Clinical trials

This is a research study to compare an investigational infant formula against a currently marketed infant formula. An investigational infant formula is one that has never been approved by the United States Food and Drug Administration (FDA). The purpose of this research study is to evaluate the growth and tolerance of infants who consume a new (not yet available to buy) extensively hydrolyzed cow milk protein infant formula compared to an extensively hydrolyzed cow milk protein infant formula that is currently available to buy. The study will also look at the growth of your baby, how many poops your baby has, what the poops are like (for example, soft or hard), how much study formula your baby drinks, how well your baby handles the study formula (such as spit-up, fussiness, gas, colic, or changes in sleep), and any health problems that might come up during the study.

The goal of this observational study is to examine national trends in mode of delivery and to assess associations between cesarean section and early-life health outcomes using routinely collected health data in Thailand. The study includes mother-infant dyads delivering in public hospitals across Thailand. The main questions it aims to answer are: Is cesarean delivery associated with increased risk of adverse neonatal outcomes compared with vaginal delivery? Is cesarean delivery associated with differences in early-life healthcare utilization and breastfeeding outcomes during the first year of life? Researchers will compare infants born by cesarean section with infants born by vaginal delivery to evaluate differences in neonatal morbidity, healthcare utilization, and breastfeeding patterns. Participants will not receive any intervention. The study involves secondary analysis of de-identified national health administrative and clinical data, including delivery records and linked maternal and infant health outcomes.