An observational study in Low Birthweight and Pre-Term, sponsored by Harvard School of Public Health (HSPH). Completed at 3 sites in 3 countries. Open to participants aged 16 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-27.
Sponsored by Harvard School of Public Health (HSPH) · Observational
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.
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:
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:
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.
445 studies on the registry are indexed under Birth Weight; 36 are open to participants now.
This study's enrollment of 3,188 is above the median of 212 across 136 observational studies indexed under Birth Weight.
Browse Birth Weight studies →Harvard School of Public Health (HSPH) is the lead sponsor of 150 studies on the registry; 9 are open to participants now.
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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
Inclusion Criteria:
Exclusion Criteria:
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:
Inclusion criteria for the mother/infant pair are:
Exclusion criteria for the mother/infant pair are:
Mothers and their LBW babies will be observed starting within 6 hours of birth until the baby is discharged from the health facility.
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.
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.
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.
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.
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.
Time frame: 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.
Time frame: At 12 month of age
Incidence of Diarrheal Disease
Maternal Report of Ever having Diarrheal Disease from weeks 1 to 6 months of age
Time frame: 6 month postpartum
Weight-for-age Z-score
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.
Time frame: At 6 month of age
Percentage of Infants Malnourished at 6 Months
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.
Time frame: 6 months of age
Percentage of Infants Malnourished at 12 Months
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.
Time frame: 12 months of age
Weight-for-age Z-score
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.
Time frame: At 12 month of age
| Milestone | Prospective Cohort Study - Quantitative | In-facility Observations | Prospective Cohort Study - Qualitative | LIFE Study: Retrospective Chart Review & Donor Human Milk Readiness Assessment |
|---|---|---|---|---|
| Started | 2184 | 290 | 355 | 359 |
| Completed | 1925 | 290 | 355 | 359 |
| Not completed | 259 | 0 | 0 | 0 |
| Withdrew: Death | 41 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 112 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 72 | 0 | 0 | 0 |
| Withdrew: Infant died, so mother withdrawn | 34 | 0 | 0 | 0 |
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.
| Z-score | Prospective Cohort Study - Quantitative |
|---|---|
| Length-for-Age Z-score | -1.43 ± 1.28 |
Maternal Report of Ever having Diarrheal Disease from weeks 1 to 6 months of age
| Participants | Prospective Cohort Study - Quantitative |
|---|---|
| Incidence of Diarrheal Disease | 130 |
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.
| Z-score | Prospective Cohort Study - Quantitative |
|---|---|
| Weight-for-age Z-score | -1.23 ± 1.20 |
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.
| Participants | Prospective Cohort Study - Quantitative |
|---|---|
| Percentage of Infants Malnourished at 6 Months | 373 |
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.
| Participants | Prospective Cohort Study - Quantitative |
|---|---|
| Percentage of Infants Malnourished at 12 Months | 518 |
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.
| Z-score | Prospective Cohort Study - Quantitative |
|---|---|
| Weight-for-age Z-score | -1.28 ± 1.12 |
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.
| Z-score | Prospective Cohort Study - Quantitative |
|---|---|
| Length-for-Age Z-score | -1.58 ± 1.21 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Prospective Cohort Study - Quantitative: Infants | 37/1,114 (3.3%) | 172/1,114 (15.4%) | 0/1,114 (0%) |
| Prospective Cohort Study - Quantitative: Mothers | 4/1,070 (0.4%) | 22/1,070 (2.1%) | 0/1,070 (0%) |
| In-facility Observations | 3/142 (2.1%) | 8/142 (5.6%) | 0/142 (0%) |
| Event | Prospective Cohort Study - Quantitative: Infants | Prospective Cohort Study - Quantitative: Mothers | In-facility Observations |
|---|---|---|---|
| MalnutritionGastrointestinal disorders | 113/1114 | 10/1070 | 0/142 |
| Other IllnessGeneral disorders | 50/1114 | 12/1070 | 8/142 |
| Severe IllnessGeneral disorders | 7/1114 | 0/1070 | 0/142 |
| Unknown IllnessGeneral disorders | 2/1114 | 0/1070 | 0/142 |
A total 2184 mothers and infants were enrolled in the prospective cohort study (1070 mothers, 1114 infants). For in-facility observation, a separate 290 individuals (142 mothers, 148 infants) were enrolled. Denominators vary by baseline characteristic below. The other 3 cohorts did not have baseline data collected.
| Age, Continuous(Years) | Prospective Cohort Study - Quantitative | In-facility Observations | Total |
|---|---|---|---|
| Mean | 25.4 ± 5.3 | 26.5 ± 6.1 | 25.8 ± 5.4 |
| Sex: Female, Male(Participants) | Prospective Cohort Study - Quantitative | In-facility Observations | Total |
|---|---|---|---|
| Infant Sex — Female | 608 | 85 | 693 |
| Infant Sex — Male | 506 | 63 | 569 |
| Mothers sex — Female | 1070 | 142 | 1212 |
| Mothers sex — Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Prospective Cohort Study - Quantitative | In-facility Observations | Total |
|---|---|---|---|
| South Asian Infants | 506 | 73 | 579 |
| African Infants | 608 | 75 | 683 |
| South Asian Mothers | 497 | 72 | 569 |
| African Mothers | 573 | 70 | 643 |
| Region of Enrollment(Participants) | Prospective Cohort Study - Quantitative | In-facility Observations | Total |
|---|---|---|---|
| Malawi — Mothers | 273 | 35 | 308 |
| Malawi — Infants | 300 | 35 | 335 |
| Tanzania — Mothers | 300 | 35 | 335 |
| Tanzania — Infants | 308 | 40 | 348 |
| India — Mothers | 497 | 72 | 569 |
| India — Infants | 506 | 73 | 579 |
| Maternal Education(Participants) | Prospective Cohort Study - Quantitative | In-facility Observations | Total |
|---|---|---|---|
| Primary or less | 501 | 63 | 564 |
| Secondary or more | 569 | 79 | 648 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.
Supporting information: Study protocol, Icf
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Harvard School of Public Health (HSPH)