Emollient Therapy for Premature Infants in Zimbabwe

Launched by STANFORD UNIVERSITY · Jul 13, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how applying moisturizing treatments, called emollients, to premature infants can help them grow better and reduce the chances of dying. The goal is to see if these treatments can improve the health of very low birth weight babies, who are particularly vulnerable. The trial is set to take place in Zimbabwe and is not yet recruiting participants.

To be eligible for this study, infants must be less than 72 hours old and weigh between 700 and 1500 grams (about 1.5 to 3.3 pounds) at birth, and they need to be receiving care at a specific hospital. However, some babies won't be able to participate, such as those who are very ill or have severe skin conditions. If your baby meets the criteria to join, they will receive the emollient treatment along with the usual care provided in the hospital. This trial aims to find out if this simple addition to their care can make a significant difference in their health outcomes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • infants \<72 hours of age
• • weigh 700-1500 at birth
• • hospitalized at SMCH
• Exclusion Criteria:
• • infants who are moribund and highly likely not to survive despite any intervention
• • significant breaches in their skin barrier
• • conditions indicating failure to gain weight
• * critically ill (definition below):
• 1. Oxygen saturation \<88% on oxygen therapy AND ≥2 of the following conditions:
• • 2. respiratory rate \<20 or \>100 breaths per minute
• • 3. apnea requiring bag-mask ventilation
• • 4. heart rate \<100 or \>200 beats per minute
• • congenital syphilis
• • hydrops fetalis
• • a life-threatening congenital anomaly or major surgical condition requiring intervention
• • generalized skin disease or a structural defect involving \>5% body surface area likely to produce a defect in epidermal barrier function