Clinical Research Directory

Short-Term Enteral Nutrition for Infants With Bronchiolitis in Pediatric Emergency Departments

Sponsor: Hospices Civils de Lyon

Summary

Bronchiolitis is a common viral infection of the small airways that affects infants, particularly during respiratory syncytial virus epidemics. Some infants mainly develop feeding difficulties, with a marked reduction in milk intake or refusal to feed, while showing no immediate signs of severe respiratory impairment. These infants often need nutritional support through a nasogastric tube, which is a small tube passed through the nose into the stomach. Under usual care, starting enteral nutrition generally requires admission to a pediatric short-stay unit or a conventional inpatient ward. The purpose of this study is to determine whether a short period of enteral nutrition provided directly in the pediatric emergency department can reduce the total number of days spent in hospital during the 14 days following inclusion, compared with usual inpatient care. The short-term pathway is called the Short-Term Enteral Nutrition Protocol in the Pediatric Emergency Room (STENP-PER). The study will include 448 infants treated in eight pediatric emergency departments in France. Eligible infants will be between 8 completed weeks of corrected age and 11 months and 30 days of chronological age. They must have bronchiolitis, have had respiratory symptoms for at least 72 hours, and require nutritional support because their feeding has fallen below half of the usual amount during the previous 12 hours or because they refuse to feed. Infants with signs of severe respiratory, neurological, or nutritional illness, important medical risk factors, or circumstances that would make discharge or follow-up unsafe will not be included. This is a cluster-randomized stepped-wedge study. This means that the pediatric emergency departments, rather than individual infants, will be randomly assigned to the order in which they introduce the STENP-PER pathway. All participating departments will initially provide usual inpatient care. They will then progressively switch to the new pathway over four annual respiratory syncytial virus epidemic seasons. Each department will therefore contribute information during both a usual-care period and an intervention period. During the usual-care period, infants will be admitted to a pediatric short-stay unit or conventional inpatient ward for enteral nutrition and clinical monitoring, according to the usual procedures of each hospital. During the STENP-PER period, trained emergency department staff will place a nasogastric tube and provide continuous enteral nutrition for six hours while monitoring the infant's general condition, breathing, vital signs, and any adverse events. A parent will remain with the infant whenever possible. Parents will receive practical education, including information and instruction on nasal clearance. After six hours, the infant will be reassessed by the clinical team. If the infant's condition allows it, the infant will return home. If hospital monitoring or treatment is still needed, the infant will be admitted according to usual care. Participation in the study will not prevent clinicians from changing or stopping the feeding procedure when this is considered necessary for the infant's safety. The infant's health and use of healthcare services will be followed from inclusion through Day 14. Information will be obtained from hospital records and through a telephone call with the parents around Day 14. The main outcome is the total number of days spent in hospital during this period. This includes an immediate hospital stay after the first emergency department visit and any later hospitalization or rehospitalization related to the same episode of bronchiolitis or its management. The study will also compare the percentage of infants admitted immediately, the percentage transferred to another hospital, parents' satisfaction and experience of care, parents' understanding of advice about bronchiolitis, healthcare professionals' satisfaction, and the number and type of adverse events. The investigators will also examine how well the pathway is introduced and followed in each emergency department, how acceptable it is to families and healthcare professionals, the barriers and factors supporting its use, and whether it can be maintained and transferred to other hospitals. Interviews with parents and group discussions with healthcare professionals will provide additional information about their experience. Finally, a health-economic evaluation will compare the costs of the two care strategies over 14 days. The study is expected to show whether providing short-term enteral nutrition in the pediatric emergency department is a safe and effective alternative to systematic hospital admission for carefully selected infants with bronchiolitis and predominant feeding difficulties.

Official title: Evaluation of Short-Term Enteral Nutrition in Pediatric Emergency Departments for Young Infants With Bronchiolitis and Predominant Nutritional Impairment

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