Low BirthweightLIFENCT04002908
Low-birthweight Infant Feeding Exploration
An observational study of Low Birthweight and Pre-Term, run by Harvard School of Public Health (HSPH) at 3 sites in 3 countries.
Trial summary
Globally, 15% of all babies, amounting to 20 million infants each year, are born low birthweight (LBW), defined less than 2500 grams (5.5 lbs). Compared to normal weight infants, LBW infants are at higher risk of morbidity, mortality, and poor growth (Risnes et al 2011; Larroque et al 2001; WHO 2006). Read more about this study
- Who is it for?
- Ages 16 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Birthweight, Pre-Term
- How many people
- 3,188 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 31 Jul 2019to 29 Jul 2021
- Phase
- Observational
- 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 16 to 59 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Mothers and their LBW babies who are either born in the study health facilities or arrive within 72 hours of birth and meet eligibility criteria
Who may be able to join
- Infant birthweight between 1500 and <2500g (according to chart and then verified by study staff).
- Residence within catchment area of facility.
- Mother's consent obtained for herself and infant.
- Newborns must be enrolled within 72 hours of birth.
- Women (mothers) who are of age of majority in their respective countries.
- Currently enrolled in the LIFE study and fulfills all original inclusion criteria.
- Mother's or surrogate consent obtained for herself and infant for another 6 months of follow up.
Who cannot join
- Mother does not meet the local age of majority.
- Infant very low birthweight <1500g.
- Infant has congenital abnormality that interferes with feeding, which includes: Cleft lip or palate; Hydrocephalus; Gastrointestinal tract anomalies including gastroschisis, omphalocele, or anal atresia; Neural tube defects; Congenital cardiac defects; Suspected Trisomy 21; Suspected TORCH infection such as congenital rubella, cytomegalovirus (CMV), toxoplasmosis, or syphilis.
- Critical or severe illness jeopardizing early survival, specifically, investigators will exclude infants with severe encephalopathy as determined by modified Sarnat criteria.
- If the Infant dies before enrollment can occur.
- Infant has a twin or triplet that has died.
Show all 12Show fewer
- Plans to leave the study area before end of data collection.
- Infants must be enrolled in the prospective study within 72 hours of birth. If the infant is older than 72 hours at the time of screening, s/he will be ineligible for the study.
- Maternal death: The study will exclude cases of maternal death that occur during labor and delivery (or at any time before the consenting process would begin for this study).
- Maternal deaths will count as an exclusion criterion for the prospective cohort if they occur before enrollment. In the event that a mother dies at any time after enrollment the infant will still be retained in the cohort.
- 6-Month Extension Study Criteria:
- Not previously enrolled in the LIFE study in addition to all original exclusion criteria.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Globally, 15% of all babies, amounting to 20 million infants each year, are born low birthweight (LBW), defined less than 2500 grams (5.5 lbs). Compared to normal weight infants, LBW infants are at higher risk of morbidity, mortality, and poor growth (Risnes et al 2011; Larroque et al 2001; WHO 2006). The main causes of LBW are preterm birth, intrauterine growth restriction (IUGR), or their combination. Unfortunately, there is a paucity of information around feeding practices and optimal feeding strategies for this population, particularly for LBW infants who struggle with breastfeeding or growth. This study hopes to address these gaps.
Read the detailed description
The Low-birthweight Infant Feeding Exploration (LIFE)(original grant 0-6 months of age) and the 6- month extension (6-12 months of age) will fill a critical data gap in the field of newborn care regarding vulnerability and feeding of LBW infants. The investigators aim to establish the background information required to set up and test the most efficient and feasible infant feeding strategies for LBW infants: first to support breastfeeding, and then to support infants who are nutritionally at risk in the first 6 month of life in low and middle income countries (LMIC). The investigators will explore all three infant feeding options currently included in the WHO guidelines for LBW infants (WHO 2011), namely mother's own milk (MOM), donor human milk (DHM), and breast milk substitute or formula (BMS), in that order. This work will provide much-needed evidence to inform infant feeding guidelines.
