Infant Malnutrition clinical trials

DEUX OEUFs: Cracking the Potential of Eggs to Improve Child Growth and Development

This proposed randomized controlled trial aims to investigate the effect of maternal egg consumption during pregnancy on birth length. The study hypothesizes that mothers who consume two eggs a day will have children whose birth length is significantly longer than those born to mothers who consume a typical diet. Pregnant women (n=956) from Nyagatare District in Rwanda will be randomized into one of two study arms: a treatment group (T1) or a control group (T2). Mothers in the treatment arm will receive an animal source food (ASF) supplement of two eggs per day, from enrollment during first trimester through childbirth. Mothers in the control arm will be asked to continue consuming their typical diet. Mothers in both arms will receive standard information, education, and communication about health and nutrition during pregnancy and after birth. All enrolled mothers in the study will also receive up- to-date standard care for pregnant women, as outlined by the Government of Rwanda, a fortified blended flour if they are not already receiving it from the government, a mobile phone with cellular connection, health insurance if they do not already have, and compensation for traveling to a Community Health Worker's home every day for study engagement. All women will receive ultrasound examinations three times during pregnancy, as well as blood tests for anemia. Women in the control arm will receive additional compensation at childbirth. Women will be recruited and enrolled during first trimester (9-14 weeks gestational age), as confirmed by ultrasound. At enrollment, baseline data will be collected on socio-economic factors, maternal health, maternal diet, and fetal growth. Additional markers for maternal health and child growth and development, including markers for fetal brain development, will be collected during two targeted ante-natal clinic visits (20-26 weeks and 30-34 weeks), where all women will receive ultrasound assessment in addition to their typical clinical assessment. At childbirth, maternal and child health data will be collected, including birth outcomes, child anthropometry, and indicators of neurodevelopment. Additional follow-up of maternal and child health indicators, including maternal depression, and infant and young child feeding practices, will be collected at 1 month and 6 months of child age.