Trial Outcomes & Findings for Low-birthweight Infant Feeding Exploration (NCT NCT04002908)
NCT ID: NCT04002908
Last Updated: 2025-04-27
Results Overview
A Child's length-for-age z-score at 6 months of age. Length-for-age z-scores (LAZ) are based on World Health Organization (WHO) child growth standards for term infants and INTERGROWTH-21st standards were used for preterm infants. A LAZ Z-score of 0 represents the population mean and scores below 0 represent a worse outcome. Further, Z-scores less than -2.0 indicates stunting in the infant.
Recruitment status
COMPLETED
Target enrollment
3188 participants
Primary outcome timeframe
At 6 month of age
Results posted on
2025-04-27
Participant Flow
The LIFE study did not involve an intervention. Enrollment of the prospective cohort was of mother-infant dyads; we have reported baseline data of the respective individuals. Outcome measurement is at the infant level. Similarly, for the in-facility observation cohort, we have reported baseline characteristics of individuals (mothers and infants); however, the outcomes are focused on infants. Thus, we have reported outcomes at that level.
Unit of analysis: facilities
Participant milestones
| Measure |
Prospective Cohort Study - Quantitative
Mothers and their low-birth weight babies will be enrolled 72 hours after birth and followed through 12 months postpartum. The prospective cohort survey (which includes anthropometric measurements and feeding observations) occurs at multiple time points over this 12-month period.
|
In-facility Observations
Moderately low birthweight infants (1500 to \<2500g) and their mothers (i.e. dyads) were enrolled for observation while in the post-natal ward or neonatal intensive care unit.
|
Prospective Cohort Study - Qualitative
Qualitative interviews: Focus Group Discussions (FGDs) were conducted with mothers, family members, and community leaders; In-depth interviews (IDIs) were completed with Health care providers, government officials, and supply chain and donor human milk experts
|
LIFE Study: Retrospective Chart Review & Donor Human Milk Readiness Assessment
Medical records of moderately low birthweight infants from 12 months before study initiation were reviewed from facilities involved in the LIFE study. Additionally, a Donor Human Milk Readiness Assessment was conducted at each of the participating facilities.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
2184 12
|
290 12
|
355 12
|
359 12
|
|
Overall Study
COMPLETED
|
1925 12
|
290 12
|
355 12
|
359 12
|
|
Overall Study
NOT COMPLETED
|
259 0
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
| Measure |
Prospective Cohort Study - Quantitative
Mothers and their low-birth weight babies will be enrolled 72 hours after birth and followed through 12 months postpartum. The prospective cohort survey (which includes anthropometric measurements and feeding observations) occurs at multiple time points over this 12-month period.
|
In-facility Observations
Moderately low birthweight infants (1500 to \<2500g) and their mothers (i.e. dyads) were enrolled for observation while in the post-natal ward or neonatal intensive care unit.
|
Prospective Cohort Study - Qualitative
Qualitative interviews: Focus Group Discussions (FGDs) were conducted with mothers, family members, and community leaders; In-depth interviews (IDIs) were completed with Health care providers, government officials, and supply chain and donor human milk experts
|
LIFE Study: Retrospective Chart Review & Donor Human Milk Readiness Assessment
Medical records of moderately low birthweight infants from 12 months before study initiation were reviewed from facilities involved in the LIFE study. Additionally, a Donor Human Milk Readiness Assessment was conducted at each of the participating facilities.
|
|---|---|---|---|---|
|
Overall Study
Death
|
41
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
112
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
72
|
0
|
0
|
0
|
|
Overall Study
Infant died, so mother withdrawn
|
34
|
0
|
0
|
0
|
Baseline Characteristics
The numbers shown here are the number of mothers (not the number of infants).Infant age was not collected as all infants were enrolled around the time of birth.
