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NCT Number: NCT03646045

Transpyloric Feeding for Prevention of Micro-aspiration

To determine the effect of transpyloric (TP) feeding on microaspiration and lung inflammation in ventilated preterm infants.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Microaspiration Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastro Esophageal Reflux Gastroesophageal Reflux Gastrointestinal Diseases

Age range

0 month–12 month

Sex eligibility

All sexes

Study type

Observational

Primary location

AI duPont Hospital for Children, Wilmington, Delaware, United States

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About this study

Specific Aim 1): To determine the effect of TP feeding on microaspiration and lung inflammation. Hypothesis: TP feeding will reduce the microaspiration and pulmonary inflammation in ventilated preterm infants. Evaluate markers of microaspiration (pepsin A) and lung inflammation [total cell counts, nuclear factor-kB (NF-kB) activation, tumor necrosis factor-α (TNF-α), IL-1β, IL-6, IL-8, angiopoietin 2 (Ang2), high-mobility group box-1 protein (HMGB1), macrophage migration inhibitory factor (MIF) and interferon-γ (IFN-γ)] in TA samples obtained from preterm ventilated infants with and without TP feeding.

Specific Aim 2): To determine the effect of TP feeding on respiratory support. Hypothesis: TP feeding will decrease the respiratory severity score (RSS) [Fraction of inspired oxygen (FiO2) X mean airway pressure (MAP)] and number of infants requiring ventilator support. Evaluate respiratory support in preterm ventilated infants with and without TP feeding.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Preterm infants with birth weight <1500 grams
  • Requiring ventilatory support

Exclusion criteria

  • Culture-proven sepsis
  • Ventilator associated pneumonia (VAP).

Treatment and study plan

Transpyloric feeding

Other

Preterm infant feeding using transpyloric feeding tube (nasoduodenal tube)

Primary outcomes

  1. Tracheal aspirate pepsin A levels in ventilated preterm infants receiving transpyloric feeding and gastric feeding.

    Time frame: 3-7 days

    Difference in tracheal aspirate pepsin A levels in preterm ventilated infants receiving transpyloric feeding and gastric feeding.

Secondary outcomes

  1. Tracheal aspirate pepsin A levels in ventilated preterm infants before and after transpyloric feeding.

    Time frame: 3-7 days

    Change in tracheal aspirate pepsin A levels in preterm ventilated infants before and after transpyloric feeding.

  2. Tracheal aspirate cytokines levels (TNF-α, IL-1β, IL-6, IL-8, Ang2, HMGB1, MIF and IFN-gamma) in ventilated preterm infants receiving transpyloric feeding and gastric feeding.

    Time frame: 3-7 days.

    Difference in tracheal aspirate cytokines levels (TNF-α, IL-1β, IL-6, IL-8, Ang2, HMGB1, MIF and IFN-gamma) in preterm ventilated infants receiving transpyloric feeding and gastric feeding.

  3. Tracheal aspirate cytokines levels (TNF-α, IL-1β, IL-6, IL-8, Ang2, HMGB1, MIF and IFN-gamma) in ventilated preterm infants before and after transpyloric feeding.

    Time frame: 3-7 days

    Change in tracheal aspirate cytokines levels (TNF-α, IL-1β, IL-6, IL-8, Ang2, HMGB1, MIF and IFN-gamma) in preterm ventilated infants before and after transpyloric feeding.

  4. Respiratory support in ventilated preterm infants receiving transpyloric feeding and gastric feeding.

    Time frame: 7-14 days

    Difference in respiratory severity score (FiO2 X mean airway pressure) in preterm ventilated infants receiving transpyloric feeding and gastric feeding.

  5. Respiratory support in ventilated preterm infants before and transpyloric feeding.

    Time frame: 7-14 days

    Change in respiratory severity score (FiO2 X mean airway pressure) in preterm ventilated infants before and after transpyloric feeding.

Sponsors and collaborators

Lead sponsor

Nemours Children's Clinic

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2026
First posted
Aug 24, 2018
Registry last updated
Dec 24, 2025

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

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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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