Transpyloric Feeding for Prevention of Micro-aspiration

Nemours Children's Health

Status: Active, not recruiting

Conditions: Gastro Esophageal Reflux; Microaspiration

Treatments: Other: Transpyloric feeding

Study type: Observational

Funder types: Other

Identifiers

NCT03646045

741563-9

Details and patient eligibility

About

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

Full 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.

Enrollment: 46 patients

Sex: All

Ages: Under 12 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

46 participants in 2 patient groups

Transpyloric feed

Description:

Preterm infant receiving transpyloric feeding.

Treatment:

Other: Transpyloric feeding

Control

Description:

Preterm infants receiving gastric feeding