Gastro Esophageal Reflux, Microaspiration
Conditions
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.
Interventions
OTHERTranspyloric feeding
Preterm infant feeding using transpyloric feeding tube (nasoduodenal tube)
Sponsors
Nemours Children's Clinic
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Months to 12 Months
Healthy volunteers
No
Inclusion criteria
* Preterm infants with birth weight \<1500 grams * Requiring ventilatory support
Exclusion criteria
* Culture-proven sepsis * Ventilator associated pneumonia (VAP).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Outcome results
None listed