N/A
N=5,020
Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support
Neonatal Death · Perinatal Death · Depression
Bottom Line
View on ClinicalTrials.gov: NCT04598165 ↗Enrolled (actual)
5,020
Serious AEs
5.7%
Results posted
Aug 2024
Primary outcome: Primary: Neonatal Mortality — 46; 37 Participants — p=0.314
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Interactive two-way SMS dialogue (Behavioral)
- Age
- Pediatric, Adult, Older Adult · 14+ yrs
- Sex
- Female
- Sponsor
- Women and Infants Hospital of Rhode Island
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Neonatal Mortality |
46; 37 | 0.314 |
| SECONDARY Early Neonatal Mortality |
38; 28 | 0.217 |
| SECONDARY Initiation of Early Breastfeeding |
1510; 1402 | 0.064 |
| SECONDARY Exclusive Breastfeeding |
2190; 2217 | 0.363 |
| SECONDARY Thermal Care |
2245; 2232 | 0.093 |
| SECONDARY Cord Care |
1123; 1104 | 0.353 |
| SECONDARY Home Provision of Kangaroo Mother Care |
12; 10 | 0.751 |
| SECONDARY Maternal Knowledge of Neonatal Danger Signs |
3; 2 | 0.431 |
| SECONDARY Appropriate Care-seeking |
204; 160 | 0.321 |
| SECONDARY Elevated Depressive Symptoms |
38; 40 | 0.650 |
| SECONDARY Social Support |
84.2; 84.2 | 0.071 |
| SECONDARY Self-efficacy |
45; 45 | 0.190 |
Summary
To improve neonatal mortality, it is critical to engage families, especially mothers, in essential newborn care (ENC) and appropriate care-seeking for neonatal illness as well as to support maternal mental health and self-efficacy. This randomized controlled trial (RCT) aims to determine the effect and mechanisms of a two- way mobile health (mHealth) SMS intervention, Mobile WACh NEO, on neonatal mortality, essential newborn practices, care-seeking and maternal mental health at four sites in Kenya.
Eligibility Criteria
Inclusion Criteria
- Pregnant
- 28-36 weeks gestation
- Daily access to a mobile phone (own or shared) on the Safaricom network
- Willing to receive SMS
- Able to read and respond to text messages in English, Kiswahili or Luo, or have someone in the household who can help
Exclusion Criteria
- Currently enrolled in another research study
- Previous participant in the Mobile WACh NEO RCT (i.e. with a new pregnancy)
Data sourced from ClinicalTrials.gov (NCT04598165). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.