Transpyloric Feeding for Prevention of Micro-aspiration

Gastro Esophageal Reflux Clinical Trial

Official title:

Transpyloric Feeding for Prevention of Micro-aspiration

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03646045
• Other study ID #: 741563-9
• Status: Active, not recruiting
• Start date: November 4, 2016
• Est. completion date: December 15, 2024

Study information

• Verified date: January 2024
• Source: Nemours Children's Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 46
• Est. completion date: December 15, 2024
• Est. primary completion date: May 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Months to 12 Months

Eligibility

Inclusion Criteria:

• Preterm infants with birth weight <1500 grams

• Requiring ventilatory support

Exclusion Criteria:

• Culture-proven sepsis

• Ventilator associated pneumonia (VAP).

Related Conditions & MeSH terms

• Gastro Esophageal Reflux
• Gastroesophageal Reflux
• Microaspiration

Intervention

Other:
• Transpyloric feeding
Preterm infant feeding using transpyloric feeding tube (nasoduodenal tube)

Locations

Country	Name	City	State
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	AI duPont Hospital for Children	Wilmington	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Nemours Children's Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Tracheal aspirate cytokines levels (TNF-a, IL-1ß, 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-a, IL-1ß, IL-6, IL-8, Ang2, HMGB1, MIF and IFN-gamma) in preterm ventilated infants receiving transpyloric feeding and gastric feeding.	3-7 days.
Secondary	Tracheal aspirate cytokines levels (TNF-a, IL-1ß, 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-a, IL-1ß, IL-6, IL-8, Ang2, HMGB1, MIF and IFN-gamma) in preterm ventilated infants before and after transpyloric feeding.	3-7 days
Secondary	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
Secondary	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