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In a groundbreaking clinical trial, researchers have discovered that delaying hernia repair surgery for preterm infants until after discharge from the neonatal intensive care unit (NICU) leads to fewer adverse events compared to performing the procedure before discharge. The study, conducted across 39 US hospitals, offers critical insights into optimizing care for vulnerable preterm infants.
Methodology:
The study, which randomized 338 infants, aimed to assess the safety of hernia repair before discharge from the NICU compared to repair after discharge and post-55 weeks gestational plus chronological age (postmenstrual age). Of the 320 infants who underwent surgery, 86% were male, with 30% identified as Black and 59% as White. Primary outcomes included serious adverse events such as apnea requiring respiratory intervention, prolonged intubation, bradycardia necessitating medication, or death over a 10-month observation period. Secondary outcomes focused on hospitalization duration, encompassing initial NICU stay, postoperative hospitalization, and readmission-related inpatient days over the subsequent 10 months. Key Findings:
Infants undergoing late repair demonstrated a lower likelihood of experiencing at least one serious adverse event, with 18% in the late group compared to 28% in the early group. Moreover, infants in the late repair group experienced shorter NICU stays post-randomization and fewer hospital days following surgery. Late repair particularly benefited infants with gestational ages younger than 28 weeks and those diagnosed with bronchopulmonary dysplasia. Additionally, hernias resolved spontaneously in 11% of infants in the late repair group, indicating the potential efficacy of delaying hernia repair. Implications for Practice:
The study suggests that the timing of hernia repair, whether early or late, may not significantly impact the overall duration of NICU stays but could expedite discharge by several days if delayed repair is chosen. This finding holds particular importance for both parents and neonatologists involved in the care of preterm infants. Study Source and Limitations:
Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the study was led by Martin L. Blakely, MD, MS, from the Department of Surgery at the University of Texas Health Science Center, Houston, Texas. Despite its significant findings, the study faced limitations, including a modest sample size, a lower-than-expected randomization rate, and early discontinuation due to meeting a prespecified stopping rule for effectiveness. Disclosure:
Study authors reported various financial disclosures, including grant support from the US Department of Defense and personal fees from institutional contracts with companies such as Medicem, Fresenius Kabi, Baxter, and Mead Johnson. The study underscores the critical importance of tailored approaches in managing hernias in preterm infants, with delayed repair emerging as a promising strategy to mitigate adverse events and improve overall outcomes in this vulnerable population.
