Optimizing Caffeine Dose for Better Breathing Support in Extremely Premature Infants Born Before 28 Weeks or Under 1000 Grams

What this Trial Is About

This research aims to determine if a higher dose of caffeine citrate can improve breathing and reduce serious health complications in extremely premature infants born before 28 weeks of pregnancy or weighing under 1000 grams. These infants often have difficulty breathing due to immature lungs, and caffeine is commonly used to support their respiratory function. The study compares the effects of a higher caffeine dose to the standard dose to find the safest and most effective treatment. Participants will be randomly assigned to one of two groups. One group will receive a high dose caffeine treatment starting with a 20 mgkg loading dose followed by a maintenance dose of 10 mgkg per day beginning at 7 days old, with possible dose increases up to 12.5 mgkg. The other group will receive the same loading dose but a standard maintenance dose of 5 mgkg per day, with possible increases to 7.5 mgkg. Caffeine will be given either intravenously or by mouth in a blinded manner. Treatment begins after infants regain their birth weight and continue until caffeine is stopped or hospital discharge. During the study, researchers will closely monitor oxygen levels using the Oxygen Saturation Index, respiratory support needs, growth, feeding progress, and any side effects such as fast heart rate or high blood pressure. They will also assess motor development before discharge using the Test of Infant Motor Performance. Participants will be followed from treatment start through discharge and up to one year for key health outcomes including lung disease, brain injury, and survival.

Caffeine Optimization for Oxygen Saturation Index in ELBW Infants