Emollient therapy for hospitalised very low birth weight newborns: improving survival and health
| ISRCTN | ISRCTN15628369 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15628369 |
| Clinical Trials Registry - India (CTRI) | CTRI/2024/01/062058 |
| ICMR Proposal ID | IIRPIG-2023-0000819 |
| Sponsor | Indian Council of Medical Research |
| Funder | Indian Council of Medical Research |
- Submission date
- 31/12/2025
- Registration date
- 06/01/2026
- Last edited
- 05/01/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Neonatal Diseases
Plain English summary of protocol
Background and study aims
Neonatal deaths account for nearly half of under-five child deaths globally, with complications of preterm birth being the leading cause. Very low birth weight (VLBW) infants are particularly vulnerable due to their immature skin barrier and poses risks such as water loss, infections, and poor growth. Secondary analysis of our data from prior research in Uttar Pradesh indicates that about 1% of infants are born VLBW but these infants account for 13% of neonatal deaths. Emollient therapy that uses natural oils with beneficial fatty acid profiles, like safflower seed oil (SAO) and sunflower seed oil (SSO), has shown promise in enhancing skin barrier function, reducing infections and improving growth. While limited evidence exists on its impact on mortality (death rates), subgroup analyses from our previous study suggest significant reductions among VLBW infants receiving emollient therapy.
Addressing this gap, this study will evaluate the effect of cold-pressed SAO (chosen for its high linoleic acid content and proven anti-inflammatory and antimicrobial properties) on pre-discharge mortality in VLBW infants, contributing to global efforts to reduce neonatal mortality. We believe that available evidence sufficiently constitutes proof of principle, especially considering the well-understood mechanistic basis. However, a well-designed RCT is required to validate these findings.
The proposed multi-center study is sufficiently powered to assess the impact of emollient therapy with SAO (a skin-barrier-enhancing oil) on the survival and health outcomes of VLBW infants in SNCUs, thus addressing a critical research gap.
Who can participate?
The study will include very low birth weight infants who:
1. Weigh ≥1000 g to <1500 g upon admission to the SNCUs/ NICUs of the study facility
2. Are admitted to the SNCU or NICU of the study hospital within 24 hours of birth
3. Have mothers/ families are willing to provide consent for participation in the study
What does the study involve?
Participants are randomly allocated to the intervention group or the control group. The study involves providing infants in the intervention group with gentle application of safflower seed oil (SAO) three times daily along with routine hospital care. The oil will be applied at a dose of approximately 3 g/kg of body weight to the baby’s skin by a trained study nurse, following hand hygiene and a standardised application procedure. Infants in the control group will receive routine hospital care but will not receive oil application.
What are the possible benefits and risks of participating?
Very low birthweight (VLBW) infants who require admission in SNCU/NICU will be enrolled in this study. Since they have premature and underdeveloped skin barriers, it makes them all the more prone to infections. Emollient therapy, specifically with safflower seed oil (SAO) is known to enhance the skin barrier development and function, thereby reducing the risk of infection. Additionally, the intervention has demonstrated positive effects on infant growth, contributing to their overall physiological well-being of VLBW infants. However, participants in the control arm may not benefit from the study.
There are no major risks expected from participating in this study. There is already ample evidence supporting that emollient therapy with barrier-enhancing oils itself doesn’t pose any major risks, rather it reduces the risk of infections and has shown to improve growth in VLBW infants. Participation will not involve any extra cost. Minor risks may include severe adverse occurrences such as skin irritation, allergic reactions, minor skin rash or skin infections, severe generalised hypersensitivity reaction, phototherapy burn and hyperthermia. While the likelihood of these occurrences is very low, we will actively monitor these conditions and they will be notified to the DSMB within 24 hours of occurrence.
Both groups will continue to receive all necessary routine medical care. If any medical problem arises, appropriate treatment will be provided immediately as per hospital protocol. All information collected during the study will be kept strictly confidential.
Where is the study run from?
The study will be conducted in Sick Newborn Care Units (SNCUs) and Neonatal Intensive Care Units (NICUs) across multiple sites in India
When is the study starting and how long is it expected to run for?
September 2025 to April 2027
Who is funding the study?
Indian Council of Medical Research (ICMR) (India)
Who is the main contact?
