Clinical trial NCT03646045: Transpyloric Feeding for Prevention of Micro-aspiration
Official title: Transpyloric Feeding for Prevention of Micro-aspiration
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Microaspiration
Gastro Esophageal Reflux
Lead sponsor: Nemours Children's Clinic
Sponsor class: OTHER
First posted: 2018-08-24
Enrollment: 46
Sex: ALL
Minimum age (years): 0
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm infants (birth weight \<1500 grams) requiring ventilator support.

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.

Eligibility criteria: Inclusion Criteria:

* Preterm infants with birth weight \<1500 grams
* Requiring ventilatory support

Exclusion Criteria:

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

Primary outcomes:
measure: Tracheal aspirate pepsin A levels in ventilated preterm infants receiving transpyloric feeding and gastric feeding.
timeFrame: 3-7 days
Secondary outcomes:
measure: Tracheal aspirate pepsin A levels in ventilated preterm infants before and after transpyloric feeding.
timeFrame: 3-7 days
measure: 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.
timeFrame: 3-7 days.
measure: 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.
timeFrame: 3-7 days
measure: Respiratory support in ventilated preterm infants receiving transpyloric feeding and gastric feeding.
timeFrame: 7-14 days
measure: Respiratory support in ventilated preterm infants before and transpyloric feeding.
timeFrame: 7-14 days
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: AI duPont Hospital for Children
state: Delaware
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
affiliation: Nemours
name: Zubair H Aghai, MD
role: PRINCIPAL_INVESTIGATOR
References: