Impact of emollient therapy for very low birth weight infants in Special Newborn Care Units on infant survival, health, and maternal mental health outcomes- A randomised controlled trial - SSO VLBW

Indian Council of Medical Research (ICMR)0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年3月4日

试验速览

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•The study will enrol singleton infants categorized as very low birthweight infants i.e., weighing more than 1000 grams and less than or equal to 1500 grams with no critical illness upon admission to the SNCUs or NICUs of the study facility within 24 hours of birth and whose mothers or families are willing to provide consent for participation in the study.

•1. Critically ill infants. We define critical illness as: oxygen saturation less than 88% on oxygen therapy plus two or more criteria below:
•- respiratory rate less than 20 or greater than 100 breaths per minute,
•- apnea requiring bag-mask ventilation, or
•- heart rate less than 100 or greater than 200 beats per minute.
•2. Life-threatening congenital anomaly or a major surgical condition requiring intervention, congenital syphilis, hydrops fetalis, generalised skin disease, any other condition deemed suitable for exclusion by treating paediatrician.
•3. Mothers exhibit complications that may hinder their ability to provide emolliation
•4. Written informed consent from mother or caregivers could not be obtained.

发起方

Indian Council of Medical Research (ICMR)