Tolerability of Enteral NAC in Infants

Launched by SANJIV HARPAVAT · Feb 7, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a potential new treatment for biliary atresia, a liver condition that affects infants and often requires surgery to help restore bile flow. The researchers want to see if an oral medication called N-acetylcysteine (NAC) is safe and well-tolerated when given to infants with this condition. They will check if the babies can handle taking this medication without vomiting, and they will also look at how the infants react to the taste of NAC compared to other medicines they might already be taking.

To participate in the study, infants need to be between 122 and 273 days old and have a confirmed diagnosis of biliary atresia. They should be able to eat and take medications by mouth, and they will need to stay in the hospital for at least four days. Parents or guardians will need to give their consent after being informed about the study. It's important to note that infants with certain health issues, such as severe liver disease or those currently in the neonatal intensive care unit, will not be eligible for this trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 122-273 days of life at time of enrollment
• • Confirmed diagnosis of biliary atresia based on intraoperative cholangiogram
• • Able to tolerate oral nutrition and medications and not on continuous tube feeds
• • Anticipated inpatient admission of at least 4 days
• • Legal guardian(s) consent to study enrollment after understanding the risks and investigational nature of the study
• Exclusion Criteria:
• • Gestational age of \<32 weeks at birth
• • Inability or contraindication to taking oral nutrition
• • Neonatal intensive care unit admission
• • Short bowel, or other malabsorptive, syndrome
• • Decompensated liver disease (INR \> 1.3 despite vitamin K administration)
• • Active respiratory infection
• • Severe concurrent illnesses that would interfere with the conduct and/or results of the study
• • Concurrent participation in another drug trial