4.1. Principal Findings
weight gain, abdominal distention
ADVERSE EVENTS, RECRUITMENT
In this prematurely terminated randomized controlled trial, we did not find any statistically significant difference in the velocity of weight gain during the supplementation period in infants born before 32 weeks of gestation who received TF compared to those who received SF. Changes in length and head circumference did not differ between the groups.We ceased recruitment due to five cases of intolerance to feeds in the TF group, such as significant abdominal distention (reported in two consecutive measurements), regurgitation, and posseting. These adverse events were reported to the local bioethical committee according to the study protocol, and the researchers decided to terminate the trial [