treatment with inhaled beclomethasone diproprionate did not reduce the incidence of CLD or decrease the duration of mechanical ventilation. The decrease in intravenous corticosteroid use was not statistically significant. Long term outcome was not affected.

OBJECTIF :: L’inflammation joue un rôle important dans l’évolution d’une affection pulmonaire chronique (APC), qui constitue désormais une cause importante de morbidité chez les nourrissons survivants de moins de 1 250 g à la naissance. Les auteurs ont émis l’hypothèse que la progression de cette inflammation et, par conséquent, l’établissement d’une APC, diminuerait grâce à une prophylaxie précoce de corticoïdes par inhalation. Les issues respiratoires et neurodéveloppementales à court et à long terme ont également été examinées.

MÉTHODOLOGIE :: Essai aléatoire à double insu, contrôlé contre placebo.

LIEU :: Unité de soins intensifs néonatals de niveau III.

POPULATION À L’ÉTUDE :: Ont participé à l’étude soixante nourrissons de moins de 1 250 g à la naissance, souffrant d’un syndrome de détresse respiratoire démontré et ayant besoin d’un soutien ventilatoire à 72 h de vie.

INTERVENTION :: Les nourrissons ont reçu soit un placebo, soit du dipropionate de béclométhasone par inhalateur doseur, utilisé directement avec le circuit ventilatoire lorsque les nourrissons étaient sous ventilation, puis au moyen d’une aérochambre jusqu’à l’âge de 28 jours.

RÉSULTATS :: Trente nourrissons ont reçu du béclométhasone et les trente autres, un placebo. Deux décès ont été constatés dans chacun des deux groupes. Parmi les nourrissons survivants, la fréquence d’APC moyenne à grave s’établissait à 17 % dans chaque groupe. Le temps moyen avant l’extubation était comparable entre le groupe sous béclométhasone et celui sous placebo, soit respectivement 16,4 jours et 12,5 jours (P = 0,12). Le besoin de corticoïdes par voie intraveineuse était inférieur au sein du groupe sous béclométhasone (RR 0,67, IC 95 %, 0,43 à 1,04), bien que cette différence ne soit pas statistiquement significative. L’incidence de stagnation staturale, d’infection et d’hémorragie intraventriculaire ne variait pas entre les deux groupes. Les issues à long terme ne différaient pas pour ce qui est de l’incidence de réhospitalisations secondaires à des troubles respiratoires, de paralysie cérébrale, de retard de développement, de cécité ou de surdité.

CONCLUSIONS :: Un traitement précoce au dipropionate de béclométhasone par inhalation ne réduit pas l’incidence d’APC ou la durée de la ventilation mécanique. L’administration réduite de corticoïdes par voie intraveineuse n’est pas statistiquement significative. L’issue à long terme ne change pas.

Keywords: Chronic lung disease; Clinical trial; Growth delay; Inhaled corticosteroid; Long term neurodevelopmental follow-up; Randomized control trial.

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Figures

Figure 1)
Figure 1)
Details of patient recruitment. Sixty-seven patients were eligible to participate in the study, and 60 patients enrolled. Patients were not enrolled for the following reasons: three children’s parents refused to enroll their child, one infant was deemed unlikely to survive by the attending neonatologist, the parents of two infants were not available for consent and one infant was missed because the prinicipal investigator (PI) was absent
See this image and copyright information in PMC

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