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Low-birthweight Infant Feeding Exploration

Low-birthweight Infant Feeding Exploration

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04002908
Acronym
LIFE
Enrollment
3188
Registered
2019-07-01
Start date
2019-07-31
Completion date
2021-07-29
Last updated
2025-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Birthweight, Pre-Term

Keywords

Infant Health, Low and Middle Income Countries [LMIC], Maternal Health, Infant Feeding, Low Birthweight

Brief 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). 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: 1. Understand the current practices and standard of care (SOC) for feeding LBW infants 2. Define and document the key outcomes (including growth, morbidity, and lack of success on MOM) for LBW infants under current practices 3. 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.

Interventions

None listed

Sponsors

Bill and Melinda Gates Foundation
CollaboratorOTHER
Emory University
CollaboratorOTHER
Boston Children's Hospital
CollaboratorOTHER
Brigham and Women's Hospital
CollaboratorOTHER
PATH
CollaboratorOTHER
University of North Carolina, Chapel Hill
CollaboratorOTHER
Jawaharlal Nehru Medical College
CollaboratorOTHER
Muhimbili University of Health and Allied Sciences
CollaboratorOTHER
University of North Carolina
CollaboratorOTHER
Ariadne Labs
CollaboratorOTHER
Harvard School of Public Health (HSPH)
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to 59 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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. * 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: Inclusion criteria for the mother/infant pair are: * 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.

Design outcomes

Primary

MeasureTime frameDescription
Length-for-Age Z-scoreAt 6 month of ageA 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.

Secondary

MeasureTime frameDescription
Incidence of Diarrheal Disease6 month postpartumMaternal Report of Ever having Diarrheal Disease from weeks 1 to 6 months of age

Other

MeasureTime frameDescription
Weight-for-age Z-scoreAt 6 month of ageChild'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.
Percentage of Infants Malnourished at 6 Months6 months of ageInfants 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.
Percentage of Infants Malnourished at 12 Months12 months of ageInfants 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.

Countries

India, Malawi, Tanzania

Participant flow

Pre-assignment details

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.

Participants by arm

ArmCount
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.
2,184
In-facility Observations
Moderately low birthweight (1500 to \< 2500g) infants and their mothers were enrolled during their admission to the postnatal ward or neonatal intensive care unit.
290
Total2,474

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyDeath41000
Overall StudyInfant died, so mother withdrawn34000
Overall StudyLost to Follow-up72000
Overall StudyWithdrawal by Subject112000

Baseline characteristics

CharacteristicTotalProspective Cohort Study - QuantitativeIn-facility Observations
Age, Continuous25.8 Years
STANDARD_DEVIATION 5.4
25.4 Years
STANDARD_DEVIATION 5.3
26.5 Years
STANDARD_DEVIATION 6.1
Maternal Education
Primary or less
564 Participants501 Participants63 Participants
Maternal Education
Secondary or more
648 Participants569 Participants79 Participants
Race/Ethnicity, Customized
African Infants
683 Participants608 Participants75 Participants
Race/Ethnicity, Customized
African Mothers
643 Participants573 Participants70 Participants
Race/Ethnicity, Customized
South Asian Infants
579 Participants506 Participants73 Participants
Race/Ethnicity, Customized
South Asian Mothers
569 Participants497 Participants72 Participants
Region of Enrollment
India
Infants
579 Participants506 Participants73 Participants
Region of Enrollment
India
Mothers
569 Participants497 Participants72 Participants
Region of Enrollment
Malawi
Infants
335 Participants300 Participants35 Participants
Region of Enrollment
Malawi
Mothers
308 Participants273 Participants35 Participants
Region of Enrollment
Tanzania
Infants
348 Participants308 Participants40 Participants
Region of Enrollment
Tanzania
Mothers
335 Participants300 Participants35 Participants
Sex: Female, Male
Infant Sex
Female
693 Participants608 Participants85 Participants
Sex: Female, Male
Infant Sex
Male
569 Participants506 Participants63 Participants
Sex: Female, Male
Mothers sex
Female
1212 Participants1070 Participants142 Participants
Sex: Female, Male
Mothers sex
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
37 / 1,1144 / 1,0703 / 142
other
Total, other adverse events
0 / 1,1140 / 1,0700 / 142
serious
Total, serious adverse events
172 / 1,11422 / 1,0708 / 142

Outcome results

Primary

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

Population: Low birth weight infants; This outcome was only collected on the quantitative prospective cohort population.

ArmMeasureValue (MEAN)Dispersion
Prospective Cohort Study - QuantitativeLength-for-Age Z-score-1.58 Z-scoreStandard Deviation 1.21
Primary

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

Population: Low birth weight infants. This outcome was only collected on the quantitative prospective cohort population.

ArmMeasureValue (MEAN)Dispersion
Prospective Cohort Study - QuantitativeLength-for-Age Z-score-1.43 Z-scoreStandard Deviation 1.28
Secondary

Incidence of Diarrheal Disease

Maternal Report of Ever having Diarrheal Disease from weeks 1 to 6 months of age

Time frame: 6 month postpartum

Population: Low Birth Weight Infants; This outcome was only collected on the quantitative prospective cohort population.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Prospective Cohort Study - QuantitativeIncidence of Diarrheal Disease130 Participants
Other Pre-specified

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

Population: Low birth weight infants

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Prospective Cohort Study - QuantitativePercentage of Infants Malnourished at 12 Months518 Participants
Other Pre-specified

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

Population: Low birth weight infants; This outcome was only collected on the quantitative prospective cohort population.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Prospective Cohort Study - QuantitativePercentage of Infants Malnourished at 6 Months373 Participants
Other Pre-specified

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

Population: Low Birth Weight Infants; This outcome was only collected on the quantitative prospective cohort population.

ArmMeasureValue (MEAN)Dispersion
Prospective Cohort Study - QuantitativeWeight-for-age Z-score-1.28 Z-scoreStandard Deviation 1.12
Other Pre-specified

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

Population: Low Birth Weight Infants; This outcome was only collected on the quantitative prospective cohort population.

ArmMeasureValue (MEAN)Dispersion
Prospective Cohort Study - QuantitativeWeight-for-age Z-score-1.23 Z-scoreStandard Deviation 1.2

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026