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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transpyloric feed | Preterm infant receiving transpyloric feeding. |
| |
| Control | Preterm infants receiving gastric feeding |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transpyloric feeding | Other | Preterm infant feeding using transpyloric feeding tube (nasoduodenal tube) |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Preterm infants (birth weight <1500 grams) requiring ventilator support.
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| Name | Affiliation | Role |
|---|---|---|
| Zubair H Aghai, MD | Nemours | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AI duPont Hospital for Children | Wilmington | Delaware | 19803 | United States | ||
| Thomas Jefferson University Hospital |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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Tracheal aspirate samples
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 |
| Philadelphia |
| Pennsylvania |
| 19107 |
| United States |
| D004066 | Digestive System Diseases |