Neonatal mortality rate Neonatal Diseases
Conditions
Interventions
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
Sponsors
World Health Organization (Switzerland)
Eligibility
Sex/Gender
All
Inclusion 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
Exclusion criteria: None. All babies fulfilling the inclusion criteria will be included in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 interven | — |
Countries
India
Outcome results
None listed