Trial Outcomes & Findings for PROMISE EBF: Safety and Efficacy of Exclusive Breastfeeding Promotion in the Era of HIV in Sub-Saharan Africa (NCT NCT00397150)
NCT ID: NCT00397150
Last Updated: 2015-02-24
Results Overview
The EBF prevalences (24-h recall) at 12 weeks in the intervention and control clusters.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
2579 participants
Primary outcome timeframe
at 3 months of age
Results posted on
2015-02-24
Participant Flow
Pregnant women are recruited in their communities.
Participant milestones
| Measure |
Intervention
Peer-counselling for exclusive breastfeeding
|
No Intervention
Standard of care
|
|---|---|---|
|
Overall Study
STARTED
|
1323
|
1256
|
|
Overall Study
COMPLETED
|
1188
|
1111
|
|
Overall Study
NOT COMPLETED
|
135
|
145
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PROMISE EBF: Safety and Efficacy of Exclusive Breastfeeding Promotion in the Era of HIV in Sub-Saharan Africa
Baseline characteristics by cohort
| Measure |
Intervention
n=1323 Participants
Peer-counselling for exclusive breastfeeding
|
No Intervention
n=1256 Participants
Standard of care
|
Total
n=2579 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1323 Participants
n=99 Participants
|
1256 Participants
n=107 Participants
|
2579 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
7 days
n=99 Participants
|
7 days
n=107 Participants
|
7 days
n=206 Participants
|
|
Sex: Female, Male
Female
|
662 Participants
n=99 Participants
|
628 Participants
n=107 Participants
|
1290 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
661 Participants
n=99 Participants
|
628 Participants
n=107 Participants
|
1289 Participants
n=206 Participants
|
|
Region of Enrollment
Burkina Faso
|
392 participants
n=99 Participants
|
402 participants
n=107 Participants
|
794 participants
n=206 Participants
|
|
Region of Enrollment
Uganda
|
396 participants
n=99 Participants
|
369 participants
n=107 Participants
|
765 participants
n=206 Participants
|
|
Region of Enrollment
South Africa
|
535 participants
n=99 Participants
|
485 participants
n=107 Participants
|
1020 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: at 3 months of agePopulation: ITT
The EBF prevalences (24-h recall) at 12 weeks in the intervention and control clusters.
Outcome measures
| Measure |
Intervention
n=392 Participants
Peer-counselling for exclusive breastfeeding
|
No Intervention
n=402 Participants
Standard of care
|
|---|---|---|
|
Exclusive Breastfeeding Rates in Burkina Faso
|
310 participants
|
161 participants
|
PRIMARY outcome
Timeframe: at 3 months of ageOutcome measures
| Measure |
Intervention
n=1323 Participants
Peer-counselling for exclusive breastfeeding
|
No Intervention
n=1256 Participants
Standard of care
|
|---|---|---|
|
Infant Morbidity, 2 Week Diarrhoea Prevalence
|
104 participants
|
101 participants
|
PRIMARY outcome
Timeframe: at 3 months of agePopulation: ITT
The EBF prevalences (24-h recall) at 12 weeks in the intervention and control clusters.
Outcome measures
| Measure |
Intervention
n=396 Participants
Peer-counselling for exclusive breastfeeding
|
No Intervention
n=369 Participants
Standard of care
|
|---|---|---|
|
Exclusive Breastfeeding Rates in Uganda
|
323 participants
|
161 participants
|
PRIMARY outcome
Timeframe: at 3 months of agePopulation: ITT
The EBF prevalences based on 24-h recall at 12 weeks in the intervention and control clusters.
Outcome measures
| Measure |
Intervention
n=535 Participants
Peer-counselling for exclusive breastfeeding
|
No Intervention
n=485 Participants
Standard of care
|
|---|---|---|
|
Exclusive Breastfeeding Rates in South Africa
|
56 participants
|
30 participants
|
SECONDARY outcome
Timeframe: (up to 6 months of age)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at 3 months of ageOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at 3 months of ageOutcome measures
Outcome data not reported
Adverse Events
Peer Counselling for Exclusive Breastfeeding
Serious events: 32 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard of Care
Serious events: 22 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Peer Counselling for Exclusive Breastfeeding
n=1323 participants at risk
|
Standard of Care
n=1256 participants at risk
|
|---|---|---|
|
Infections and infestations
Death
|
2.4%
32/1323 • Number of events 32
|
1.8%
22/1256 • Number of events 22
|
Other adverse events
Adverse event data not reported
Additional Information
Prof Thorkild Tylleskar
Centre for International Health, University of Bergen, Norway
Phone: +47 55588562
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place