Transpyloric Feeding for Prevention of Micro-aspiration

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

Detailed Description
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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.

Official Title
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Transpyloric Feeding for Prevention of Micro-aspiration

Conditions
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Microaspiration, Gastro Esophageal Reflux

Intervention / Treatment
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* Other: Transpyloric feeding


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

Ages Eligible for Study
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Minimum Age: 0 Months
Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Transpyloric feed<br>Preterm infant receiving transpyloric feeding. | Other: Transpyloric feeding<br>* Preterm infant feeding using transpyloric feeding tube (nasoduodenal tube)<br>|
| Control<br>Preterm infants receiving gastric feeding | |

What is the study measuring?
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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 |