NCT03646045

Transpyloric Feeding for Prevention of Micro-aspiration

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 46 (actual)
• Sponsor: Nemours Children's Clinic · Academic / Other
• Sex: All
• Age: 0 Months – 12 Months
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Microaspiration
• Gastro Esophageal Reflux

Interventions

Type	Name	Description
OTHER	Transpyloric feeding	Preterm infant feeding using transpyloric feeding tube (nasoduodenal tube)

Timeline

• Start date: 2016-11-04
• Primary completion: 2018-05-30
• Completion: 2026-12-15
• First posted: 2018-08-24
• Last updated: 2025-12-24

Locations

2 sites across 1 country: United States