Health Condition 1: P070- Extremely low birth weight newborn Health Condition 2: P072- Extreme immaturity of newborn
Conditions
Interventions
Intervention1: Intervention Group: SAO Emolliation: Infants assigned to the intervention group will be provided thrice-daily applications of SAO with a dose of about 3g/kg body weight of SAO applied g
Sponsors
Indian Council of Medical Research (ICMR)
Community Empowerment Lab
Eligibility
Inclusion criteria
Inclusion criteria: All hospitalised newborns in the study facility who: • weighing more than or equal to 1000 grams and less than 1500 grams upon admission (as per study scale) • Are less than 24 hours old at the time of admission • Are singletons, or in case of multiple births, the oldest infant meeting all eligibility criteria • Whose mothers or families are willing to provide consent for participation in the study
Exclusion criteria
Exclusion criteria: Infants with generalised skin disease (these are likely to have a defect in epidermal barrier function) Critically ill infants requiring Level 3 or above newborn care, including: o Requiring invasive mechanical ventilation o In shock o Severe neurological signs - Repeated seizures unresponsive to first-line antiepileptic treatment, or other signs of severe encephalopathy • 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pre-discharge mortality rateTimepoint: Follow-up until discharge of the newborn period (28 days of age). Infants leaving against medical advice or transferred to another facility for care will be excluded from the analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical OutcomesTimepoint: a) Neonatal mortality rate Timepoint: Follow-up on the 28th day of age b) Incidence of suspected sepsis Timepoint: Daily follow-up until discharge or 28 days of age, whichever is earlier c) Skin condition scores Timepoint: At the time of enrolment, with subsequent measures at age 3, 7, 14, & 28 days, or at the time of discharge, whichever is earlier d) Duration of hospital stay Time Point: At the time of discharge;Growth OutcomesTimepoint: a) Weight gain velocity Time Point: Daily weighing until discharge or 28 days of age, whichever is earlier b) Head circumference growth velocity Time Point: At admission, day 14, & at discharge or on day 28, whichever is earlier c) Mid Upper Arm Circumference (MUAC) growth velocity Time Point: At admission, day 14, & on day 28 or at discharge, whichever is earlier | — |
Countries
India
Contacts
Public ContactMr Vinay Pratap Singh
Community Empowerment Lab
Outcome results
None listed