Bronchopulmonary DysplasiaNCT06821776
Gastric Feeding Versus Transpyloric Feeding in Infants with Severe Bronchopulmonary Dysplasia, a Crossover Study
A study testing Gastric feeding and Transpyloric feeding in people with Bronchopulmonary Dysplasia and Feeding Intolerance, run by Le Bonheur Children's Hospital at 1 site in United States.
Trial summary
Hospitalized infants with severe bronchopulmonary dysplasia (BPD) and feeding intolerance will be randomized to 2 weeks of continuous gastric feeding or continuous transpyoloric feeding. Subjects will crossover after 2 weeks and receive 4 weeks of each feeding mode. Read more about this study
- Who is it for?
- Ages 1 month to 1 year
- Conditions the study is for
- Bronchopulmonary Dysplasia, Feeding Intolerance
- What is being tested?
- Gastric feeding and Transpyloric feeding
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2025to Feb 2030
- Phase
- Interventional
- 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 1 month to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients born <32 weeks' gestation
- Currently admitted to the Le Bonheur NICU
- Grad 2 or 3 BPD (positive pressure or intubated at 36 weeks PMA)
- Signs of gastroesophageal reflux, chronic aspiration, or other feeding intolerance.
Who cannot join
- Known gastrointestinal anomalies
- Unable to tolerate ≥100mL/kg/day enteral feeding
- Congenital anomalies likely to alter feeding techniques
- Surgical feeding tube in place or expected within the next 8 weeks
- Expected to remain hospitalized <8 weeks
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Le Bonheur Children's Hospital
Memphis, Tennessee, 38103
Mark Weems, MD, 901-448-8400, mweems@uthsc.edu
Katie Williams, 901-287-8400, kathryn.williams@lebonheur.org
About this study
Official title: N-of-1 Trial Comparing Prolonged Gastric Feeding to Transpyloric Feeding in Infants with Severe Bronchopulmonary Dysplasia
Hospitalized infants with severe bronchopulmonary dysplasia (BPD) and feeding intolerance will be randomized to 2 weeks of continuous gastric feeding or continuous transpyoloric feeding. Subjects will crossover after 2 weeks and receive 4 weeks of each feeding mode. Respiratory status will be assessed to determine the optimal feeding mode for each infant.
- Conditions
- Bronchopulmonary Dysplasia, Feeding Intolerance
- Being tested
- Gastric feeding, Transpyloric feeding
- Keywords
- BPD
- Medical subject headings
- Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric feedingProcedure or surgery
Subjects will be fed through a feeding tube that empties into the stomach.
Transpyloric feedingProcedure or surgery
Subjects will be fed through a feeding tube that passes through the stomach and empties directly into the small intestine.
| Study group | Role | What they receive |
|---|---|---|
| Gastric feeding | Active comparator | Subject will receive 2 weeks of continuous gastric feeding via a feeding tube in the stomach. Receives: Procedure: Gastric feeding |
| Transpyloric feeding | Active comparator | Subject will receive 2 weeks of continuous transypyloric feeding via a feeding tube that passes through the stomach into the first portion of the small intestine. Receives: Procedure: Transpyloric feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Severity Score (RSS)
RSS (the product of mean airway pressure and oxygen fraction) will be calculated before and after each 2-week intervention block.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start5 Feb 2025
- Primary completionFeb 2030 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Bronchopulmonary DysplasiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Le Bonheur Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Weems, MD, Principal investigator, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06821776
- Sponsor's protocol ID
- 24-10394-FB
- Status last verified
- Feb 2025
- First submitted
- 6 Feb 2025
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lillie EO, Patay B, Diamant J, Issell B, Topol EJ, Schork NJ. The n-of-1 clinical trial: the ultimate strategy for individualizing medicine? Per Med. 2011 Mar;8(2):161-173. doi: 10.2217/pme.11.7.
PubMed 21695041Baker CD, Liptzin DR, Eldredge LC. Transpyloric feeding in severe BPD: a call for prospective trials. J Perinatol. 2024 Jul;44(7):1079. doi: 10.1038/s41372-024-01919-1. Epub 2024 Mar 2. No abstract available.
PubMed 38431754Levin JC, Kielt MJ, Hayden LP, Conroy S, Truog WE, Guaman MC, Abman SH, Nelin LD, Rosen RL, Leeman KT. Transpyloric feeding is associated with adverse in-hospital outcomes in infants with severe bronchopulmonary dysplasia. J Perinatol. 2024 Feb;44(2):307-313. doi: 10.1038/s41372-024-01867-w. Epub 2024 Jan 13.
