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Emollient therapy for hospitalised very low birth weight newborns: improving survival and health

Impact of emollient therapy for hospitalised very low birth weight newborns on their survival and health outcomes - a randomised controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15628369
Enrollment
7500
Registered
2026-01-06
Start date
2025-09-25
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Very low birth weight infants Neonatal Diseases

Interventions

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 alloca

Sponsors

Indian Council of Medical Research
Lead Sponsor

Eligibility

Sex/Gender
All
Age
0 Days to 27 Days

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion 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)

Countries

India

Contacts

Public ContactVinay Pratap Singh
vinaypratap.singh@celworld.org+91 (0)9818000252

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026