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NCT Number: NCT06821776

Gastric Feeding Versus Transpyloric Feeding in Infants with Severe Bronchopulmonary Dysplasia, a Crossover Study

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.

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Key information

Conditions

Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Feeding Intolerance Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Respiratory Tract Diseases Ventilator-Induced Lung Injury

Age range

1 month–1 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gastric Feeding

Procedure

Subjects will be fed through a feeding tube that empties into the stomach.

Transpyloric feeding

Procedure

Subjects will be fed through a feeding tube that passes through the stomach and empties directly into the small intestine.

Primary outcomes

  1. Respiratory Severity Score (RSS)

    Time frame: 8 weeks

    RSS (the product of mean airway pressure and oxygen fraction) will be calculated before and after each 2-week intervention block.

Sponsors and collaborators

Lead sponsor

Le Bonheur Children's Hospital

Other

Registry information

Official study title

N-of-1 Trial Comparing Prolonged Gastric Feeding to Transpyloric Feeding in Infants with Severe Bronchopulmonary Dysplasia

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Feb 12, 2025
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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