Baseline characteristics by cohort
| Measure |
Prospective Cohort Study - Quantitative
n=2184 Participants
Mothers and their low-birth weight babies will be enrolled 72 hours after birth and followed through 12 months postpartum. The prospective cohort survey (which includes anthropometric measurements and feeding observations) occurs at multiple time points over this 12-month period.
|
In-facility Observations
n=290 Participants
Moderately low birthweight (1500 to \< 2500g) infants and their mothers were enrolled during their admission to the postnatal ward or neonatal intensive care unit.
|
Total
n=2474 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25.4 Years
STANDARD_DEVIATION 5.3 • n=1070 Participants • The numbers shown here are the number of mothers (not the number of infants).Infant age was not collected as all infants were enrolled around the time of birth.
|
26.5 Years
STANDARD_DEVIATION 6.1 • n=142 Participants • The numbers shown here are the number of mothers (not the number of infants).Infant age was not collected as all infants were enrolled around the time of birth.
|
25.8 Years
STANDARD_DEVIATION 5.4 • n=1212 Participants • The numbers shown here are the number of mothers (not the number of infants).Infant age was not collected as all infants were enrolled around the time of birth.
|
|
Sex: Female, Male
Infant Sex · Female
|
608 Participants
n=1114 Participants • We have differentiated the baseline sex between infants and mothers and presented a row for each sub-group
|
85 Participants
n=148 Participants • We have differentiated the baseline sex between infants and mothers and presented a row for each sub-group
|
693 Participants
n=1262 Participants • We have differentiated the baseline sex between infants and mothers and presented a row for each sub-group
|
|
Sex: Female, Male
Infant Sex · Male
|
506 Participants
n=1114 Participants • We have differentiated the baseline sex between infants and mothers and presented a row for each sub-group
|
63 Participants
n=148 Participants • We have differentiated the baseline sex between infants and mothers and presented a row for each sub-group
|
569 Participants
n=1262 Participants • We have differentiated the baseline sex between infants and mothers and presented a row for each sub-group
|
|
Sex: Female, Male
Mothers sex · Female
|
1070 Participants
n=1070 Participants • We have differentiated the baseline sex between infants and mothers and presented a row for each sub-group
|
142 Participants
n=142 Participants • We have differentiated the baseline sex between infants and mothers and presented a row for each sub-group
|
1212 Participants
n=1212 Participants • We have differentiated the baseline sex between infants and mothers and presented a row for each sub-group
|
|
Sex: Female, Male
Mothers sex · Male
|
0 Participants
n=1070 Participants • We have differentiated the baseline sex between infants and mothers and presented a row for each sub-group
|
0 Participants
n=142 Participants • We have differentiated the baseline sex between infants and mothers and presented a row for each sub-group
|
0 Participants
n=1212 Participants • We have differentiated the baseline sex between infants and mothers and presented a row for each sub-group
|
|
Race/Ethnicity, Customized
South Asian Infants
|
506 Participants
n=1114 Participants • This is the number of infants and mothers; we have presented data by sub-group.
|
73 Participants
n=148 Participants • This is the number of infants and mothers; we have presented data by sub-group.
|
579 Participants
n=1262 Participants • This is the number of infants and mothers; we have presented data by sub-group.
|
|
Race/Ethnicity, Customized
African Infants
|
608 Participants
n=1114 Participants • This is the number of infants and mothers; we have presented data by sub-group.
|
75 Participants
n=148 Participants • This is the number of infants and mothers; we have presented data by sub-group.
|
683 Participants
n=1262 Participants • This is the number of infants and mothers; we have presented data by sub-group.
|
|
Race/Ethnicity, Customized
South Asian Mothers
|
497 Participants
n=1070 Participants • This is the number of infants and mothers; we have presented data by sub-group.
|
72 Participants
n=142 Participants • This is the number of infants and mothers; we have presented data by sub-group.
|
569 Participants
n=1212 Participants • This is the number of infants and mothers; we have presented data by sub-group.
|
|
Race/Ethnicity, Customized
African Mothers
|
573 Participants
n=1070 Participants • This is the number of infants and mothers; we have presented data by sub-group.
|
70 Participants
n=142 Participants • This is the number of infants and mothers; we have presented data by sub-group.
|
643 Participants
n=1212 Participants • This is the number of infants and mothers; we have presented data by sub-group.
