AzTrials
AzTrials

Neonatal DeathNCT04598165

Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support

A study testing Interactive two-way SMS dialogue in people with Neonatal Death and Perinatal Death, run by Women and Infants Hospital of Rhode Island at 6 sites in Kenya.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 14 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Neonatal Death, Perinatal Death, Depression
What is being tested?
Interactive two-way SMS dialogue
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5,020 participants
Where
6 sitesKenya
Study dates
7 Sep 2020to 20 Feb 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 years and older
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Currently enrolled in another research study
  • Previous participant in the Mobile WACh NEO RCT (i.e. with a new pregnancy)

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Kenya6 sites

  • Ahero Sub-District Hospital

    Ahero, Kisumu County

  • Bondo Sub-County Referral Hospital

    Bondo

  • Rachuonyo County Hospital

    Homa Bay

  • Kisumu County Hospital

    Kisumu

  • Mathare North Health Centre

    Nairobi

  • Riruta Health Center

    Nairobi

Other trials in Kenya

About this study

Official title: Mobile WACh NEO Randomized Clinical Trial: Mobile Phone 2-Way Short Message Service (SMS) Versus Control to Reduce Neonatal Mortality in Kenya

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.

Read the detailed description

High-impact essential newborn care practices and interventions are available to support neonatal survival, but coverage remains a challenge in sub-Saharan Africa, where neonatal mortality is unacceptably high. Many newborns continue to die at home without health care services being sought. The reasons are multifactorial, at the societal, health system, and family levels. Decisions made within the household and the family's ability to reach care play a large part in determining neonatal outcomes. It is estimated that up to 80% of neonatal and child deaths may have delays in recognition of infant illness and decision to seek care. Two-way mobile health (mHealth) communication strategies can enable mothers to remotely interact with a healthcare worker (HCW) and receive real-time education, counseling, encouragement, motivation and decisional guidance to support care-seeking decisions and ultimately neonatal health and survival.

The investigators developed a unique two-way SMS platform (Mobile WACh) that combines automated SMS messaging and dialogue with a HCW. The team adapted this approach for intensive neonatal support and evaluations (Mobile WACh NEO). Mobile WACh NEO (MWN) enhances the benefits of SMS messaging by engaging mothers with SMS communication and bringing timely information and support - asking critical questions at crucial times in order to assess the needs and health of newborns and assist in care seeking decisions.

This is a randomized controlled trial of the MWN intervention among 5,020 participants (2,510 MWN arm, 2,510 control arm) to determine the effect of MWN on neonatal mortality, essential newborn care, care seeking, and maternal mental health in the first 6 weeks postpartum.

Aim 1: To determine the effect of Mobile WACh NEO on neonatal mortality, compared to no SMS control.

Aim 2: To examine the effect of Mobile WACh NEO on maternal implementation of essential newborn care and care seeking behavior.

Aim 3: To examine the effects of Mobile WACh NEO on maternal social support, self-efficacy and depression.

Finally, investigators will explore the associations between maternal mental health, implementation of essential newborn care, neonatal care seeking and participant engagement by SMS.

Being tested
Interactive two-way SMS dialogue
Keywords
SMS, mHealth, neonate, mortality, depression, Kenya
Medical subject headings
Perinatal Death, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Interactive two-way SMS dialogueBehavioural

    We will utilize Mobile WACh, a human-computer hybrid system that enables seamless two-way SMS communication and patient tracking, to provide consistent support to women and their infants during the peripartum period and 6 weeks into the baby's life. Women will receive automated theoretically grounded SMS messages targeting the appropriate peripartum period and will have the capability to respond and spontaneously message a nurse based at the clinic. During pregnancy, automated SMS will be delivered weekly. Two weeks prior to the participant's estimated due date (EDD), daily messaging will begin, and will continue for two weeks after delivery is ascertained. Thereafter, SMS will be delivered every other day for the remaining four weeks. Women who experience pregnancy or infant loss will be enrolled into an infant loss track where they will receive messages of support.

