A phase II/III, randomized, open-label, clinical trial to evaluate the safety and efficacy of emollient therapy for very low birthweight infants (<1500g) in Uganda in promoting survival, health, growth and development compared to no emollient treatment.

Mbale Clinical Research Institute0 个研究点目标入组 1,242 人开始时间: 2024年4月29日最近更新: 2024年5月27日

试验速览

暂无简介。

•Admission weight 800g to <1500g
•Admission age < 24 hours
•Mother +/- father who can understand English, Luganda, Lugwere, Ateso or Lumasaba
•Mother +/- father who are willing and able to give written informed consent for participation of their infant in the study.
•Mother aged 15 years or above

•Mother or father are not willing or are unable to give written, informed consent for participation of their infant in the study within 48 hours of admission to the NNU
•Second or later birth order or a multiple pregnancy, when the first or an earlier birth order infant is eligible for participation
•Infants with major congenital abnormality e.g. gastroschisis, cyanotic heart disease, upper airways abnormality
•Critically ill infants at time of enrollment: Babies with apnoeas requiring frequent stimulation or bag mask ventilation; shock (heart rate >200 beats per minute and/or Mean Arterial Pressure •Infants with generalized skin disease or a structural defect involving >5% body surface area likely to produce a defect in epidermal barrier function.
•Mother and father unwilling to come back to Mbale RRH for follow-up

发起方

Mbale Clinical Research Institute