|
|
Region of Enrollment
Malawi · Mothers
|
273 Participants
n=573 Participants • Infants and mothers are presented separately.
|
35 Participants
n=70 Participants • Infants and mothers are presented separately.
|
308 Participants
n=643 Participants • Infants and mothers are presented separately.
|
|
Region of Enrollment
Malawi · Infants
|
300 Participants
n=573 Participants • Infants and mothers are presented separately.
|
35 Participants
n=70 Participants • Infants and mothers are presented separately.
|
335 Participants
n=643 Participants • Infants and mothers are presented separately.
|
|
Region of Enrollment
Tanzania · Mothers
|
300 Participants
n=608 Participants • Infants and mothers are presented separately.
|
35 Participants
n=75 Participants • Infants and mothers are presented separately.
|
335 Participants
n=683 Participants • Infants and mothers are presented separately.
|
|
Region of Enrollment
Tanzania · Infants
|
308 Participants
n=608 Participants • Infants and mothers are presented separately.
|
40 Participants
n=75 Participants • Infants and mothers are presented separately.
|
348 Participants
n=683 Participants • Infants and mothers are presented separately.
|
|
Region of Enrollment
India · Mothers
|
497 Participants
n=1003 Participants • Infants and mothers are presented separately.
|
72 Participants
n=145 Participants • Infants and mothers are presented separately.
|
569 Participants
n=1148 Participants • Infants and mothers are presented separately.
|
|
Region of Enrollment
India · Infants
|
506 Participants
n=1003 Participants • Infants and mothers are presented separately.
|
73 Participants
n=145 Participants • Infants and mothers are presented separately.
|
579 Participants
n=1148 Participants • Infants and mothers are presented separately.
|
|
Maternal Education
Primary or less
|
501 Participants
n=1070 Participants • This is the number of mothers (not the number of infants).
|
63 Participants
n=142 Participants • This is the number of mothers (not the number of infants).
|
564 Participants
n=1212 Participants • This is the number of mothers (not the number of infants).
|
|
Maternal Education
Secondary or more
|
569 Participants
n=1070 Participants • This is the number of mothers (not the number of infants).
|
79 Participants
n=142 Participants • This is the number of mothers (not the number of infants).
|
648 Participants
n=1212 Participants • This is the number of mothers (not the number of infants).
|
PRIMARY outcome
Timeframe: At 6 month of agePopulation: Low birth weight infants. This outcome was only collected on the quantitative prospective cohort population.
A Child's length-for-age z-score at 6 months of age. Length-for-age z-scores (LAZ) are based on World Health Organization (WHO) child growth standards for term infants and INTERGROWTH-21st standards were used for preterm infants. A LAZ Z-score of 0 represents the population mean and scores below 0 represent a worse outcome. Further, Z-scores less than -2.0 indicates stunting in the infant.
Outcome measures
| Measure |
Prospective Cohort Study - Quantitative
n=1114 Participants
Mothers and their low-birth weight babies will be enrolled 72 hours after birth and followed through 12 months postpartum. The prospective cohort survey (which includes anthropometric measurements and feeding observations) occurs at multiple time points over this 12-month period.
This outcome (like all others reported) was only assessed in the prospective cohort and not in the in-facility observations, Donor human milk readiness assessment, prospective cohort qualitative or the retrospective chart review.
|
|---|---|
|
Length-for-Age Z-score
|
-1.43 Z-score
Standard Deviation 1.28
|
PRIMARY outcome
Timeframe: At 12 month of agePopulation: Low birth weight infants; This outcome was only collected on the quantitative prospective cohort population.
A Child's length-for-age z-score at 12 months of age. A Child's length-for-age z-score at 12 months of age. Length-for-age (LAZ) z-scores were based on World Health Organization (WHO) growth standards for term infants and preterm infants; we corrected for gestational age (GA) for preterm infants. A LAZ z-score of 0 represents the population mean and scores below 0 represent a worse outcome. Further, Z-scores less than -2.0 indicates an infant who is underweight.