PubMed 38218908Jensen EA, Zhang H, Feng R, Dysart K, Nilan K, Munson DA, Kirpalani H. Individualising care in severe bronchopulmonary dysplasia: a series of N-of-1 trials comparing transpyloric and gastric feeding. Arch Dis Child Fetal Neonatal Ed. 2020 Jul;105(4):399-404. doi: 10.1136/archdischild-2019-317148. Epub 2019 Nov 4.
PubMed 31685527
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- N-of-1 Trial Comparing Prolonged Gastric Feeding to Transpyloric Feeding in Infants with Severe Bronchopulmonary Dysplasia
- ClinicalTrials.gov ID
- NCT06821776
- Acronym / sponsor ID
- 24-10394-FB
- Conditions
- Bronchopulmonary Dysplasia, Feeding Intolerance
- Keywords
- BPD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Le Bonheur Children's HospitalUniversity, hospital or other
- Study start
- 5 Feb 2025 (actual)
- Primary completion
- Feb 2030 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 12 Feb 2025 (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.
Hospitalized infants with severe bronchopulmonary dysplasia (BPD) and feeding intolerance will be randomized to 2 weeks of continuous gastric feeding or continuous transpyoloric feeding. Subjects will crossover after 2 weeks and receive 4 weeks of each feeding mode. Respiratory status will be assessed to determine the optimal feeding mode for each infant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastric feeding | Active comparator | Procedure: Gastric feedingSubject will receive 2 weeks of continuous gastric feeding via a feeding tube in the stomach. |
| Transpyloric feeding | Active comparator | Procedure: Transpyloric feedingSubject will receive 2 weeks of continuous transypyloric feeding via a feeding tube that passes through the stomach into the first portion of the small intestine. |
Who may qualify
- Ages
- 1 month to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients born <32 weeks' gestation
- Currently admitted to the Le Bonheur NICU
- Grad 2 or 3 BPD (positive pressure or intubated at 36 weeks PMA)
- Signs of gastroesophageal reflux, chronic aspiration, or other feeding intolerance.
Key exclusion criteria (5 listed)
- Known gastrointestinal anomalies
- Unable to tolerate ≥100mL/kg/day enteral feeding
- Congenital anomalies likely to alter feeding techniques
- Surgical feeding tube in place or expected within the next 8 weeks
- Expected to remain hospitalized <8 weeks
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 |
|---|---|---|
| Gastric feedingSubjects will be fed through a feeding tube that empties into the stomach. | Procedure or surgery | Gastric feeding |
| Transpyloric feedingSubjects will be fed through a feeding tube that passes through the stomach and empties directly into the small intestine. | Procedure or surgery | Transpyloric feeding |
Primary outcome
Respiratory Severity Score (RSS)
Time frame: 8 weeks
RSS (the product of mean airway pressure and oxygen fraction) will be calculated before and after each 2-week intervention block.
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 12 Feb 2025.
- Background: PubMed 21695041Lillie EO, Patay B, Diamant J, Issell B, Topol EJ, Schork NJ. The n-of-1 clinical trial: the ultimate strategy for individualizing medicine? Per Med. 2011 Mar;8(2):161-173. doi: 10.2217/pme.11.7.
- Background: PubMed 38431754Baker CD, Liptzin DR, Eldredge LC. Transpyloric feeding in severe BPD: a call for prospective trials. J Perinatol. 2024 Jul;44(7):1079. doi: 10.1038/s41372-024-01919-1. Epub 2024 Mar 2. No abstract available.
- Background: PubMed 38218908Levin JC, Kielt MJ, Hayden LP, Conroy S, Truog WE, Guaman MC, Abman SH, Nelin LD, Rosen RL, Leeman KT. Transpyloric feeding is associated with adverse in-hospital outcomes in infants with severe bronchopulmonary dysplasia. J Perinatol. 2024 Feb;44(2):307-313. doi: 10.1038/s41372-024-01867-w. Epub 2024 Jan 13.
- Background: PubMed 31685527Jensen EA, Zhang H, Feng R, Dysart K, Nilan K, Munson DA, Kirpalani H. Individualising care in severe bronchopulmonary dysplasia: a series of N-of-1 trials comparing transpyloric and gastric feeding. Arch Dis Child Fetal Neonatal Ed. 2020 Jul;105(4):399-404. doi: 10.1136/archdischild-2019-317148. Epub 2019 Nov 4.
- Individual participant dataSharing planned: Undecided
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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.
Mark Weems, MD principal investigator
University of Tennessee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastric feeding and Transpyloric feeding in people with Bronchopulmonary Dysplasia and Feeding Intolerance, run by Le Bonheur Children's Hospital at 1 site 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory Severity Score (RSS) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06821776, which also lists 4 linked publications.
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 12 Feb 2025.