Procedure for unblinding if needed {17b}
seizures
ADVERSE EVENT
Infants will exit the study intervention without unblinding (but remain in the trial) if they have not weaned off study drug by 35 days from the first weaning dose. This represents more than twice the median and mean length of treatment for the morphine arm in the Davis et al. trial. This will avoid prolongation of treatment and length of hospital stay due to inability to tolerate the intervention guideline. To exit the Intervention one of the following criteria would need to be meet:A participant cannot ingest anything by mouth and needs intravenous opioid due to an increase in acuity or need of an operative procedure.Participant who has a serious adverse event, including seizures, increased respiratory support, intravenous fluid for increased stool output, or unable to take enteral medication.Parents or legal guardians wish to withdraw their infant from the intervention.The clinical team feels it is in the best interest of the infant to be withdrawn from the intervention.If an infant meets one of the above criteria for exiting the intervention without unmasking, the following actions should be taken:The clinical team responsible for the daily management of the infant will consult with the site research team. The site research team will verify that the circumstance for exiting the study intervention is appropriate by checking the Manual of Operations. Once verified, the site research team will communicate with the clinical team and the pharmacy that the infant will exit the study intervention. The pharmacy will provide the clinical team of what the opioid dose would have been in each arm of the trial.