N/A
N=3,188
Low-birthweight Infant Feeding Exploration
Low Birthweight · Pre-Term
Bottom Line
View on ClinicalTrials.gov: NCT04002908 ↗Enrolled (actual)
3,188
Serious AEs
8.7%
Results posted
Apr 2025
Primary outcome: Primary: Length-for-Age Z-score — -1.43 Z-score
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- All
- Sponsor
- Harvard School of Public Health (HSPH)
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Length-for-Age Z-score |
-1.58 | — |
| PRIMARY Length-for-Age Z-score |
-1.58 | — |
| SECONDARY Incidence of Diarrheal Disease |
130 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04002908). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.