Transpyloric Feeding for Prevention of Micro-aspiration

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

Study Overview

• Status: Active, not recruiting
• Conditions: Gastro Esophageal Reflux; Microaspiration
• Intervention / Treatment: Other: Transpyloric feeding

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 Type: Observational
• Enrollment (Actual): 46

Contacts and Locations

Study Locations

• United States
  • Delaware
    • Wilmington, Delaware, United States, 19803
      • AI duPont Hospital for Children
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Preterm infants (birth weight <1500 grams) requiring ventilator support.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Transpyloric feed; Preterm infant receiving transpyloric feeding.	Other: Transpyloric feeding; Preterm infant feeding using transpyloric feeding tube (nasoduodenal tube)
Control; Preterm infants receiving gastric feeding

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tracheal aspirate pepsin A levels in ventilated preterm infants receiving transpyloric feeding and gastric feeding.	Difference in tracheal aspirate pepsin A levels in preterm ventilated infants receiving transpyloric feeding and gastric feeding.	3-7 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nemours Children's Clinic
• Collaborators: Nemours Biomedical Research
• Investigators: Principal Investigator: Zubair H Aghai, MD, Nemours

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2016
• Primary Completion (Actual): May 30, 2018
• Study Completion (Estimated): December 15, 2026

Study Registration Dates

• First Submitted: July 30, 2018
• First Submitted That Met QC Criteria: August 22, 2018
• First Posted (Actual): August 24, 2018

Study Record Updates

• Last Update Posted (Estimated): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Gastroesophageal Reflux
• Other Study ID Numbers: 741563-9

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No