Trial · NCT04598165
Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support
NCT04598165, Not applicable, Completed, Women and Infants Hospital of Rhode Island; results first posted 2024-08-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support. Trials, record NCT04598165. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04598165
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support
- NCT number
- NCT04598165
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 5,020 participants, actual
- Lead sponsor
- Women and Infants Hospital of Rhode Island
- Conditions
- Neonatal Death, Perinatal Death, Depression
- Interventions
- Interactive two-way SMS dialogue
- First posted
- 2020-10-22
- Last updated
- 2024-08-15
- Results first posted
- 2024-08-15
- Limitations and caveats
The individual rather than cluster level randomization may have led to contamination. Nurse text responses came mostly during the day and thus limited the intervention's ability to address time-sensitive concerns. Limited access to facility records also posed challenges to understanding details of clinical care. The study was not powered to find a mortality difference between the arms among babies who died after discharge from delivery hospitalization, for whom the intervention was designed.
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Neonatal Mortality | 28 days postpartum | Death during 1st 28 days of life |
| Secondary | Early Neonatal Mortality | 7 days postpartum | Death during 1st 7 days of life |
| Secondary | Initiation of Early Breastfeeding | 1 hour postpartum | Number of participants initiating breastfeeding in 1st hour of life |
| Secondary | Exclusive Breastfeeding | 6-weeks postpartum | Exclusive breastfeeding at 6-week visit |
| Secondary | Thermal Care | 24 hours postpartum | Number of participants not giving infant a bath in 1st 24 hours of life |
| Secondary | Cord Care | 2-weeks postpartum | Number of participants with no application of substances to cord |
| Secondary | Home Provision of Kangaroo Mother Care | 14 days at home postpartum | 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 |
| Secondary | Maternal Knowledge of Neonatal Danger Signs | Up to 6-weeks postpartum | Number of danger signs or symptoms successfully named |
| Secondary | Appropriate Care-seeking | 18 weeks postpartum | 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). |
| Secondary | Elevated Depressive Symptoms | Enrollment through 6-weeks postpartum | 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. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Neonatal Mortality | 28 days postpartum | Intention-to-treat for participants with a known infant outcome at 6 weeks postpartum. Seventy-two (72) participants excluded from the Overall Number of Participants Analyzed, due to stillbirth. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Early Neonatal Mortality | 7 days postpartum | Intention-to-treat for participants with a known infant outcome at the 7th day of life. Seventy-two (72) stillbirths were removed from analysis cohort. This includes 13 participants for whom an outcome is not known at 6 weeks of life for the primary outcome. Seventy-two (72) stillbirths were removed from analysis cohort.Seventy-two (72) participants excluded from the Overall Number of Participants Analyzed, due to stillbirth. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Initiation of Early Breastfeeding | 1 hour postpartum | This population includes participants who did not experience a stillbirth or infant death by 2 weeks postpartum, who attended the 2 week follow-up visit, who did not decline to answer and those for whom data was not missing. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Exclusive Breastfeeding | 6-weeks postpartum | This population includes participants who did not experience a stillbirth or infant death by 6 weeks postpartum, who attended the 6 week follow-up visit, who did not decline to answer and those for whom data was not missing. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Thermal Care | 24 hours postpartum | This population includes participants who did not experience a stillbirth or infant death by 2 weeks postpartum, whose infants did not die on the first day of life, who did not decline to answer and those for whom data was not missing. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Cord Care | 2-weeks postpartum | This population includes participants who did not experience a stillbirth or infant death by 2 weeks postpartum, those who did not decline to answer and those for whom data was not missing. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Home Provision of Kangaroo Mother Care | 14 days at home postpartum | Only among preterm and/or low birth weight live births. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Maternal Knowledge of Neonatal Danger Signs | Up to 6-weeks postpartum | For this time-varying outcome, data for the 6-week visit are presented here. This population includes those who did not decline to answer and those for whom data was not missing. Data are missing for those experienced an infant loss by the 6-week visit. | Number of danger signs named | MEDIAN |
