To evaluate the safety and clinical benefit of NexoBrid in hospitalized children (0-18 years) with thermal burns of 1-30% total body surface area as compared to standard of care. Patients enrolled in this trial will undergo daily assessments in hospital after their treatment until they are discharged. They will then have weekly follow-ups until completed wound closure. Once this is achieved, there will be a 6 week, 12 week, 6 month, 12 month, 18 month, and 24 month follow up visit.
The Hernia in Premies (HIP) Trial is a multi-site randomized clinical trial that is comparing two accepted treatment choices, surgery before or after neonatal intensive care unit (NICU) discharge, for inguinal hernia (IH) repair in premature infants. The reason we are doing this study is that surgeons and neonatologists currently do not know the best time to perform the hernia repair. Some providers recommend having the hernia fixed before discharge from the neonatal intensive care unit (NICU) and some believe waiting until after NICU discharge is better. Both treatments are standard options for IH repair in premature infants. Also, all babies that have IH repair receive anesthesia. We also do not know if the age of the child receiving anesthesia affects neurodevelopment. We are comparing the timing of anesthesia exposure between the two treatments (IH repair before or after NICU discharge) to help answer these questions.
By volunteering to take part in the HIP Trial, your child will be randomly assigned to have the operation before or after NICU discharge. This means that the timing of the repair operation will be determined by chance, like flipping a coin, and he/she has an equal chance of being treated before or after NICU discharge. We will be collecting information about your baby and the treatment that he or she receives, and how your baby recovers before and after the surgery. We will also collect information about your baby from clinic notes and results from your baby's routine 2 year follow-up neurodevelopmental testing, where your child will be asked questions that measure cognitive, language, social and motor development. We will stop collecting information about your baby and your participation will end when your child is 2 years old. There are no extra medical tests or blood work being done for research purposes in the HIP trial.