Outcome measures
| Measure |
Prospective Cohort Study - Quantitative
n=1114 Participants
Mothers and their low-birth weight babies will be enrolled 72 hours after birth and followed through 12 months postpartum. The prospective cohort survey (which includes anthropometric measurements and feeding observations) occurs at multiple time points over this 12-month period.
This outcome (like all others reported) was only assessed in the prospective cohort and not in the in-facility observations, Donor human milk readiness assessment, prospective cohort qualitative or the retrospective chart review.
|
|---|---|
|
Length-for-Age Z-score
|
-1.58 Z-score
Standard Deviation 1.21
|
SECONDARY outcome
Timeframe: 6 month postpartumPopulation: Low Birth Weight Infants; This outcome was only collected on the quantitative prospective cohort population.
Maternal Report of Ever having Diarrheal Disease from weeks 1 to 6 months of age
Outcome measures
| Measure |
Prospective Cohort Study - Quantitative
n=1114 Participants
Mothers and their low-birth weight babies will be enrolled 72 hours after birth and followed through 12 months postpartum. The prospective cohort survey (which includes anthropometric measurements and feeding observations) occurs at multiple time points over this 12-month period.
This outcome (like all others reported) was only assessed in the prospective cohort and not in the in-facility observations, Donor human milk readiness assessment, prospective cohort qualitative or the retrospective chart review.
|
|---|---|
|
Incidence of Diarrheal Disease
|
130 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At 6 month of agePopulation: Low Birth Weight Infants; This outcome was only collected on the quantitative prospective cohort population.
Child's weight-for-age z-score. Weight-for-age (WAZ) z-scores at 6 months of age were based on WHO growth standards for term infants and INTERGROWTH- 21st standards, for preterm infants. A Z-score of 0 represents the population mean, and Z-scores below 0 represent a worse outcome. Further, WAZ Z-scores less than -2 indicates an infant who is underweight.
Outcome measures
| Measure |
Prospective Cohort Study - Quantitative
n=1114 Participants
Mothers and their low-birth weight babies will be enrolled 72 hours after birth and followed through 12 months postpartum. The prospective cohort survey (which includes anthropometric measurements and feeding observations) occurs at multiple time points over this 12-month period.
This outcome (like all others reported) was only assessed in the prospective cohort and not in the in-facility observations, Donor human milk readiness assessment, prospective cohort qualitative or the retrospective chart review.
|
|---|---|
|
Weight-for-age Z-score
|
-1.23 Z-score
Standard Deviation 1.20
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months of agePopulation: Low birth weight infants; This outcome was only collected on the quantitative prospective cohort population.
Infants who were stunted and/or wasted and/or underweight according to WHO Growth Standards at 6 months of age. A Z-score of 0 represents the population mean, and Z-scores below 0 represent a worse outcome Infants who have Z-score (weight for age; length for age; or weight for length) less than -2 are considered malnourished.
Outcome measures
| Measure |
Prospective Cohort Study - Quantitative
n=1114 Participants
Mothers and their low-birth weight babies will be enrolled 72 hours after birth and followed through 12 months postpartum. The prospective cohort survey (which includes anthropometric measurements and feeding observations) occurs at multiple time points over this 12-month period.
This outcome (like all others reported) was only assessed in the prospective cohort and not in the in-facility observations, Donor human milk readiness assessment, prospective cohort qualitative or the retrospective chart review.
|
|---|---|
|
Percentage of Infants Malnourished at 6 Months
|
373 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 months of agePopulation: Low birth weight infants
Infants who were stunted and/or wasted and/or underweight according to WHO Growth Standards at 12 months of age. A Z-score of 0 represents the population mean, and Z-scores below 0 represent a worse outcome Infants who have Z-score (weight for age; length for age; or weight for length) less than -2 are considered malnourished.
Outcome measures
| Measure |
Prospective Cohort Study - Quantitative
n=1114 Participants
Mothers and their low-birth weight babies will be enrolled 72 hours after birth and followed through 12 months postpartum. The prospective cohort survey (which includes anthropometric measurements and feeding observations) occurs at multiple time points over this 12-month period.