In addition, this 6-month extension will allow for a more comprehensive exploration and understanding of feeding options for LBW infants from 6 to 12 months of age, accounting for timing of introduction of complementary liquids and foods, changes in feeding types, growth and health outcomes over the entire infancy period. This will contribute significantly and allow for high quality data to describe the burden of disease across sites. Specifically, we will be able to describe the following for LBW infants:
- Growth trajectories from 0 to 12 months of age
- Patterns and timing of complementary feeding and continued breastfeeding/breastmilk consumption
- Common infant morbidities and timing of mortality
- Maternal demographics, well-being and environmental factors affecting infant feeding and growth
The overall study goal is to understand feeding options for LBW infants in LMIC settings, including current feeding practices, health outcomes, and potential interventions. The study will take place in four study sites located in three countries: Tanzania, Malawi, and India. Each study site will encompass 2 to 5 individual study facilities. The three study objectives under the goal include:
- Understand the current practices and standard of care (SOC) for feeding LBW infants
- Define and document the key outcomes (including growth, morbidity, and lack of success on MOM) for LBW infants under current practices
- Assess the acceptability and feasibility of a system-level IYCF intervention and the proposed infant feeding options for LBW infants
The investigators will also use the results of this work to design ways to support exclusive breastfeeding (including strategies for feeding with MOM), and to support other options, when mother's own milk (MOM) is unavailable or infants are nutritionally at risk. To do this, the investigators will engage in discussion and consensus-building activities among study staff and key stakeholders, using the collected study data to inform feasible, acceptable Infant and Young Child Feeding (IYCF) strategies for LBW infants that include specific options for those who are nutritionally at risk. The strategies will be tailored to the country as much as possible. A primary product for this later stage will be a white paper documenting key findings from the research and proposing feeding strategies for LBW infants in study sites.
- Conditions
- Low Birthweight, Pre-Term
- Keywords
- Infant Health, Low and Middle Income Countries [LMIC], Maternal Health, Infant Feeding, Low Birthweight
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| In-facility Observations | Mothers and their LBW babies will be observed starting within 6 hours of birth until the baby is discharged from the health facility. | |
| 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. | |
| Prospective cohort study - Qualitative | Research specialists at each site will be speaking to key informants (includes doctors, nurses, midwives, community health workers (CHWs), Ministry of Health (MOH) officials, supply chain \& milk bank experts) who are knowledgeable about breastfeeding policy, supply chain, or milk banks. Clinicians in study health facilities who work on labor and delivery, postnatal, newborn and neonatal ICU wards. They participate in In-depth interviews. Mothers, family members and health care workers of LBW babies, as well as community leaders (including religious leaders) who are knowledgeable about infant feeding in their communities will participate in focus group discussions. Focus group discussion will take up to 2 hours. In-depth interviews will take up to 1 hour. Mothers (6-month extension): Mothers chosen and consented for in-depth interviews (IDIs) will include those currently enrolled in the prospective cohort. Additionally, their infants need to be between 9 and 12 months of age. | |
| Retrospective Chart review | The retrospective chart review is a review of secondary data of mothers and their LBW babies who were born in the study health facilities prior to the start of the study. | |
| Donor Human Milk Readiness Assessment | Key stakeholders in the area of newborn health who determine policy and procedures or who are directly involved with the provision of care. This includes clinicians, nurses, lactation/nutrition specialists, hospital leadership and/or Ministry of Health officials present in the study health facilities. This is a one-time data collection exercise in the form of either: (1) a largely qualitative facility readiness assessment tool with some qualitative questions for facility staff or (2) a facility tool observing the "flow of milk" along with key informant interviews in the study facilities. This could take anywhere from 1hr to a day depending on the tool administered, key informants involved and size of the study facility. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length-for-Age Z-score
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.
Measured: At 6 month of age
Length-for-Age Z-score
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.
