India, Malawi, Tanzania3,188 participantsStarted 2019-07-31
Plain-language 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.
Who can participate
Age range16 Years – 59 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …