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/21695041/Actively Recruiting
Led by Le Bonheur Children's Hospital · Updated on 2025-02-12
25
Participants Needed
1
Research Sites
N/A
Total Duration
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 Childrens Hospital and involves infants born before 32 weeks gestation currently admitted to the neonatal intensive care unit NICU.
CONDITIONS
Gastric Feeding Versus Transpyloric Feeding in Infants with Severe Bronchopulmonary Dysplasia, a Crossover Study
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Le Bonheur Children's Hospital
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Gastric tube feeding (into the stomach) | Transpyloric tube feeding (into the small intestine) |
|---|---|---|
| What it is | A tube feeding method where nutrition is delivered directly into the stomach using a feeding tube. | A tube feeding method where the feeding tube is advanced past the stomach (pylorus) to deliver nutrition into the small intestine. |
| Role in trial | One of the two assigned feeding techniques evaluated for infants with severe BPD and feeding intolerance. | The alternate assigned feeding technique used for comparison within the same infants. |
| Primary use | Delivering nutrition directly to the stomach in infants with severe BPD and symptoms such as gastroesophageal reflux or feeding intolerance. | Delivering nutrition directly to the small intestine for infants with severe BPD to try to bypass the stomach and potentially reduce aspiration or reflux. |
| How it is given or performed | A feeding tube is inserted so it empties into the infant’s stomach. Feeds are delivered through the tube as per protocol. | The feeding tube is advanced through the stomach and into the small intestine, delivering nutrition past the pylorus. |
| Evidence status | Widely used feeding approach in neonatal care for infants with BPD and feeding intolerance. Considered routine and supported by clinical practice, but with limited prospective comparative data specific to severe BPD. | Used in selected infants to reduce aspiration and reflux; however, recent analyses found no consistent benefit and some studies report higher risk of adverse in-hospital outcomes (e.g., feeding complications) compared with gastric feeding. |
| Important limitations | May be associated with greater risk of reflux or aspiration in some infants, especially those with severe cardiorespiratory problems or intolerance. High-quality comparative data in severe BPD is limited. | Associated with potential risks such as tube misplacement, feeding intolerance, and possibly higher rates of in-hospital complications compared to gastric feeding. Evidence quality is affected by observational nature and potential selection bias. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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Lead Sponsor