Measured: At 12 month of age
Secondary outcomes (1)
Incidence of Diarrheal Disease
Maternal Report of Ever having Diarrheal Disease from weeks 1 to 6 months of age
Measured: 6 month postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start31 Jul 2019
- Primary completion29 Jul 2021
- Study completion29 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Low BirthweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Emory University, Boston Children's Hospital, Brigham and Women's Hospital, PATH, University of North Carolina, Chapel Hill, Jawaharlal Nehru Medical College, Muhimbili University of Health and Allied Sciences, University of North Carolina, Ariadne Labs
- Responsible party
- Principal investigator, Katherine Semrau, Harvard School of Public Health (HSPH)
- Investigators
- Katherine Semrau, PhD, MPH, Principal investigator, Ariadne Labs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04002908
- Sponsor's protocol ID
- HSPH OPP1192260
- Acronym
- LIFE
- Status last verified
- Apr 2025
- First submitted
- 27 Jun 2019
- Last updated
- 27 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A de-identified dataset will be available through Harvard Dataverse for the LIFE data. A prospective cohort data set will be available and a in-facility observation cohort will be available.
Publications
Mvalo T, Dhaded SM, Manji KP, Vesel L, Semrau KEA, Kisenge R, Somji S, Chiume M, Saidi F, Hoffman IF, Vernekar S, Bellad R, Koppad B, Tuller DE, Mokhtar R, Lee ACC, North K, Sudfeld CR. Mortality, morbidity and growth among moderately low birthweight infants in India, Malawi, and Tanzania. BMC Pediatr. 2025 Apr 23;25(1):316. doi: 10.1186/s12887-025-05668-8.
PubMed 40264138North K, Semrau KEA, Bellad RM, Dhaded SM, Das L, Behera JN, Hoffman I, Mvalo T, Kisenge R, Sudfeld CR, Somji S, Mokhtar RR, Vesel L, Goudar S, Vernekar SS, Siddhartha ES, Singh B, Koujalagi MB, Panda S, Kafansiyanji E, Nyirenda N, Phiri M, Saidi F, Masoud NS, Moshiro R, Tuller DE, Israel-Ballard K, Duggan CP, Lee ACC, Mansen KL, Young MF, Manji K; LIFE study team. The Association Between Breastfeeding and Growth Among Infants with Moderately Low Birth Weight: A Prospective Cohort Study. J Pediatr. 2024 Jun;269:114003. doi: 10.1016/j.jpeds.2024.114003. Epub 2024 Mar 4.
PubMed 38447758Vesel L, Bellad RM, Manji K, Saidi F, Velasquez E, Sudfeld CR, Miller K, Bakari M, Lugangira K, Kisenge R, Salim N, Somji S, Hoffman I, Msimuko K, Mvalo T, Nyirenda F, Phiri M, Das L, Dhaded S, Goudar SS, Herekar V, Kumar Y, Koujalagi MB, Guruprasad G, Panda S, Shamanur LG, Somannavar M, Vernekar SS, Misra S, Adair L, Bell G, Caruso BA, Duggan C, Fleming K, Israel-Ballard K, Fishman E, Lee ACC, Lipsitz S, Mansen KL, Martin SL, Mokhtar RR, North K, Pote A, Spigel L, Tuller DE, Young M, Semrau KEA; LIFE study team. Feeding practices and growth patterns of moderately low birthweight infants in resource-limited settings: results from a multisite, longitudinal observational study. BMJ Open. 2023 Feb 15;13(2):e067316. doi: 10.1136/bmjopen-2022-067316.
