The n-of-1 clinical trial: the ultimate strategy for individualizing medicine?
Elizabeth O Lillie, Bradley Patay, Joel Diamant...
https://pubmed.ncbi.nlm.nih.gov/21695041Actively Recruiting
Phase Not Applicable
Age: 1Month - 1Year
All Genders
ID06821776
N-of-1 Trial Comparing Prolonged Gastric Feeding to Transpyloric Feeding in Infants with Severe Bronchopulmonary Dysplasia
Led by Le Bonheur Children's Hospital · Updated on 2025-02-12
25
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating feeding methods for hospitalized infants with severe bronchopulmonary dysplasia (BPD) who also have feeding intolerance. This study aims to determine the best feeding approach by comparing continuous gastric feeding with continuous transpyloric feeding. The trial is designed as a randomized crossover study to assess respiratory status and identify the optimal feeding mode for each infant. Infants will receive two weeks of continuous gastric feeding through a tube placed in the stomach, followed by two weeks of continuous transpyloric feeding where the tube passes through the stomach into the small intestine. Each infant will experience both feeding methods in this crossover design, with a total of four weeks of feeding interventions. During the study, respiratory severity will be closely monitored using the Respiratory Severity Score over eight weeks. Participants will be assessed for respiratory status and feeding tolerance throughout the trial. The study is sponsored by Le Bonheur Children's Hospital and involves infants born before 32 weeks gestation currently admitted to the neonatal intensive care unit (NICU).
CONDITIONS
Brief Title
Gastric Feeding Versus Transpyloric Feeding in Infants with Severe Bronchopulmonary Dysplasia, a Crossover Study
Who Can Participate
Age: 1Month - 1Year
All Genders
Eligibility Criteria
You may qualify if you...
- Patients born <32 weeks' gestation
- Currently admitted to the Le Bonheur NICU
- Grade 2 or 3 bronchopulmonary dysplasia (positive pressure or intubated at 36 weeks postmenstrual age)
- Signs of gastroesophageal reflux, chronic aspiration, or other feeding intolerance
You will not qualify if you...
- Known gastrointestinal anomalies
- Unable to tolerate 60mL/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 less than 8 weeks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 4 weeks
Participants receive two feeding methods in a randomized order: gastric feeding and transpyloric feeding, each for 2 weeks.
2 feeding periods of 2 weeks each
Trial Site Locations
Total: 1 location
1
Le Bonheur Children's Hospital
Memphis, Tennessee, United States, 38103
Actively Recruiting
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Transpyloric feeding in severe BPD: a call for prospective trials.
Christopher D Baker, Deborah R Liptzin, Laurie C Eldredge
https://pubmed.ncbi.nlm.nih.gov/38431754Transpyloric feeding is associated with adverse in-hospital outcomes in infants with severe bronchopulmonary dysplasia.
Jonathan C Levin, Matthew J Kielt, Lystra P Hayden...
https://pubmed.ncbi.nlm.nih.gov/38218908Individualising care in severe bronchopulmonary dysplasia: a series of N-of-1 trials comparing transpyloric and gastric feeding.
Erik A Jensen, Huayan Zhang, Rui Feng...
https://pubmed.ncbi.nlm.nih.gov/31685527