Randomized Controlled Crossover Trial of Postpyloric Feedings to Improve Pulmonary Outcomes in High-risk Preterm Infants

NCT05777512 | Recruiting DMC

• 1 other identifier: IRB-P00043302
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if postpyloric feedings effectively improve objective measures of pulmonary health in preterm infants with chronic lung disease when compared with nasogastric (NG) feedings. This research will (1) determine the optimal nutritional management to prevent a common and costly complication of prematurity, and (2) use a novel crossover design that examines outcomes of clinical endpoints alongside biomarkers.

Conditions

Bronchopulmonary Dysplasia

Keywords

Chronic Lung Disease of Prematurity; Postpyloric Feeding; Nasojejunal Feeding; Bronchopulmonary Dysplasia; GERD; Gastro-esophageal Reflux

Outcome Measures

Primary Outcomes (2)

• Change in modified respiratory severity score (mRSS)

  mRSS is a validated measurement for respiratory severity in chronic lung disease in neonates.

  Over a 15 day period during study participation

• Tracheal Aspirates

  For infants who remain on invasive respiratory support, the study team will collect tracheal aspirates for the measurement of bile acid and pepsin concentration.

  Over a 15 day period during study participation.

Secondary Outcomes (2)

• Respiratory Support Over the Course of the Study

  Over a 15 day period during study participation

• Nutritional Status Over the Course of the Study

  Over a 15 day period during study participation

Study Arms (2)

Group A: Gastric Followed by Jejunal Feeds

EXPERIMENTAL

Participants randomized into this group will begin with one ten-day block of nasogastric (NG) feeds followed by one ten-day block of nasojejunal (NJ, postpyloric) feeds.

Procedure: Gastric Feeds; Procedure: Jejunal Feeds

Group B: Jejunal Followed by Gastric Feeds

EXPERIMENTAL

Participants randomized into this group will begin with one ten-day block of nasojejunal (NJ, postpyloric) feeds followed by one ten-day block of nasogastric (NG) feeds.

Procedure: Gastric Feeds; Procedure: Jejunal Feeds

Interventions

Gastric Feeds PROCEDURE

The participant will receive nutrition via a nasogastric tube. Gastric feedings will be administered as bolus feeds every 3 hours over 1 hour. Infants who are deemed able to advance oral feedings via mouth during the study period will be permitted to do so, and this will be recorded.

Also known as: Nasogastric Feeding, NG feeds

Group A: Gastric Followed by Jejunal Feeds; Group B: Jejunal Followed by Gastric Feeds

Jejunal Feeds PROCEDURE

The participant will receive nutrition via a nasojejunal tube. Postpyloric feedings will be administered continuously into the jejunum. Infants who are deemed able to advance oral feedings via mouth during the study period will be permitted to do so, and this will be recorded.

Also known as: Nasojejunal Feeding, Postpyloric Feeding, NJ Feeds

Group A: Gastric Followed by Jejunal Feeds; Group B: Jejunal Followed by Gastric Feeds

Eligibility Criteria

• Age: 0 Hours - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infants born \< 32 weeks' gestation may enroll at 34-44 weeks post-menstrual age, who:
• Have ongoing need for respiratory support due to underlying lung disease from prematurity.
• Are tolerating \> 80 ml/kg/day of enteral feedings at baseline, either via nasogastric (NG) or nasojejunal (NJ) tube. Patients may be receiving gastric (NG) or postpyloric (NJ) feedings.

You may not qualify if:

• Infants who are transiently on respiratory support at the time of study entry due to another reason than underlying lung disease from prematurity; for example, recovery from a surgical intervention.
• Infants who have other comorbidities that significantly contribute to lung disease, including cyanotic congenital heart disease, or other genetic, congenital, or pulmonary abnormalities.
• Infants who were evaluated for necrotizing enterocolitis (including holding feedings) in the 7 days prior to study enrollment.
• Infants with known gastrointestinal or airway malformations that would affect tolerance of feeds or the route of delivery of enteral feedings.

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Beth Israel Deaconess Medical Center: collaborator

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Jonathan Levin, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Levin, MD

CONTACT

617-355-1900; jonathan.levin@childrens.harvard.edu

Vanessa J Young, MS

CONTACT

617-355-8330; vanessa.young@childrens.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor of Pediatrics

Model Details: This is a randomized single crossover study design, with each of two 10-day study blocks. Infants will be individually randomized to the study intervention (jejunal feeding) in Block 1 or Block 2. The first 48 hours of each study block will be considered run-in/washout periods.

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: March 21, 2023
• Study Start: October 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: February 1, 2026
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)