PubMed 36792338Vesel L, Spigel L, Behera JN, Bellad RM, Das L, Dhaded S, Goudar SS, Guruprasad G, Misra S, Panda S, Shamanur LG, Vernekar SS, Hoffman IF, Mvalo T, Phiri M, Saidi F, Kisenge R, Manji K, Salim N, Somji S, Sudfeld CR, Adair L, Caruso BA, Duggan C, Israel-Ballard K, Lee AC, Martin SL, Mansen KL, North K, Young M, Benotti E, Marx Delaney M, Fishman E, Fleming K, Henrich N, Miller K, Subramanian L, Tuller DE, Semrau KE. Mixed-methods, descriptive and observational cohort study examining feeding and growth patterns among low birthweight infants in India, Malawi and Tanzania: the LIFE study protocol. BMJ Open. 2021 Dec 2;11(12):e048216. doi: 10.1136/bmjopen-2020-048216.
PubMed 34857554
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-birthweight Infant Feeding Exploration
- ClinicalTrials.gov ID
- NCT04002908
- Acronym / sponsor ID
- LIFE / HSPH OPP1192260
- Conditions
- Low Birthweight, Pre-Term
- Keywords
- Infant Health, Low and Middle Income Countries [LMIC], Maternal Health, Infant Feeding, Low Birthweight
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,188 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Emory University, Boston Children's Hospital, Brigham and Women's Hospital, PATH, University of North Carolina, Chapel Hill, Jawaharlal Nehru Medical College, Muhimbili University of Health and Allied Sciences, University of North Carolina, Ariadne Labs
- Study start
- 31 Jul 2019 (actual)
- Primary completion
- 29 Jul 2021 (actual)
- Study completion
- 29 Jul 2021 (actual)
- First posted
- 1 Jul 2019 (actual)
- Results
- Posted 27 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Globally, 15% of all babies, amounting to 20 million infants each year, are born low birthweight (LBW), defined less than 2500 grams (5.5 lbs). Compared to normal weight infants, LBW infants are at higher risk of morbidity, mortality, and poor growth (Risnes et al 2011; Larroque et al 2001; WHO 2006). The main causes of LBW are preterm birth, intrauterine growth restriction (IUGR), or their combination. Unfortunately, there is a paucity of information around feeding practices and optimal feeding strategies for this population, particularly for LBW infants who struggle with breastfeeding or growth. This study hopes to address these gaps.
Detailed description
The Low-birthweight Infant Feeding Exploration (LIFE)(original grant 0-6 months of age) and the 6- month extension (6-12 months of age) will fill a critical data gap in the field of newborn care regarding vulnerability and feeding of LBW infants. The investigators aim to establish the background information required to set up and test the most efficient and feasible infant feeding strategies for LBW infants: first to support breastfeeding, and then to support infants who are nutritionally at risk in the first 6 month of life in low and middle income countries (LMIC). The investigators will explore all three infant feeding options currently included in the WHO guidelines for LBW infants (WHO 2011), namely mother's own milk (MOM), donor human milk (DHM), and breast milk substitute or formula (BMS), in that order. This work will provide much-needed evidence to inform infant feeding guidelines.