Study groups in NCT04598165
Study groupRoleWhat they receive
Interactive two-way SMS dialogueExperimentalParticipants will receive automated SMS messages with prompts to reply. They will have the ability to both respond to and initiate SMS dialogue. Trained Study Nurses will monitor and respond to participant messages.
Receives: Behavioral: Interactive two-way SMS dialogue
No SMS ControlNo interventionControl receiving standard of care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neonatal Mortality

    Death during 1st 28 days of life

    Measured: 28 days postpartum

Secondary outcomes (11)

  1. Early Neonatal Mortality

    Death during 1st 7 days of life

    Measured: 7 days postpartum

  2. Initiation of Early Breastfeeding

    Number of participants initiating breastfeeding in 1st hour of life

    Measured: 1 hour postpartum

  3. Exclusive Breastfeeding

    Exclusive breastfeeding at 6-week visit

    Measured: 6-weeks postpartum

  4. Thermal Care

    Number of participants not giving infant a bath in 1st 24 hours of life

    Measured: 24 hours postpartum

  5. Cord Care

    Number of participants with no application of substances to cord

    Measured: 2-weeks postpartum

  6. Home Provision of Kangaroo Mother Care

    Number of participants providing any duration of skin-to-skin care on ≥10 of the first 14 days at home, among low birthweight or preterm infants

    Measured: 14 days at home postpartum

  7. Maternal Knowledge of Neonatal Danger Signs

    Number of danger signs or symptoms successfully named

    Measured: Up to 6-weeks postpartum

  8. Appropriate Care-seeking

    Proportion of illness episodes with danger signs in which the clinic was attended and/or where the infant was hospitalized irrespective of danger signs reported in 1st 18 weeks of life (study follow-up period).

    Measured: 18 weeks postpartum

  9. Elevated Depressive Symptoms

    Score above diagnostic threshold (>=13) for Edinburgh Postnatal Depression Scale. Possible scores are 0-30, with a higher score indicating a higher likelihood of possible depressive illness.

    Measured: Enrollment through 6-weeks postpartum

  10. Social Support

    Score using Medical Outcomes Study (MOS) Social Support Survey. Possible scores are 0-100, with a higher score indicating higher levels of social support.

    Measured: Enrollment through 6-weeks postpartum

  11. Self-efficacy

    Score using the Karitane Parenting Confidence Scale. Possible scores are 0-45, with higher scores indicating higher levels of parenting confidence.

    Measured: Enrollment through 6-weeks postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2020
  2. Study start7 Sep 2020
  3. Primary completion20 Feb 2023
  4. Study completion20 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomized to 1) Interactive two-way SMS dialogue or 2) Control (no SMS), using 1:1 allocation.
Masking
None (open label)
Enrolment
5,020 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04598165
Sponsor's protocol ID
STUDY00006395
Other IDs
1R01HD098105-01
Status last verified
Jul 2024
First submitted
2 Oct 2020
Last updated
15 Aug 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data from Mobile WACh NEO will be available at end of the project by contacting the study team at the University of Washington (neor01@uw.edu).

Publications

  • Ronen K, Choo EM, Wandika B, Udren JI, Osborn L, Kithao P, Hedstrom AB, Masinde M, Kumar M, Wamalwa DC, Richardson BA, Kinuthia J, Unger JA. Evaluation of a two-way SMS messaging strategy to reduce neonatal mortality: rationale, design and methods of the Mobile WACh NEO randomised controlled trial in Kenya. BMJ Open. 2021 Dec 23;11(12):e056062. doi: 10.1136/bmjopen-2021-056062.

    PubMed 34949631

  • Unger JA, Kinuthia J, Wandika B, Hedstrom A, Wetzler E, Udren JI, Masinde M, Choo EM, Schultes O, Kithao P, Moraa J, Akinyi E, Osborn L, Nzove E, Richardson BA, Kumar M, Wamalwa D, Ronen K. The impact of interactive text communication on neonatal mortality in Kenya: a randomized controlled trial. Nat Med. 2025 Jun;31(6):1847-1854. doi: 10.1038/s41591-025-03576-z. Epub 2025 Mar 12.

    PubMed 40075230

Questions about this trial

What is this clinical trial studying?

A study testing Interactive two-way SMS dialogue in people with Neonatal Death and Perinatal Death, run by Women and Infants Hospital of Rhode Island at 6 sites in Kenya.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neonatal Mortality (time frame: 28 days postpartum). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04598165, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in