This outcome (like all others reported) was only assessed in the prospective cohort and not in the in-facility observations, Donor human milk readiness assessment, prospective cohort qualitative or the retrospective chart review.
|
|---|---|
|
Percentage of Infants Malnourished at 12 Months
|
518 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At 12 month of agePopulation: Low Birth Weight Infants; This outcome was only collected on the quantitative prospective cohort population.
Child's weight-for-age z-score. Child's weight-for-age z-score. Weight-for-age (WAZ) z-scores at 12 months were based on WHO growth standards for term infants and preterm infants. A Z-score of 0 represents the population mean, and Z-scores below 0 represent a worse outcome. Further, WAZ Z-scores less than -2 indicates an infant who is underweight.
Outcome measures
| Measure |
Prospective Cohort Study - Quantitative
n=1114 Participants
Mothers and their low-birth weight babies will be enrolled 72 hours after birth and followed through 12 months postpartum. The prospective cohort survey (which includes anthropometric measurements and feeding observations) occurs at multiple time points over this 12-month period.
This outcome (like all others reported) was only assessed in the prospective cohort and not in the in-facility observations, Donor human milk readiness assessment, prospective cohort qualitative or the retrospective chart review.
|
|---|---|
|
Weight-for-age Z-score
|
-1.28 Z-score
Standard Deviation 1.12
|
Adverse Events
Prospective Cohort Study - Quantitative: Infants
Serious events: 172 serious events
Other events: 0 other events
Deaths: 37 deaths
Prospective Cohort Study - Quantitative: Mothers
Serious events: 22 serious events
Other events: 0 other events
Deaths: 4 deaths
In-facility Observations
Serious events: 8 serious events
Other events: 0 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Prospective Cohort Study - Quantitative: Infants
n=1114 participants at risk
Mothers and their low-birth weight babies will be enrolled 72 hours after birth and followed through 12 months postpartum. The prospective cohort survey (which includes anthropometric measurements and feeding observations) occurs at multiple time points over this 12-month period.
Only the prospective cohort quantitative arm is included in adverse arm reporting since this was the longitudinal, prospective cohort for which we reported outcomes and reported adverse events.
|
Prospective Cohort Study - Quantitative: Mothers
n=1070 participants at risk
Mothers and their low-birth weight babies will be enrolled 72 hours after birth and followed through 12 months postpartum. The prospective cohort survey (which includes anthropometric measurements and feeding observations) occurs at multiple time points over this 12-month period.
Only the prospective cohort quantitative arm is included in adverse arm reporting since this was the longitudinal, prospective cohort for which we reported outcomes and reported adverse events.
|
In-facility Observations
n=142 participants at risk
Low-birthweight infants were followed during their in-facility stay and followed until facility discharge.
|
|---|---|---|---|
|
Gastrointestinal disorders
Malnutrition
|
10.1%
113/1114 • 1 year
All-cause mortality was collected from prospective cohort mothers, infants, and infants in the in-facility cohort. Adverse events (AE) were only collected on infants and mothers in prospective cohorts and in-facility cohort: infants. AE was monitored so that specific AE Terms could not be separated for infants (n=1114). We did not collect AE data on the qualitative cohorts (mothers or infants) or the retrospective chart review/donor human milk readiness assessment.
|
0.93%
10/1070 • 1 year
All-cause mortality was collected from prospective cohort mothers, infants, and infants in the in-facility cohort. Adverse events (AE) were only collected on infants and mothers in prospective cohorts and in-facility cohort: infants. AE was monitored so that specific AE Terms could not be separated for infants (n=1114). We did not collect AE data on the qualitative cohorts (mothers or infants) or the retrospective chart review/donor human milk readiness assessment.
|
0.00%
0/142 • 1 year
All-cause mortality was collected from prospective cohort mothers, infants, and infants in the in-facility cohort. Adverse events (AE) were only collected on infants and mothers in prospective cohorts and in-facility cohort: infants. AE was monitored so that specific AE Terms could not be separated for infants (n=1114). We did not collect AE data on the qualitative cohorts (mothers or infants) or the retrospective chart review/donor human milk readiness assessment.