In addition, this 6-month extension will allow for a more comprehensive exploration and understanding of feeding options for LBW infants from 6 to 12 months of age, accounting for timing of introduction of complementary liquids and foods, changes in feeding types, growth and health outcomes over the entire infancy period. This will contribute significantly and allow for high quality data to describe the burden of disease across sites. Specifically, we will be able to describe the following for LBW infants:
- Growth trajectories from 0 to 12 months of age
- Patterns and timing of complementary feeding and continued breastfeeding/breastmilk consumption
- Common infant morbidities and timing of mortality
- Maternal demographics, well-being and environmental factors affecting infant feeding and growth
The overall study goal is to understand feeding options for LBW infants in LMIC settings, including current feeding practices, health outcomes, and potential interventions. The study will take place in four study sites located in three countries: Tanzania, Malawi, and India. Each study site will encompass 2 to 5 individual study facilities. The three study objectives under the goal include:
- Understand the current practices and standard of care (SOC) for feeding LBW infants
- Define and document the key outcomes (including growth, morbidity, and lack of success on MOM) for LBW infants under current practices
- Assess the acceptability and feasibility of a system-level IYCF intervention and the proposed infant feeding options for LBW infants
The investigators will also use the results of this work to design ways to support exclusive breastfeeding (including strategies for feeding with MOM), and to support other options, when mother's own milk (MOM) is unavailable or infants are nutritionally at risk. To do this, the investigators will engage in discussion and consensus-building activities among study staff and key stakeholders, using the collected study data to inform feasible, acceptable Infant and Young Child Feeding (IYCF) strategies for LBW infants that include specific options for those who are nutritionally at risk. The strategies will be tailored to the country as much as possible. A primary product for this later stage will be a white paper documenting key findings from the research and proposing feeding strategies for LBW infants in study sites.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| In-facility Observations | – | –Mothers and their LBW babies will be observed starting within 6 hours of birth until the baby is discharged from the health facility. |
| 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. |
| Prospective cohort study - Qualitative | – | –Research specialists at each site will be speaking to key informants (includes doctors, nurses, midwives, community health workers (CHWs), Ministry of Health (MOH) officials, supply chain \& milk bank experts) who are knowledgeable about breastfeeding policy, supply chain, or milk banks. Clinicians in study health facilities who work on labor and delivery, postnatal, newborn and neonatal ICU wards. They participate in In-depth interviews. Mothers, family members and health care workers of LBW babies, as well as community leaders (including religious leaders) who are knowledgeable about infant feeding in their communities will participate in focus group discussions. Focus group discussion will take up to 2 hours. In-depth interviews will take up to 1 hour. Mothers (6-month extension): Mothers chosen and consented for in-depth interviews (IDIs) will include those currently enrolled in the prospective cohort. Additionally, their infants need to be between 9 and 12 months of age. |
| Retrospective Chart review | – | –The retrospective chart review is a review of secondary data of mothers and their LBW babies who were born in the study health facilities prior to the start of the study. |
| Donor Human Milk Readiness Assessment | – | –Key stakeholders in the area of newborn health who determine policy and procedures or who are directly involved with the provision of care. This includes clinicians, nurses, lactation/nutrition specialists, hospital leadership and/or Ministry of Health officials present in the study health facilities. This is a one-time data collection exercise in the form of either: (1) a largely qualitative facility readiness assessment tool with some qualitative questions for facility staff or (2) a facility tool observing the "flow of milk" along with key informant interviews in the study facilities. This could take anywhere from 1hr to a day depending on the tool administered, key informants involved and size of the study facility. |
Who may qualify
- Ages
- 16 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Mothers and their LBW babies who are either born in the study health facilities or arrive within 72 hours of birth and meet eligibility criteria
Key inclusion criteria (7 listed)
- Infant birthweight between 1500 and <2500g (according to chart and then verified by study staff).
- Residence within catchment area of facility.
- Mother's consent obtained for herself and infant.
- Newborns must be enrolled within 72 hours of birth.
- Women (mothers) who are of age of majority in their respective countries.
Key exclusion criteria (12 listed)
- Mother does not meet the local age of majority.
- Infant very low birthweight <1500g.
- Infant has congenital abnormality that interferes with feeding, which includes: Cleft lip or palate; Hydrocephalus; Gastrointestinal tract anomalies including gastroschisis, omphalocele, or anal atresia; Neural tube defects; Congenital cardiac defects; Suspected Trisomy 21; Suspected TORCH infection such as congenital rubella, cytomegalovirus (CMV), toxoplasmosis, or syphilis.
- Critical or severe illness jeopardizing early survival, specifically, investigators will exclude infants with severe encephalopathy as determined by modified Sarnat criteria.
- If the Infant dies before enrollment can occur.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Length-for-Age Z-score
Time frame: At 6 month of age
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.
Length-for-Age Z-score
Time frame: At 12 month of age
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.
