Use of palivizumab in infants and young children with severe respiratory disease: a Delphi study

Abstract

Objective: To achieve a consensus of opinion among an expert group of pediatric pulmonologists regarding the appropriateness of the off-label use of palivizumab for some pediatric patients with severe respiratory diseases.

Methods: A two-round modified Delphi technique was used. A 43-item self-administered questionnaire grouped into seven clinical scenarios was developed. Level of agreement for each statement was ranked on a 0-9 scale with 0 being total disagreement and 9 total agreement. Consensus was sought through the feedback of information and iteration. The final responses were evaluated for median and interquartile range to determine which questions the group had reached consensus about, either affirmatively or negatively.

Results: Consensus was obtained for 24/43 statements (55.81%), including use of palivizumab for prevention of respiratory syncytial virus (RSV) infection in children with severe respiratory involvement due to neuromuscular disease, congenital or acquired immunodeficiency, storage disease, cystic fibrosis, diseases involving impaired ciliary clearance, patients operated on esophageal atresia and/or tracheoesophageal fistula, diaphragmatic hernia, bronchopulmonary malformations, severe tracheomalacia, lung transplant recipients and patients in the waiting list for lung transplant, patients oxygen-dependent for severe interstitial pulmonary disease and patients with severe pulmonary hypertension. Consensus against the use of palivizumab as prevention of RSV infection was also achieved in almost all the recurrent wheezing/asthma attacks situations.

Conclusion: A set of indication for off-label uses of palivizumab in pediatric pulmonology was developed in accordance with the degree of professional consensus on which they were based. The applicability of the present results to clinical practice should be evaluated individually and reviewed periodically in the light of new emerging evidence. Further studies are needed to add evidence to the most frequent and clinically oriented scenarios that have shown higher levels of uncertainty.

Keywords: infant; prophylaxis; respiratory syncytial virus infection; young children.