Gastric Feeding Versus Transpyloric Feeding in Infants with Severe Bronchopulmonary Dysplasia, a Crossover Study
NCT ID: NCT06821776
Last Updated: 2025-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
25 participants
INTERVENTIONAL
2025-02-05
2030-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Gastric feeding
Subject will receive 2 weeks of continuous gastric feeding via a feeding tube in the stomach.
Gastric feeding
Subjects will be fed through a feeding tube that empties into the stomach.
Transpyloric feeding
Subject will receive 2 weeks of continuous transypyloric feeding via a feeding tube that passes through the stomach into the first portion of the small intestine.
Transpyloric feeding
Subjects will be fed through a feeding tube that passes through the stomach and empties directly into the small intestine.
Interventions
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Gastric feeding
Subjects will be fed through a feeding tube that empties into the stomach.
Transpyloric feeding
Subjects will be fed through a feeding tube that passes through the stomach and empties directly into the small intestine.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
* Expected to remain hospitalized \<8 weeks
1 Month
1 Year
ALL
No
Sponsors
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Le Bonheur Children's Hospital
OTHER
Responsible Party
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Principal Investigators
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Mark Weems, MD
Role: PRINCIPAL_INVESTIGATOR
University of Tennessee
Locations
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Le Bonheur Children's Hospital
Memphis, Tennessee, United States
Countries
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Facility Contacts
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Mark Weems, MD
Role: backup
References
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Lillie EO, Patay B, Diamant J, Issell B, Topol EJ, Schork NJ. The n-of-1 clinical trial: the ultimate strategy for individualizing medicine? Per Med. 2011 Mar;8(2):161-173. doi: 10.2217/pme.11.7.
Baker CD, Liptzin DR, Eldredge LC. Transpyloric feeding in severe BPD: a call for prospective trials. J Perinatol. 2024 Jul;44(7):1079. doi: 10.1038/s41372-024-01919-1. Epub 2024 Mar 2. No abstract available.
Levin JC, Kielt MJ, Hayden LP, Conroy S, Truog WE, Guaman MC, Abman SH, Nelin LD, Rosen RL, Leeman KT. Transpyloric feeding is associated with adverse in-hospital outcomes in infants with severe bronchopulmonary dysplasia. J Perinatol. 2024 Feb;44(2):307-313. doi: 10.1038/s41372-024-01867-w. Epub 2024 Jan 13.
Jensen EA, Zhang H, Feng R, Dysart K, Nilan K, Munson DA, Kirpalani H. Individualising care in severe bronchopulmonary dysplasia: a series of N-of-1 trials comparing transpyloric and gastric feeding. Arch Dis Child Fetal Neonatal Ed. 2020 Jul;105(4):399-404. doi: 10.1136/archdischild-2019-317148. Epub 2019 Nov 4.
Other Identifiers
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24-10394-FB
Identifier Type: -
Identifier Source: org_study_id
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