1 secondary outcome
Incidence of Diarrheal Disease
Time frame: 6 month postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40264138Mvalo T, Dhaded SM, Manji KP, Vesel L, Semrau KEA, Kisenge R, Somji S, Chiume M, Saidi F, Hoffman IF, Vernekar S, Bellad R, Koppad B, Tuller DE, Mokhtar R, Lee ACC, North K, Sudfeld CR. Mortality, morbidity and growth among moderately low birthweight infants in India, Malawi, and Tanzania. BMC Pediatr. 2025 Apr 23;25(1):316. doi: 10.1186/s12887-025-05668-8.
- Derived from this study: PubMed 38447758North K, Semrau KEA, Bellad RM, Dhaded SM, Das L, Behera JN, Hoffman I, Mvalo T, Kisenge R, Sudfeld CR, Somji S, Mokhtar RR, Vesel L, Goudar S, Vernekar SS, Siddhartha ES, Singh B, Koujalagi MB, Panda S, Kafansiyanji E, Nyirenda N, Phiri M, Saidi F, Masoud NS, Moshiro R, Tuller DE, Israel-Ballard K, Duggan CP, Lee ACC, Mansen KL, Young MF, Manji K; LIFE study team. The Association Between Breastfeeding and Growth Among Infants with Moderately Low Birth Weight: A Prospective Cohort Study. J Pediatr. 2024 Jun;269:114003. doi: 10.1016/j.jpeds.2024.114003. Epub 2024 Mar 4.
- Derived from this study: PubMed 36792338Vesel L, Bellad RM, Manji K, Saidi F, Velasquez E, Sudfeld CR, Miller K, Bakari M, Lugangira K, Kisenge R, Salim N, Somji S, Hoffman I, Msimuko K, Mvalo T, Nyirenda F, Phiri M, Das L, Dhaded S, Goudar SS, Herekar V, Kumar Y, Koujalagi MB, Guruprasad G, Panda S, Shamanur LG, Somannavar M, Vernekar SS, Misra S, Adair L, Bell G, Caruso BA, Duggan C, Fleming K, Israel-Ballard K, Fishman E, Lee ACC, Lipsitz S, Mansen KL, Martin SL, Mokhtar RR, North K, Pote A, Spigel L, Tuller DE, Young M, Semrau KEA; LIFE study team. Feeding practices and growth patterns of moderately low birthweight infants in resource-limited settings: results from a multisite, longitudinal observational study. BMJ Open. 2023 Feb 15;13(2):e067316. doi: 10.1136/bmjopen-2022-067316.
- Derived from this study: PubMed 34857554Vesel L, Spigel L, Behera JN, Bellad RM, Das L, Dhaded S, Goudar SS, Guruprasad G, Misra S, Panda S, Shamanur LG, Vernekar SS, Hoffman IF, Mvalo T, Phiri M, Saidi F, Kisenge R, Manji K, Salim N, Somji S, Sudfeld CR, Adair L, Caruso BA, Duggan C, Israel-Ballard K, Lee AC, Martin SL, Mansen KL, North K, Young M, Benotti E, Marx Delaney M, Fishman E, Fleming K, Henrich N, Miller K, Subramanian L, Tuller DE, Semrau KE. Mixed-methods, descriptive and observational cohort study examining feeding and growth patterns among low birthweight infants in India, Malawi and Tanzania: the LIFE study protocol. BMJ Open. 2021 Dec 2;11(12):e048216. doi: 10.1136/bmjopen-2020-048216.
- Harvard Dataverse with LIFE study data available.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. A de-identified dataset will be available through Harvard Dataverse for the LIFE data. A prospective cohort data set will be available and a in-facility observation cohort will be available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine Semrau, PhD, MPH principal investigator
Ariadne Labs
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Birthweight and Pre-Term, run by Harvard School of Public Health (HSPH) at 3 sites in 3 countries.
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 7 inclusion and 12 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 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in India, Malawi, Tanzania. 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 27 Apr 2025). 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?
Length-for-Age Z-score (time frame: At 6 month of age). The study lists 2 primary outcomes in all. 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 NCT04002908, which also lists 4 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 27 Apr 2025.