Transpyloric Versus Gastric Feeding for Infants with Bronchopulmonary Dysplasia
This study is looking at two ways to feed infants born prematurely who have bronchopulmonary dysplasia (a chronic lung condition) and gastroesophageal reflux (GER, when stomach contents come back up into the esophagus). Researchers want to see if feeding directly into the small intestine (transpyloric tube feeding) is better than feeding into the stomach (gastric tube feeding) at reducing GER. They will also check if one feeding method leads to less time with low oxygen levels in the blood (hypoxemia) or fewer serious problems. The study aims to enroll 60 infants between 1 and 12 months old who meet specific criteria related to their birth and lung condition. The current status of the study is unclear.
- Study design
- This is an interventional study comparing two feeding methods, transpyloric tube feeding and gastric tube feeding, in 60 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Serious adverse events will be measured until hospital discharge.
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Transpyloric Versus Gastric Feeding in Bronchopulmonary Dysplasia
At a glance
Conditions
Where it's being run
4 sites across 4 statesWho to contact
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What this trial measures
- Proportion (%) of time per day with oxygen saturation <80%During the 2 week trial
Oxygen saturation will be measured by continuous pulse oximetry throughout the 2 week trial. The proportion of time per day with an oxygen saturation (SpO2) less than 80% will be calculated and reported as a median value observed over the 2 week trial.
- Serious adverse eventsUntil hospital discharge
A serious adverse event (SAE) will be defined as any adverse experience that is at least possibly related to the study intervention and results in any of the following outcomes: * death, * a life-threatening event (at risk of death at the time of the event), * prolongation of existing hospitalization beyond what would be expected for a preterm infant who requires extended respiratory support near and beyond term corrected gestation, or * a persistent or significant disability/incapacity.