Low-birthweight Infant Feeding Exploration

Pre-Term Clinical Trial

— LIFE  

Official title:

Low-birthweight Infant Feeding Exploration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04002908
• Other study ID #: HSPH OPP1192260
• Status: Completed
• Start date: July 31, 2019
• Est. completion date: July 29, 2021

Study information

• Verified date: May 2022
• Source: Harvard School of Public Health (HSPH)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1126
• Est. completion date: July 29, 2021
• Est. primary completion date: July 29, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 59 Years

Eligibility

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.

Exclusion criteria for the mother/infant pair are:

• Not previously enrolled in the LIFE study in addition to all original exclusion criteria.

Related Conditions & MeSH terms

• Birth Weight
• Low Birthweight
• Pre-Term

Locations

Country	Name	City	State
India	Jawaharlal Nehru Medical College	Belgaum
Malawi	UNC Project Malawi (UNCPM)	Lilongwe
Tanzania	Muhas/ Hsph	Dar Es Salaam

Sponsors (11)

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

Countries where clinical trial is conducted

India,  Malawi,  Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Weight-for-age z-score	Child's weight-for-age z-score (kg)	At 6 month of age; at 12 month of age.
Other	Percentage of children who are nutritionally at risk in first 12 months of life	Using a combination of traditional anthropometric measures we will define children who don't meet expected growth standards.	0-12 months of age.
Primary	Length-for-Age z-score	A Child's length-for-age z-score (cm) at 6 months of age	At 6 month of ag
Secondary	Incidence of Infant Morbidity	Maternal Report of Diarrheal Disease, Pneumonia, Sepsis, Malaria, Necrotizing Entercolitis, Seizures, Hyperbilirubinemia	6 month postpartum;12 month postpartum