Transpyloric Feeding for Prevention of Micro-aspiration

Active, not recruiting

• Conditions: Microaspiration; Gastro Esophageal Reflux
• Interventions: Other: Transpyloric feeding

• Registration Number: NCT03646045
• Lead Sponsor: Nemours Children's Clinic

Brief 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.

Study Timeline

• Study Start: 2016-11-04
• Primary Completion: 2018-05-30
• Study First Submitted: 2018-07-30
• Study First Submitted QC: 2018-08-22
• Study First Posted: 2018-08-24
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-04
• Last Update Posted: 2024-07-08
• Study Completion: 2024-12-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Transpyloric feed	Transpyloric feeding	Preterm infant receiving transpyloric feeding.

Primary Outcome Measures

Name	Time	Method
Tracheal aspirate pepsin A levels in ventilated preterm infants receiving transpyloric feeding and gastric feeding.	3-7 days	Difference in tracheal aspirate pepsin A levels in preterm ventilated infants receiving transpyloric feeding and gastric feeding.

Secondary Outcome Measures

Name	Time	Method
Respiratory support in ventilated preterm infants before and transpyloric feeding.	7-14 days	Change in respiratory severity score (FiO2 X mean airway pressure) in preterm ventilated infants before and after transpyloric feeding.
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.	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.
Tracheal aspirate pepsin A levels in ventilated preterm infants before and after transpyloric feeding.	3-7 days	Change in tracheal aspirate pepsin A levels in preterm ventilated infants before and after transpyloric feeding.
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.	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.
Respiratory support in ventilated preterm infants receiving transpyloric feeding and gastric feeding.	7-14 days	Difference in respiratory severity score (FiO2 X mean airway pressure) in preterm ventilated infants receiving transpyloric feeding and gastric feeding.

Trial Locations

Locations (2)

Thomas Jefferson University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

AI duPont Hospital for Children; 🇺🇸 Wilmington, Delaware, United States