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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 1
Healthy Volunteers: f
View:

⁃ Preterm infants born \< 32 weeks' gestation may enroll at 34-44 weeks post-menstrual age, who:

• Remain on either invasive ventilation or non-invasive ventilation (continuous positive airway pressure or nasal intermittent positive pressure ventilation) for minimum 48 hours at the time of study entry. The minimum support required for inclusion is CPAP \> 5cm H2O or CPAP 5 with FiO2 \> 21%.

• 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.

Locations
United States
Massachusetts
Boston Children's Hospital
RECRUITING
Boston
Contact Information
Primary
Jonathan Levin, MD
jonathan.levin@childrens.harvard.edu
617-355-1900
Backup
Vanessa J Young, MS
vanessa.young@childrens.harvard.edu
617-355-8330
Time Frame
Start Date: 2024-10
Estimated Completion Date: 2026-02
Participants
Target number of participants: 50
Treatments
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.
Sponsors
Collaborators: Beth Israel Deaconess Medical Center
Leads: Boston Children's Hospital

This content was sourced from clinicaltrials.gov