MicroaspirationNCT03646045
Transpyloric Feeding for Prevention of Micro-aspiration
An observational study of Microaspiration and Gastro Esophageal Reflux, run by Nemours Children's Clinic at 2 sites in United States.
Trial summary
To determine the effect of transpyloric (TP) feeding on microaspiration and lung inflammation in ventilated preterm infants. Read more about this study
- Who is it for?
- Ages 0 to 12 months
- Conditions the study is for
- Microaspiration, Gastro Esophageal Reflux
- What is being tested?
- Transpyloric feeding
- How many people
- 46 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Nov 2016to 15 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 12 months
- All sexes
- No healthy volunteers
- Child
Study population: Preterm infants (birth weight <1500 grams) requiring ventilator support.
Who may be able to join
- Preterm infants with birth weight <1500 grams
- Requiring ventilatory support
Who cannot join
- Culture-proven sepsis
- Ventilator associated pneumonia (VAP).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
AI duPont Hospital for Children
Wilmington, Delaware, 19803
About this study
To determine the effect of transpyloric (TP) feeding on microaspiration and lung inflammation in ventilated preterm infants.
Read the 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.
- Conditions
- Microaspiration, Gastro Esophageal Reflux
- Being tested
- Transpyloric feeding
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transpyloric feedingOther
Preterm infant feeding using transpyloric feeding tube (nasoduodenal tube)
| Study group | Role | What they receive |
|---|---|---|
| Transpyloric feed | Preterm infant receiving transpyloric feeding. Receives: Other: Transpyloric feeding | |
| Control | Preterm infants receiving gastric feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-7 days
Secondary outcomes (5)
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.
Measured: 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.
Difference in tracheal aspirate cytokines levels (TNF-α, IL-1β, IL-6, IL-8, Ang2, HMGB1, MIF and IFN-gamma) in preterm ventilated infants receiving transpyloric feeding and gastric feeding.
Measured: 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.
Change in tracheal aspirate cytokines levels (TNF-α, IL-1β, IL-6, IL-8, Ang2, HMGB1, MIF and IFN-gamma) in preterm ventilated infants before and after transpyloric feeding.
Measured: 3-7 days
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.
Measured: 7-14 days
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.
Measured: 7-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start4 Nov 2016
- Primary completion30 May 2018
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicroaspirationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zubair Aghai, Nemours Children's Clinic
- Investigators
- Zubair H Aghai, MD, Principal investigator, Nemours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03646045
- Sponsor's protocol ID
- 741563-9
- Status last verified
- Dec 2025
- First submitted
- 30 Jul 2018
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transpyloric Feeding for Prevention of Micro-aspiration
- ClinicalTrials.gov ID
- NCT03646045
- Acronym / sponsor ID
- 741563-9
- Conditions
- Microaspiration, Gastro Esophageal Reflux
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Study start
- 4 Nov 2016 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 24 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transpyloric feed | – | Other: Transpyloric feedingPreterm infant receiving transpyloric feeding. |
| Control | – | –Preterm infants receiving gastric feeding |
Who may qualify
- Ages
- 0 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm infants (birth weight <1500 grams) requiring ventilator support.
Key inclusion criteria (2 listed)
- Preterm infants with birth weight <1500 grams
- Requiring ventilatory support
Key exclusion criteria (2 listed)
- Culture-proven sepsis
- Ventilator associated pneumonia (VAP).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transpyloric feedingPreterm infant feeding using transpyloric feeding tube (nasoduodenal tube) | Other | Transpyloric feed |
Primary outcome
Tracheal aspirate pepsin A levels in ventilated preterm infants receiving transpyloric feeding and gastric feeding.
Time frame: 3-7 days
Difference in tracheal aspirate pepsin A levels in preterm ventilated infants receiving transpyloric feeding and gastric feeding.
5 secondary outcomes
Tracheal aspirate pepsin A levels in ventilated preterm infants before and after transpyloric feeding.
Time frame: 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.
Time frame: 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.
Time frame: 3-7 days
Respiratory support in ventilated preterm infants receiving transpyloric feeding and gastric feeding.
Time frame: 7-14 days
Respiratory support in ventilated preterm infants before and transpyloric feeding.
Time frame: 7-14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: No
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Intraabdominal Hypertension and Occurrence of Microaspiration in Cirrhotics Under Mechanical Ventilation
Critical Illness, Cirrhosis, Liver
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Deflated and Inflated Cuff Endotracheal Extubations
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zubair H Aghai, MD principal investigator
Nemours
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microaspiration and Gastro Esophageal Reflux, run by Nemours Children's Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tracheal aspirate pepsin A levels in ventilated preterm infants receiving transpyloric feeding and gastric feeding. (time frame: 3-7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.