Aarti Kumar, aarti.kumar@celworld.org
Contact information
Public
5/9, Community Empowerment Lab, Vineet Khand-5, Gomtinagar
Lucknow
226010
India
 ORCID ID |
0000-0003-1421-8775 |
|---|---|
| Phone | +91 (0)9818000252 |
| vinaypratap.singh@celworld.org |
Principal investigator, Scientific
5/9, Community Empowerment Lab, Vineet Khand-5, Gomtinagar
Lucknow
226010
India
| ORCID ID |
0000-0003-4331-3747 |
|---|---|
| Phone | +91 (0)9936060009 |
| aarti.kumar@celworld.org |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | Randomized controlled trial | |
| Masking | Open (masking not used) | |
| Control | Uncontrolled | |
| Assignment | Single | |
| Purpose | Prevention, Supportive care | |
| Scientific title | Impact of emollient therapy for hospitalised very low birth weight newborns on their survival and health outcomes - a randomised controlled trial | |
| Study acronym | EmollientVLBW | |
| Study objectives | Primary objective: 1. To assess the impact of emolliation with SAO (thrice daily application of 3 g/ kg weight) vs no emolliation on pre-discharge mortality of VLBW infants. Secondary objectives: 1. To compare clinical outcomes - neonatal mortality rate, incidence of sepsis, neonatal skin condition, and length of hospital stay in intervention vs. control groups. 2. To compare growth outcomes - mean weight gain velocity, increase in head circumference (mm/ week), and mid-upper arm circumference (MUAC), in intervention vs control groups. | |
| Ethics approval(s) |
1. Approved 12/12/2023, Institutional Ethics Committee Community Empowerment Lab, Lucknow (5/9, Community Empowerment Lab, Vineet Khand-5, Gomtinagar, Lucknow, 226010, India; +91 (0)8810725123; irb@cel.org.in), ref: CEL/RES/202412/002 2. Approved 03/12/2024, Ethics Committee GSVM Medical College Kanpur (Room No. 125, First Floor, GSVM Medical College, Kanpur, 208027, India; +91 (0)9415039582; ecgsvm@gmail.com), ref: EC/BMHR/2024/238 3. Approved 13/02/2025, IEC Sarojini Naidu Medical College Agra (Room no. 11, 1st floor, Transfusion Medicine Department, SNMC, Agra, 282002, India; +91 (0)9756966669; ecsnmc20@gmail.com), ref: SNMC/IEC/2025/15 4. Approved 17/05/2025, BHU IMS IEC (IEC BHU IMS, 3rd Floor, Aurobindo Colony, Bhelupur, Varanasi, 221005, India; +91 (0)8968577926; libraanu.99@gmail.com), ref: IMS/IEC/2025/8066 5. Approved 23/04/2025, IEC Osmania Medical College (Koti, Hyderabad, Hyderabad, 500095, India; +91 (0)40 24651936; ecomchyd@gmail.com), ref: IEC/OMC/M.NO.87(CT)-123 6. Approved 06/12/2025, IEC JSS Medical College (Sri Shivarathreeshwara Nagara, Mysuru, Karnataka, 570015, India; +91 (0)8212548345; jssmc@jssuni.edu.in), ref: JSSMC/IEC/24102025/09 NCT/2025-26 7. Submitted 17/12/2025, Institutional Ethics Committee KGMU Lucknow (Office of Ethics Committee, KGMU, Lucknow, 226003, India; +91 (0)9235237435; ethics@kgmcindia.edu), ref: 3864/ped/2025 | |
| Health condition(s) or problem(s) studied | Very low birth weight infants | |
| Intervention | 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. | |
| Intervention type | Other | |
| Primary outcome measure(s) |
| |
| Key secondary outcome measure(s) |
| |
| Completion date | 15/04/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Neonate |
| Lower age limit | 0 Days |
| Upper age limit | 27 Days |
| Sex | All |
| Target sample size at registration | 7500 |
| Total final enrolment | 2300 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 25/09/2025 |
| Date of final enrolment | 28/02/2027 |
Locations
Countries of recruitment
- India
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Editorial Notes
31/12/2025: Study's existence confirmed by the Institutional Ethics Committee Community Empowerment Lab, Lucknow.
