MedDataX Logo

Transpyloric Feeding for Prevention of Micro-aspiration

NCT ID: NCT03646045

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-04

Study Completion Date

2026-12-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Microaspiration Gastro Esophageal Reflux

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Transpyloric feed

Preterm infant receiving transpyloric feeding.

Transpyloric feeding

Intervention Type OTHER

Preterm infant feeding using transpyloric feeding tube (nasoduodenal tube)

Control

Preterm infants receiving gastric feeding

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Transpyloric feeding

Preterm infant feeding using transpyloric feeding tube (nasoduodenal tube)

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

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

0 Months

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Nemours Children's Clinic

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Zubair Aghai

Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Zubair H Aghai, MD

Role: PRINCIPAL_INVESTIGATOR

Nemours

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

AI duPont Hospital for Children

Wilmington, Delaware, United States

Site Status

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

741563-9

Identifier Type: -

Identifier Source: org_study_id