Transpyloric Feeding for Prevention of Micro-aspiration

N/AActive Not RecruitingNCT03646045

Nemours Children's Clinic46 enrolled

Overview

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

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

Conditions

Microaspiration Gastro Esophageal Reflux

Interventions

Transpyloric feedingOTHER

Preterm infant feeding using transpyloric feeding tube (nasoduodenal tube)

Eligibility

Sex: ALLMin age: 0 MonthsMax age: 12 Months

Medical Language ↔ Plain English

Inclusion Criteria: * Preterm infants with birth weight \<1500 grams * Requiring ventilatory support Exclusion Criteria: * Culture-proven sepsis * Ventilator associated pneumonia (VAP).

Locations (2)

AI duPont Hospital for Children

Wilmington, Delaware, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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.

Time frame: 3-7 days

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 7-14 days

Respiratory support in ventilated preterm infants before and transpyloric feeding.

Data from ClinicalTrials.gov

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