Can an intervention involving improvements in community-based newborn massage practice with promotion of cold-pressed sunflower oil as preferred emollient improve newborn survival in rural North India?

• Register: ISRCTN
• Last refreshed on: 17 January 2022
• Main ID: ISRCTN38965585
• Date of registration: 30/07/2014
• Prospective Registration: Yes
• Primary sponsor: World Health Organization (Switzerland)
• Public title: Can an intervention involving improvements in community-based newborn massage practice with promotion of cold-pressed sunflower oil as preferred emollient improve newborn survival in rural North India?
• Scientific title: Impact of topical application of cold-pressed sunflower seed oil with improved massage practices on neonatal mortality: a cluster randomized controlled trial in rural North India
• Date of first enrolment: 01/01/2015
• Target sample size: 41072
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN38965585
• Study type: Interventional
• Study design: Single-center cluster randomized controlled trial. (Prevention)
• Phase: Not Applicable

Countries of recruitment

India

Contacts

• Name: Vishwajeet Kumar

Key inclusion & exclusion criteria

Inclusion criteria:
All newborns (or neonatal deaths) identified in the study area till 7 days of delivery irrespective of place of delivery will be considered as eligible for analysis of trial outcomes. The inclusion criteria would be met in the community, in the following conditions:
1. Mother stays through the antenatal period and delivers in the study village
2. Mother delivers outside the study village (e.g., maternal home or health facility) but returns to the study village within the first 7 days of delivery
3. In case of maternal deaths, newborns identified in the study villages within 7 days of delivery
Thus, all women/babies who are found to be residing in a particular cluster at the time of first identification during the first 7 days of delivery will be analyzed as part of the same cluster, irrespective of migration or place of delivery, as per principles of intention to treat.

Exclusion criteria: None. All babies fulfilling the inclusion criteria will be included in the study.

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Neonatal mortality rate
Neonatal Diseases

Intervention(s)

The technical intervention essentially consists of:
1. The product, i.e. cold-pressed sunflower seed oil
2. Directions for newborn massage. The ?directions for newborn massage? further consist of the following aspects:
2.1. Dosage of SSO, comprising of frequency of use, quantity per use, and duration of use.
2.1.1. Dose: 10g per application, applied 3x daily
2.1.2. Duration: 0-27 days of life
2.2. Improvements in overall massage practice:
2.2.1. Encourage hand washing prior to massage
2.2.2. Encourage gently massaging the vernix into the newborn skin, rather than forcefully removing it
2.2.3. Promote gentle massage of newborns
2.2.4. Delay use of mustard oil and skin-scrubbing substances such as bukwa (coarse-grained paste made of mustard/wheat seeds along with additives) past the newborn period
2.2.5. Ensure that the newborn is kept warm during and after massage

Pregnant women who intend to deliver in the intervention area and consent to participate in the trial would be oriented to the intervention and provided an initial supply of oil at 24-27 weeks of gestation, in order to ensure early application on preterm newborns. After birth, oil supply will be replenished on a regular basis by logistics officers. All traditional massage providers (called ?nauns?) providing services in the intervention area would be trained in improved massage practice, and will be expected to train mothers and care providers in the recommended practice.

No such intervention will be introduced in the control group, which will continue following the same traditional massa

Primary Outcome(s)

1. NMR post-24 hours of birth or the number of neonatal deaths that occur after 24 hours of birth, per 1000 live births.
2. Neonatal mortality rate (NMR) or the number of neonatal deaths per 1000 live births.

Secondary Outcome(s)

1.Infections and hospitalization: Signs and symptoms of infection during the newborn period, along with episodes of hospitalization would be recorded through parent recall. These will include local infections such as pyoderma and umbilical cord infection.
2. Growth: Weight of the baby as close as possible to birth (Day 0) and on Day 28, would be measured through standardized infant weighing scales and procedures.
3. Mechanisms: Mechanistic studies will be conducted on a random sub-sample (5%) of babies from both arms on days 1, 3 and 7. These include studies to understand the biological effects of the intervention on newborn skin. The aim of studying mechanisms is also to attempt to find potential markers that may be used to test the protective effect of oils alone. The parameters that would be included are:
3.1. Videography of massage to document variations in practice
3.2. Skin barrier function: Barrier property of Stratum Corneum (assessed as trans-epidermal water loss or TEWL)
3.3. Neonatal skin scoring using an appropriate scale (for example, the scale used by Association of Women's Health, Obstetric and Neonatal Nurses (AWHONN), or the Neonatal Skin Risk Assessment Scale for predicting skin breakdown in newborns).
3.4. We will also explore the use of high resolution imaging techniques to assess skin condition.
4. Dose ? response: Any relationship between the exclusive application of provided oil, and the duration and frequency of massage practiced by the family, and the morbidity and mortality outcomes will be assessed.
5. Intervention coverage: We will measure the percentage of mothers/ families that were reached through the intervention delivery strategy, received the intervention through an accredited Naun and received sufficient oil supplies.
6. Changes in practices: We expect the neonatal mortality in the intervention arm to be reduced through changes in practices related to newborn skin care, massage and oil use. Therefore changes in these practices is an important process outcome of the study. We will also measure other key newborn care practices including care-seeking, which are not hypothesized to be different between the intervention and control arms.
7. Adherence to Intervention: Information on continued oil use and adherence to massage technique would be obtained from families (mothers). This would also be applicable to a sub sample (5%) of the population.

Secondary ID(s)

WHO Reference No.: RPC667 The Universal Trial Number (UTN): U1111-1158-4665

Source(s) of Monetary Support

World Health Organization (WHO) Geneva (Switzerland), Bill & Melinda Gates Foundation (USA)

Ethics review

Status:
Approval date:
Contact:

1.Community Empowerment Lab Institutional Ethics Committee (CEL IEC), 07/06/2014, ref. CELIEC/2014001 2. World Health Organization Research Ethics Review Committee (WHO ERC), 12/06/2014, ref RPC667

Results

• Results available: Yes
• Date Completed: 31/12/2016