Impact of emollient therapy for hospitalised very low birth weight newborns on their survival and health outcomes - a randomised controlled trial
Very low birth weight infants
This study is an open-label, individually randomised controlled trial. After written informed consent is obtained from the parents or caregivers for enrolment, eligible infants will be randomly allocated to either the intervention or control group. A study biostatistician has generated a computer-based randomisation sequence using random permuted blocks of variable sizes ( 2, 4 and 6), separately for each participating facility. The randomisation sequence for each site will be securely stored within the REDCap database. At the time of enrolment, once consent is confirmed, the REDCap system will automatically assign the infant to the next available allocation in the sequence. The assigned study group will be recorded in the database, without making it visible in the case report forms. As this is an open-label trial, the screening, enrolment, and intervention teams will be aware of group allocation. Infants assigned to the intervention group will be provided thrice-daily applications of SAO with a dose of about 3 g/kg body weight of SAO applied gently to the baby’s skin post-handwashing using a standardised procedure by the study nurse. The study nurse will be responsible for maintaining the quality of the application along with the quantity of SAO used, ensuring consistency and compliance with the protocol. Each session of emolliation will be logged with basic details including the time, provider, duration of emolliation, quantity of oil applied, etc. Post-discharge, the family will be supplied the study oil to enable them to continue the therapy until the age of 28 days. Infants assigned to the control group will not receive emollient therapy. All infants in both the intervention and control groups will continue to receive routine clinical care as per the existing standard of care protocols followed in the SNCU/NICU of the study facility.
All hospitalised newborns in the study facility who: 1. Weigh ≥1000 grams and <1500 grams upon admission (as per study scale) 2. Are <24 hours old at the time of admission 3. Are singletons, or in case of multiple births, the oldest infant meeting all eligibility criteria
1. Infants with generalised skin disease (these are likely to have a defect in epidermal barrier function) 2. Critically ill infants requiring Level 3 or above newborn care, including: 2.1. Requiring invasive mechanical ventilation 2.2. In shock 2.3. Severe neurological signs - Repeated seizures unresponsive to first-line antiepileptic treatment, or other signs of severe encephalopathy 3. Life-threatening congenital anomaly or a major surgical condition requiring intervention, e.g. Congenital syphilis, hydrops fetalis, or any other condition that either interferes with the provision of the intervention (e.g., severe eczema, blistering skin disorders, open wounds) or where the intervention may interfere with the provision of care (as assessed by the treating paediatrician at the time of enrolment)