Vitality in Infants Via Azithromycin for Neonates Trial

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · Feb 28, 2023

Keywords

ClinConnect Summary

The Vitality in Infants Via Azithromycin for Neonates Trial is studying whether a medication called azithromycin can help improve the health of newborns who are either low birthweight or underweight. Many babies who are born with low weight face serious health risks, including higher chances of death and growth issues. This trial will give eligible babies, aged 1 to 27 days old, a single dose of azithromycin, two doses of azithromycin spaced apart, or two doses of a placebo (a non-active substance) to see if it helps them gain weight and fight infections better. The main goal is to compare the weight of the babies at six months to see if azithromycin makes a difference.

To be eligible for this trial, the baby needs to be between 1 and 27 days old, have a birthweight of less than 2,500 grams (about 5.5 pounds), or have specific weight issues. The family must plan to stay in the study area for at least six months and agree to participate. Throughout the study, caregivers will be informed about what to expect, and regular check-ups will be scheduled to monitor the baby's progress. The findings from this trial could provide important information on how to support the health of vulnerable newborns effectively.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Aged 1-27 days old
• • Birthweight \< 2500 g and/or weight-for-height Z score \<- 2 standard deviations at enrollment
• • Weigh at least \<1500 g at time of enrollment
• • Able to feed orally
• • Family intends to stay in the study area for at least 6 months
• • Appropriate consent from at least one caregiver
• • No known allergy to macrolides
• • No hepatic failure manifested by neonatal jaundice
• • Not currently an inpatient at the clinic
• • Not being transferred to a hospital for clinical complications
• Exclusion Criteria:
• • Birthweight \> 2500 g
• • Weigh less than 1500 g at time of enrollment
• • Unable to feed orally
• • Family planning to move within 6 months
• • Mother/ caregiver not willing to participate
• • Allergic to macrolides
• • Hepatic failure manifested by neonatal jaundice
• • Currently being seen as an inpatient at the clinic
• • Currently being transferred to a hospital for clinical complications