Gastric Feeding Versus Transpyloric Feeding in Infants with Severe Bronchopulmonary Dysplasia, a Crossover Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-1
SponsorLe Bonheur Children's Hospital
About this trial
Hospitalized infants with severe bronchopulmonary dysplasia (BPD) and feeding intolerance will be randomized to 2 weeks of continuous gastric feeding or continuous transpyoloric feeding. Subjects will crossover after 2 weeks and receive 4 weeks of each feeding mode. Respiratory status will be assessed to determine the optimal feeding mode for each infant.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients born <32 weeks' gestation
Currently admitted to the Le Bonheur NICU
Grad 2 or 3 BPD (positive pressure or intubated at 36 weeks PMA)
Signs of gastroesophageal reflux, chronic aspiration, or other feeding intolerance.
Disqualifiers
Known gastrointestinal anomalies
Unable to tolerate ≥100mL/kg/day enteral feeding
Congenital anomalies likely to alter feeding techniques
Surgical feeding tube in place or expected within the next 8 weeks
Trial design
Design model
Crossover
Treatments tested in this trial
Gastric feeding
Procedure/SurgerySubjects will be fed through a feeding tube that empties into the stomach.
Transpyloric feeding
Procedure/SurgerySubjects will be fed through a feeding tube that passes through the stomach and empties directly into the small intestine.
Treatment groups
25 Participants
are divided into 2 treatment groupsGroup A: Gastric feedingActive comparator 1 intervention
Group B: Transpyloric feedingActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Respiratory Severity Score (RSS)
RSS (the product of mean airway pressure and oxygen fraction) will be calculated before and after each 2-week intervention block.
Time frame
8 weeksSponsors and contacts
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Source ClinicalTrials.gov