Background
Most neonatal deaths can be averted by existing interventions that prevent and treat neonatal illness. The “three delays framework” identifies 3 critical delays in accessing care: 1) identifying illness and the decision to seek care, 2) reaching an appropriate facility, and 3) receiving adequate care. The first delay occurs beyond the reach of the clinic and is estimated to account for up to 80% of neonatal deaths. A critical gap exists in supporting caregivers, typically mothers, to implement essential newborn care practices (ENC) at home, identify neonatal illness when it occurs, and seek timely clinic-based care. A mother’s ability and decision to practice ENC and seek care is influenced by several factors, including her knowledge, as well as, critically, her own mental health, social support and self-efficacy.
We developed an interactive short message service (SMS) platform, Mobile WACh, that connects women with information and support from a nurse (Unger 2018, Harrington 2019, Perrier 2015).
Mobile WACh Neo (MWN) is tailored for the neonatal period and engages mothers by SMS to bring timely information and support – asking critical questions at crucial times in order to assess the needs and health of newborns. Our overarching goal is to determine the effect of MWN on neonatal mortality and understand the mechanisms by which this innovation impacts neonatal health.
Figure 1 : Conceptual framework for Mobile WACh NEO
Aims
Our overarching aim is to determine the effect of Mobile WACh Neo on neonatal mortality and understand the mechanisms by which this innovation impacts neonatal health. We propose to determine the effect of MWN on neonatal mortality, ENC, care seeking, and maternal mental health in the first 6 weeks postpartum, in a 2-armed randomized controlled trial (RCT), comparing MWN SMS versus no SMS control. Our specific aims are:
Aim 1: To determine the effect of tailored, systematic two-way MWN SMS on neonatal mortality.
Hypothesis: Women randomized to MWN will have lower neonatal mortality than women randomized to control.
Aim 2: To determine the effect of MWN SMS on maternal implementation of ENC and care seeking behavior.
2a. To compare practices of early and exclusive breastfeeding, cord care and thermal care among mothers randomized to MWN versus control.
2b. To compare knowledge of infant danger signs and care seeking for neonatal illness among mothers randomized to MWN versus control. Hypothesis: Implementation of ENC, knowledge of neonatal danger signs, and clinic attendance will be higher in mothers randomized to MWN than control.
Aim 3: To determine the effect of MWN SMS on longitudinal maternal social support, self-efficacy and depression among mothers randomized to MWN versus control.
Hypothesis: Maternal self-efficacy and social support will be higher and depression will be lower among women randomized to MWN than control.
Exploratory aim: To determine associations between maternal mental health, implementation of ENC, care seeking and SMS engagement.
Design
Our team is conducting an unblinded randomized controlled trial among 5000 women (2500 MWN arm, 2500 control arm) to determine the effect of our intervention on neonatal mortality, essential newborn care, care seeking, and maternal mental health in the first 6 weeks postpartum. The primary outcome of the trial will be neonatal mortality, defined as death within the first 28 days of life.
Participants are recruited from 4 public maternal child health (MCH) clinics in Nairobi and Western Kenya. Eligible participants are age ≥14, pregnant at gestational age 28-36 weeks, have daily access to a mobile phone (their own or shared), can read or write or have access to a trusted person who can help them read and write, and plan to stay in the study area for 5 months postpartum.
All clinical care will be managed through the existing MCH infrastructure. The study visit schedule will be aligned to routine postpartum and infant visits, starting with enrollment in late pregnancy. SMS intervention participants will receive actionable messages throughout pregnancy and up to 6 weeks postpartum that provide education and support for infant care based on clinical guidelines. A trained study nurse responds to routine questions and triages any health concerns raised by participants, referring to local facilities for care as needed. MWN women and families will have a companion throughout the journey of birth and the neonatal period. We will evaluate this novel intervention, which has potential to address a crucial gap in supporting mothers to care for their neonates and seek care when needed, making a significant contribution to the World Health Organization’s Every Newborn Action Plan to end preventable neonatal death and stillbirth.
Figure 2: CONSORT diagram of Mobile WACh NEO Trial. ANC: antenatal care