| SECONDARY | Appropriate Care-seeking | 18 weeks postpartum | Only in infants with illness episodes with danger signs and/or where the infant was hospitalized irrespective of danger signs reported. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Elevated Depressive Symptoms | Enrollment through 6-weeks postpartum | This population includes participants who attended the 6 week visit, those who did not decline to answer and those for whom data was not missing. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Neonatal Mortality | Interactive Two-way SMS Dialogue | 46 | Participants | ||
| Neonatal Mortality | No SMS Control | 37 | Participants | ||
| Early Neonatal Mortality | Interactive Two-way SMS Dialogue | 38 | Participants | ||
| Early Neonatal Mortality | No SMS Control | 28 | Participants | ||
| Initiation of Early Breastfeeding | Interactive Two-way SMS Dialogue | 1510 | Participants | ||
| Initiation of Early Breastfeeding | No SMS Control | 1402 | Participants | ||
| Exclusive Breastfeeding | Interactive Two-way SMS Dialogue | 2190 | Participants | ||
| Exclusive Breastfeeding | No SMS Control | 2217 | Participants | ||
| Thermal Care | Interactive Two-way SMS Dialogue | 2245 | Participants | ||
| Thermal Care | No SMS Control | 2232 | Participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Completed 6-week Follow-up | STARTED | Interactive Two-way Text Messaging Dialogue | 2,509 | |
| Completed 6-week Follow-up | STARTED | No SMS Control | 2,511 | |
| Completed 6-week Follow-up | COMPLETED | Interactive Two-way Text Messaging Dialogue | 2,471 | |
| Completed 6-week Follow-up | COMPLETED | No SMS Control | 2,470 | |
| Completed 6-week Follow-up | NOT COMPLETED | Interactive Two-way Text Messaging Dialogue | 38 | |
| Completed 6-week Follow-up | NOT COMPLETED | No SMS Control | 41 | |
| Included in Intention to Treat Analysis | STARTED | Interactive Two-way Text Messaging Dialogue | 2,509 | |
| Included in Intention to Treat Analysis | STARTED | No SMS Control | 2,511 | |
| Included in Intention to Treat Analysis | COMPLETED | Interactive Two-way Text Messaging Dialogue | 2,442 | |
| Included in Intention to Treat Analysis | COMPLETED | No SMS Control | 2,442 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events14
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Social harm | Social circumstances | Interactive Two-way SMS Dialogue | 7 | 2,505 | 7 |
| other | Social harm | Social circumstances | No SMS Control | 2 | 2,508 | 4 |
| serious | Maternal death | Pregnancy, puerperium and perinatal conditions | Interactive Two-way SMS Dialogue | 2 | 2,505 | 2 |
| serious | Maternal death | Pregnancy, puerperium and perinatal conditions | No SMS Control | 2 | 2,508 | 2 |
| serious | Infant death | Pregnancy, puerperium and perinatal conditions | Interactive Two-way SMS Dialogue | 54 | 2,441 | 55 |
| serious | Infant death | Pregnancy, puerperium and perinatal conditions | No SMS Control | 39 | 2,442 | 40 |
| serious | Stillbirth | Pregnancy, puerperium and perinatal conditions | Interactive Two-way SMS Dialogue | 34 | 2,505 | 34 |
| serious | Stillbirth | Pregnancy, puerperium and perinatal conditions | No SMS Control | 39 | 2,508 | 39 |
| serious | Maternal hospitalization | General disorders | Interactive Two-way SMS Dialogue | 33 | 2,505 | 35 |
| serious | Maternal hospitalization | General disorders | No SMS Control | 11 | 2,508 | 12 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Interactive Two-way SMS Dialogue | 2 | 2,505 |
| Total, all-cause mortality | No SMS Control | 2 | 2,508 |
| Total, other adverse events | Interactive Two-way SMS Dialogue | 7 | 2,505 |
| Total, other adverse events | No SMS Control | 2 | 2,508 |
| Total, serious adverse events | Interactive Two-way SMS Dialogue | 171 | 2,505 |
| Total, serious adverse events | No SMS Control | 114 | 2,508 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01HD098105 | Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support | UNGER, JENNIFER | WOMEN AND INFANTS HOSPITAL-RHODE ISLAND | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2019 to 2023 |
Source NIH RePORTER
Trial comparisons11
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Interactive Two-way SMS Dialogue vs No SMS Control: Neonatal Mortality | Trial comparisons |
| Interactive Two-way SMS Dialogue vs No SMS Control: Early Neonatal Mortality | Trial comparisons |
| Interactive Two-way SMS Dialogue vs No SMS Control: Thermal Care | Trial comparisons |
| Interactive Two-way SMS Dialogue vs No SMS Control: Initiation of Early Breastfeeding | Trial comparisons |
| Interactive Two-way SMS Dialogue vs No SMS Control: Cord Care | Trial comparisons |
| Interactive Two-way SMS Dialogue vs No SMS Control: Elevated Depressive Symptoms | Trial comparisons |
| Interactive Two-way SMS Dialogue vs No SMS Control: Home Provision of Kangaroo Mother Care | Trial comparisons |
| Interactive Two-way SMS Dialogue vs No SMS Control: Appropriate Care-seeking | Trial comparisons |
| Interactive Two-way SMS Dialogue vs No SMS Control: deaths from any cause | Trial comparisons |
| Interactive Two-way SMS Dialogue vs No SMS Control: Exclusive Breastfeeding | Trial comparisons |
1 to 10 of 11
See all 11 trial comparisonsTests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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