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?

Completed

Conditions: Newborn Sepsis, Prematurity, Newborn skin care, Newborn massage, Neonatal mortality rate reduction, community-based newborn care

Registration Number: CTRI/2014/12/005282

Lead Sponsor: Department of Maternal Newborn Child and Adolescent Health World Health Organization

Brief Summary: Serious infections and complications of preterm birth together contribute to almost 60% of newborn deaths worldwide. The human skin is a very important organ and serves as an important barrier to infection. The skin barrier of the newborn, and especially preterm babies has fewer layers and is not fully functionally mature. However, communities across the north Indian belt, Nepal and Bangladesh have several practices that may further compromise the skin barrier and expose newborns to a higher risk of infection. These include forceful removal of the vernix (a protective greasy substance that covers the babyâ€™s skin when born) often with coarse substances that can further abrade the skin, regular massage of babies with flour/ mustard seed paste (which can be abrasive to newborn skin) from the first day itself, massaging with mustard oil which is known to delay skin barrier recovery, putting oil into body orifices, etc. The proposed intervention consists of promoting cold-pressed sunflower seed oil sunflower seed oil, that has been shown to improve skin condition, accelerate recovery of the skin barrier function and reduce the risk of infections and death among hospitalized newborns in low-resource settings, for massage of newborns, alongwith improved and hygienic massaging practices. The aim of the study is to assess the impact of topical application of cold-pressed SSO with improved massage practices, as compared to standard community-based massage practices, on neonatal mortality.

The study has been designed as a public health efficacy trial, and will be evaluated using a 2-arm cluster randomized controlled design in 276 contiguous villages (clusters) in rural Uttar Pradesh, India. All the newborns identified in the study area within 7 days of delivery will be included in the study. For the purpose of enrollment, pregnant women will be identified within 24 weeks of gestation, and prospectively followed until 28 days of delivery. The study will enroll approximately 42,000 newborns over a period of 24 months, beginning January 2015.

In the intervention arm, we will train women who traditionally massage newborns during the first 10-12 days of life (called nauns) in the improved and hygienic massage technique. Cold-pressed sunflower oil will be distributed to all mothers in the intervention arm with instructions on its application to newborn babies. The nauns are also expected to train mothers and families in the improved massage technique. No such intervention will be introduced in the control group, which will continue following the same traditional massage practices.

The study will track vital events (pregnancies, births, newborn deaths) in the entire study area through a prospective follow-up of all mothers until 28 days of delivery and measure other key outcomes. Newborn deaths in the intervention and control groups will be statistically compared, along with changes in practices and other key outcome indicators to evaluate the impact of the intervention.

*Risks & potential benefits*: The activities in the intervention arm are expected to cause no harm to babies and may potentially reduce the incidence of newborn infections and deaths. Sunflower oil is a natural oil that is safe for massage and has been used previously in hospital based studies. Mothers and caregivers will be trained by nauns (community masseuses) in the practice of improved and hygienic massage that will mitigate risk to the newbornâ€™s skin barrier function. There is no additional risk to infants in the control arm, who will continue to receive traditional newborn massage as practiced by families. The evaluation procedures are standard, and include measuring parameters such as weight and temperature of the baby. Mothers will be asked detailed questionnaires regarding massage practices, other newborn care practices, illnesses, care-seeking, etc. These involve minimal risk to participants.

The study is supported by the World Health Organization, Geneva, through a grant from the Bill & Melinda Gates Foundation. The primary contact for the study is the Principal Investigator, Dr. Vishwajeet Kumar ([vishwajeet.kumar@cel.org.in](mailto:vishwajeet.kumar@cel.org.in)).

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 41072

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

All babies fulfilling the inclusion criteria will be included in the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.NMR post-24 hours of birth or the number of neonatal deaths that occur after 24 hours of birth, per 1000 live births.	Day 1 and Day 28
2.Neonatal mortality rate (NMR) or the number of neonatal deaths per 1000 live births	Day 1 and Day 28

Secondary Outcome Measures

Name	Time	Method
1.Infections and hospitalization	2.Growth of the newborn

Trial Locations

Locations (1): Shivgarh
🇮🇳
Bareli, UTTAR PRADESH, India
Shivgarh
🇮🇳Bareli, UTTAR PRADESH, India
Dr Vishwajeet Kumar
Principal investigator
vishwajeet.kumar@shivgarh.org