Transpyloric Feeding for Prevention of Micro-aspiration
1 other identifier
observational
46
1 country
2
Brief Summary
To determine the effect of transpyloric (TP) feeding on microaspiration and lung inflammation in ventilated preterm infants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2016
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 4, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2018
CompletedFirst Submitted
Initial submission to the registry
July 30, 2018
CompletedFirst Posted
Study publicly available on registry
August 24, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2026
ExpectedDecember 24, 2025
December 1, 2025
1.6 years
July 30, 2018
December 17, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Tracheal aspirate pepsin A levels in ventilated preterm 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.
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.
3-7 days
Respiratory support in ventilated preterm infants receiving transpyloric feeding and gastric feeding.
7-14 days
Respiratory support in ventilated preterm infants before and transpyloric feeding.
7-14 days
Study Arms (2)
Transpyloric feed
Preterm infant receiving transpyloric feeding.
Control
Preterm infants receiving gastric feeding
Interventions
Preterm infant feeding using transpyloric feeding tube (nasoduodenal tube)
Eligibility Criteria
Preterm infants (birth weight \<1500 grams) requiring ventilator support.
You may qualify if:
- Preterm infants with birth weight \<1500 grams
- Requiring ventilatory support
You may not qualify if:
- Culture-proven sepsis
- Ventilator associated pneumonia (VAP).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
AI duPont Hospital for Children
Wilmington, Delaware, 19803, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Biospecimen
Tracheal aspirate samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zubair H Aghai, MD
Nemours
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Pediatrics
Study Record Dates
First Submitted
July 30, 2018
First Posted
August 24, 2018
Study Start
November 4, 2016
Primary Completion
May 30, 2018
Study Completion (Estimated)
December 15, 2026
Last Updated
December 24, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share