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

Primary Purpose

Bronchopulmonary Dysplasia

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gastric Feeds
Jejunal Feeds
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bronchopulmonary Dysplasia focused on measuring Chronic Lung Disease of Prematurity, Postpyloric Feeding, Nasojejunal Feeding, Bronchopulmonary Dysplasia, GERD, Gastro-esophageal Reflux

Eligibility Criteria

0 Hours - 1 Year (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Boston Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A: Gastric Followed by Jejunal Feeds

Group B: Jejunal Followed by Gastric Feeds

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in modified respiratory severity score (mRSS)
mRSS is a validated measurement for respiratory severity in chronic lung disease in neonates.
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.

Secondary Outcome Measures

Respiratory Support Over the Course of the Study
The study team will monitor the patient's respiratory support needs by reviewing the medical record.
Nutritional Status Over the Course of the Study
The study team will monitor the patient's nutritional status by reviewing the medical record at the end of each study period.

Full Information

First Posted
February 9, 2023
Last Updated
October 9, 2023
Sponsor
Boston Children's Hospital
Collaborators
Beth Israel Deaconess Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05777512
Brief Title
Randomized Controlled Crossover Trial of Postpyloric Feedings to Improve Pulmonary Outcomes in High-risk Preterm Infants
Official Title
A Randomized Controlled Crossover Trial of Postpyloric Versus Gastric Feedings to Improve Pulmonary Outcomes in High-risk Preterm Infants
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
February 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital
Collaborators
Beth Israel Deaconess Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Bronchopulmonary dysplasia (BPD) affects up to 50,000 preterm infants annually in the United States and is the most common complication of prematurity. Despite improving survival in preterm infants, incidence of BPD is increasing. Overall, 11% of infants are born preterm in the United States annually. While many outcomes of prematurity, including survival, have improved over time, the incidence of BPD has increased. Nearly all babies with BPD require provision of feeds via an enteral tube due to feeding immaturity and ongoing need for respiratory support, and up to ¼ of babies with the most severe forms of BPD require this long-term, and are discharged home with nasal or surgically placed feeding tubes. However, enteral feeding into the stomach frequently results in reflux in preterm infants. This may cause aspiration into the respiratory tract, which can result in further damage to the lungs and worsen respiratory outcomes. The study will measure the impact of NJ feedings on lung disease severity in a prospective crossover trial among infants at high-risk of developing BPD. Each randomized patient will participate in two blocks of feeding, a nasogastric (NG) and a nasojejunal (NJ, postpyloric) block. Subjects will be randomized to either the control (NG) or intervention (NJ) feedings in the first block. Outcomes will be compared pairwise by subject between the NG and NJ blocks. The findings of this study would be immediately impactful for neonatologists, pediatricians, pediatric pulmonologists, pediatric gastroenterologists, advanced practitioners, and nutritionists who determine nutritional strategies for preterm infants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchopulmonary Dysplasia
Keywords
Chronic Lung Disease of Prematurity, Postpyloric Feeding, Nasojejunal Feeding, Bronchopulmonary Dysplasia, GERD, Gastro-esophageal Reflux

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A: Gastric Followed by Jejunal Feeds
Arm Type
Experimental
Arm Description
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.
Arm Title
Group B: Jejunal Followed by Gastric Feeds
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Gastric Feeds
Other Intervention Name(s)
Nasogastric Feeding, NG feeds
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Jejunal Feeds
Other Intervention Name(s)
Nasojejunal Feeding, Postpyloric Feeding, NJ Feeds
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in modified respiratory severity score (mRSS)
Description
mRSS is a validated measurement for respiratory severity in chronic lung disease in neonates.
Time Frame
Over a 15 day period during study participation
Title
Tracheal Aspirates
Description
For infants who remain on invasive respiratory support, the study team will collect tracheal aspirates for the measurement of bile acid and pepsin concentration.
Time Frame
Over a 15 day period during study participation.
Secondary Outcome Measure Information:
Title
Respiratory Support Over the Course of the Study
Description
The study team will monitor the patient's respiratory support needs by reviewing the medical record.
Time Frame
Over a 15 day period during study participation
Title
Nutritional Status Over the Course of the Study
Description
The study team will monitor the patient's nutritional status by reviewing the medical record at the end of each study period.
Time Frame
Over a 15 day period during study participation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Hours
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan Levin, MD
Phone
617-355-1900
Email
jonathan.levin@childrens.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Vanessa J Young, MS
Phone
617-355-8330
Email
vanessa.young@childrens.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Levin, MD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Levin, MD
Phone
617-335-1900
Email
jonathan.levin@childrens.harvard.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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