Trial · NCT00397150
PROMISE EBF: Safety and Efficacy of Exclusive Breastfeeding Promotion in the Era of HIV in Sub-Saharan Africa
NCT00397150, Not applicable, Completed, Centre For International Health; results first posted 2015-02-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. PROMISE EBF: Safety and Efficacy of Exclusive Breastfeeding Promotion in the Era of HIV in Sub-Saharan Africa. Trials, record NCT00397150. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00397150
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PROMISE EBF: Safety and Efficacy of Exclusive Breastfeeding Promotion in the Era of HIV in Sub-Saharan Africa
- NCT number
- NCT00397150
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 2,579 participants, actual
- Lead sponsor
- Centre For International Health
- Conditions
- Diarrhea
- Interventions
- Peer-support for exclusive breastfeeding
- First posted
- 2006-11-08
- Last updated
- 2015-02-24
- Results first posted
- 2015-02-24
- Limitations and caveats
- Trial not entirely blinded.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Exclusive Breastfeeding Rates in Burkina Faso | at 3 months of age | The EBF prevalences (24-h recall) at 12 weeks in the intervention and control clusters. |
| Primary | Infant Morbidity, 2 Week Diarrhoea Prevalence | at 3 months of age | |
| Primary | Exclusive Breastfeeding Rates in Uganda | at 3 months of age | The EBF prevalences (24-h recall) at 12 weeks in the intervention and control clusters. |
| Primary | Exclusive Breastfeeding Rates in South Africa | at 3 months of age | The EBF prevalences based on 24-h recall at 12 weeks in the intervention and control clusters. |
| Secondary | Growth | (up to 6 months of age) | |
| Secondary | Per Protocol Analysis of EBF Rates | at 3 months of age | |
| Secondary | Per Protocol Analysis of Infant Morbidity | at 3 months of age |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Exclusive Breastfeeding Rates in Burkina Faso | at 3 months of age | ITT | participants | NUMBER |
| PRIMARY | Infant Morbidity, 2 Week Diarrhoea Prevalence | at 3 months of age | participants | NUMBER | |
| SECONDARY | Growth | (up to 6 months of age) | |||
| SECONDARY | Per Protocol Analysis of EBF Rates | at 3 months of age | |||
| SECONDARY | Per Protocol Analysis of Infant Morbidity | at 3 months of age | |||
| PRIMARY | Exclusive Breastfeeding Rates in Uganda | at 3 months of age | ITT | participants | NUMBER |
| PRIMARY | Exclusive Breastfeeding Rates in South Africa | at 3 months of age | ITT | participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Exclusive Breastfeeding Rates in Burkina Faso | Intervention | 310 | participants | ||
| Exclusive Breastfeeding Rates in Burkina Faso | No Intervention | 161 | participants | ||
| Infant Morbidity, 2 Week Diarrhoea Prevalence | Intervention | 104 | participants | ||
| Infant Morbidity, 2 Week Diarrhoea Prevalence | No Intervention | 101 | participants | ||
| Exclusive Breastfeeding Rates in Uganda | Intervention | 323 | participants | ||
| Exclusive Breastfeeding Rates in Uganda | No Intervention | 161 | participants | ||
| Exclusive Breastfeeding Rates in South Africa | Intervention | 56 | participants | ||
| Exclusive Breastfeeding Rates in South Africa | No Intervention | 30 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Intervention | 1,323 | |
| Overall Study | STARTED | No Intervention | 1,256 | |
| Overall Study | COMPLETED | Intervention | 1,188 | |
| Overall Study | COMPLETED | No Intervention | 1,111 | |
| Overall Study | NOT COMPLETED | Intervention | 135 | |
| Overall Study | NOT COMPLETED | No Intervention | 145 |
Source ClinicalTrials.gov
Adverse events2
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 |
|---|---|---|---|---|---|---|
| serious | Death | Infections and infestations | Peer Counselling for Exclusive Breastfeeding | 32 | 1,323 | 32 |
| serious | Death | Infections and infestations | Standard of Care | 22 | 1,256 | 22 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Peer Counselling for Exclusive Breastfeeding | ||
| Total, all-cause mortality | Standard of Care | ||
| Total, other adverse events | Peer Counselling for Exclusive Breastfeeding | 0 | 1,323 |
| Total, other adverse events | Standard of Care | 0 | 1,256 |
| Total, serious adverse events | Peer Counselling for Exclusive Breastfeeding | 32 | 1,323 |
| Total, serious adverse events | Standard of Care | 22 | 1,256 |
Source ClinicalTrials.gov
Papers37
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Intervention vs No Intervention: Exclusive Breastfeeding Rates in Uganda | Trial comparisons |
| Intervention vs No Intervention: Infant Morbidity, 2 Week Diarrhoea Prevalence | Trial comparisons |
| Intervention vs No Intervention: Exclusive Breastfeeding Rates in South Africa | Trial comparisons |
| Intervention vs No Intervention: Exclusive Breastfeeding Rates in Burkina Faso | Trial comparisons |
| Peer Counselling for Exclusive Breastfeeding vs Standard of Care: serious adverse events | Trial comparisons |
Tests0
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00397150
GET https://conductscience.org/api/trials/v1/NCT00397150/papers?page=2