Gastric Feeding Versus Transpyloric Feeding in Infants with Severe Bronchopulmonary Dysplasia, a Crossover Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Gastric feeding, Transpyloric feeding.
- Who it may be relevant to
- Registry conditions: Bronchopulmonary Dysplasia, Feeding Intolerance. Basic parameters: 1 months — 1 year · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
N-of-1 Trial Comparing Prolonged Gastric Feeding to Transpyloric Feeding in Infants with Severe Bronchopulmonary Dysplasia
Overview
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.
Interventions
- Procedure Gastric feeding
Subjects will be fed through a feeding tube that empties into the stomach. - Procedure Transpyloric feeding
Subjects will be fed through a feeding tube that passes through the stomach and empties directly into the small intestine.
Primary outcome measures
- Respiratory Severity Score (RSS) [Time frame: 8 weeks]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
- Expected to remain hospitalized <8 weeks
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Le Bonheur Children's Hospital — Memphis
Publications
- 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. PMID 21695041
- 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. PMID 38431754
- 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. PMID 38218908
- 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. PMID 31685527
Identifiers
NCT: NCT06821776 · 24-10394-FB