|
|
General disorders
Severe Illness
|
0.63%
7/1114 • 1 year
All-cause mortality was collected from prospective cohort mothers, infants, and infants in the in-facility cohort. Adverse events (AE) were only collected on infants and mothers in prospective cohorts and in-facility cohort: infants. AE was monitored so that specific AE Terms could not be separated for infants (n=1114). We did not collect AE data on the qualitative cohorts (mothers or infants) or the retrospective chart review/donor human milk readiness assessment.
|
0.00%
0/1070 • 1 year
All-cause mortality was collected from prospective cohort mothers, infants, and infants in the in-facility cohort. Adverse events (AE) were only collected on infants and mothers in prospective cohorts and in-facility cohort: infants. AE was monitored so that specific AE Terms could not be separated for infants (n=1114). We did not collect AE data on the qualitative cohorts (mothers or infants) or the retrospective chart review/donor human milk readiness assessment.
|
0.00%
0/142 • 1 year
All-cause mortality was collected from prospective cohort mothers, infants, and infants in the in-facility cohort. Adverse events (AE) were only collected on infants and mothers in prospective cohorts and in-facility cohort: infants. AE was monitored so that specific AE Terms could not be separated for infants (n=1114). We did not collect AE data on the qualitative cohorts (mothers or infants) or the retrospective chart review/donor human milk readiness assessment.
|
|
General disorders
Other Illness
|
4.5%
50/1114 • 1 year
All-cause mortality was collected from prospective cohort mothers, infants, and infants in the in-facility cohort. Adverse events (AE) were only collected on infants and mothers in prospective cohorts and in-facility cohort: infants. AE was monitored so that specific AE Terms could not be separated for infants (n=1114). We did not collect AE data on the qualitative cohorts (mothers or infants) or the retrospective chart review/donor human milk readiness assessment.
|
1.1%
12/1070 • 1 year
All-cause mortality was collected from prospective cohort mothers, infants, and infants in the in-facility cohort. Adverse events (AE) were only collected on infants and mothers in prospective cohorts and in-facility cohort: infants. AE was monitored so that specific AE Terms could not be separated for infants (n=1114). We did not collect AE data on the qualitative cohorts (mothers or infants) or the retrospective chart review/donor human milk readiness assessment.
|
5.6%
8/142 • 1 year
All-cause mortality was collected from prospective cohort mothers, infants, and infants in the in-facility cohort. Adverse events (AE) were only collected on infants and mothers in prospective cohorts and in-facility cohort: infants. AE was monitored so that specific AE Terms could not be separated for infants (n=1114). We did not collect AE data on the qualitative cohorts (mothers or infants) or the retrospective chart review/donor human milk readiness assessment.
|
|
General disorders
Unknown Illness
|
0.18%
2/1114 • 1 year
All-cause mortality was collected from prospective cohort mothers, infants, and infants in the in-facility cohort. Adverse events (AE) were only collected on infants and mothers in prospective cohorts and in-facility cohort: infants. AE was monitored so that specific AE Terms could not be separated for infants (n=1114). We did not collect AE data on the qualitative cohorts (mothers or infants) or the retrospective chart review/donor human milk readiness assessment.
|
0.00%
0/1070 • 1 year
All-cause mortality was collected from prospective cohort mothers, infants, and infants in the in-facility cohort. Adverse events (AE) were only collected on infants and mothers in prospective cohorts and in-facility cohort: infants. AE was monitored so that specific AE Terms could not be separated for infants (n=1114). We did not collect AE data on the qualitative cohorts (mothers or infants) or the retrospective chart review/donor human milk readiness assessment.
|
0.00%
0/142 • 1 year
All-cause mortality was collected from prospective cohort mothers, infants, and infants in the in-facility cohort. Adverse events (AE) were only collected on infants and mothers in prospective cohorts and in-facility cohort: infants. AE was monitored so that specific AE Terms could not be separated for infants (n=1114). We did not collect AE data on the qualitative cohorts (mothers or infants) or the retrospective chart review/donor human milk readiness assessment.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place