NCT06821776

Brief 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. Respiratory status will be assessed to determine the optimal feeding mode for each infant.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
46mo left

Started Feb 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Feb 2025Feb 2030

Study Start

First participant enrolled

February 5, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 6, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 12, 2025

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2030

Last Updated

February 12, 2025

Status Verified

February 1, 2025

Enrollment Period

5 years

First QC Date

February 6, 2025

Last Update Submit

February 6, 2025

Conditions

Bronchopulmonary DysplasiaFeeding Intolerance

Keywords

BPD

Outcome Measures

Primary Outcomes (1)

  • 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.

    8 weeks

Study Arms (2)

Gastric feeding

ACTIVE COMPARATOR

Subject will receive 2 weeks of continuous gastric feeding via a feeding tube in the stomach.

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.

Procedure: Transpyloric feeding

Interventions

Gastric feedingPROCEDURE

Subjects will be fed through a feeding tube that empties into the stomach.

Gastric feeding
Transpyloric feedingPROCEDURE

Subjects will be fed through a feeding tube that passes through the stomach and empties directly into the small intestine.

Transpyloric feeding

Eligibility Criteria

Age1 Month - 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Le Bonheur Children's Hospital

Memphis, Tennessee, 38103, United States

RECRUITING

Related Publications (4)

  • 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.

    PMID: 21695041BACKGROUND

  • Baker 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.

    PMID: 38431754BACKGROUND

  • Levin 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.

    PMID: 38218908BACKGROUND

  • Jensen 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.

    PMID: 31685527BACKGROUND

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Interventions

Enteral Nutrition

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung InjuryLung InjuryLung DiseasesRespiratory Tract DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Feeding MethodsTherapeuticsNutritional SupportNutrition Therapy

Study Officials

  • Mark Weems, MD

    University of Tennessee

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2025

First Posted

February 12, 2025

Study Start

February 5, 2025

Primary Completion (Estimated)

February 1, 2030

Study Completion (Estimated)

February 1, 2030

Last Updated

February 12, 2025

Record last verified: 2025-02

Locations

US(1)