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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston Children's Hospital
Study ID
NCT05777512
Status
Recruiting
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Conditions

  • Bronchopulmonary Dysplasia

Eligibility Criteria

Sex
ALL
Age
0 Hours - 1 Year
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Apr 26, 2024
Status verified
Jun 2026
Primary completion
Sep 30, 2027
Completion
Feb 29, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Group A: Gastric Followed by Jejunal Feeds
    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.
  • Experimental: Group B: Jejunal Followed by Gastric Feeds
    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.

Primary Outcome Measure

Change in modified respiratory severity score (mRSS) [ Time Frame: Over a 15 day period during study participation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Children's HospitalBostonMassachusetts02115
Jonathan Levin, MD
[email protected]
617-335-1900

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By research site
Boston Children's Hospital· Boston, MA

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