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

Bronchopulmonary Dysplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05777512
• Other study ID #: IRB-P00043302
• Status: Recruiting
• Phase: N/A
• Start date: October 2024
• Est. completion date: February 2026

Study information

• Verified date: November 2023
• Source: Boston Children's Hospital
• Contact: Jonathan Levin, MD
• Phone: 617-355-1900
• Email: jonathan.levin[@]childrens.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 2026
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Hours to 1 Year

Eligibility

Inclusion Criteria:

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

1. 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%.

2. Have ongoing need for respiratory support due to underlying lung disease from prematurity.

3. 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:

1. 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.

2. Infants who have other comorbidities that significantly contribute to lung disease, including cyanotic congenital heart disease, or other genetic, congenital, or pulmonary abnormalities.

3. Infants who were evaluated for necrotizing enterocolitis (including holding feedings) in the 7 days prior to study enrollment.

4. Infants with known gastrointestinal or airway malformations that would affect tolerance of feeds or the route of delivery of enteral feedings.

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia

Intervention

Procedure:
• Gastric Feeds
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
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.

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Children's Hospital	Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Respiratory Support Over the Course of the Study	The study team will monitor the patient's respiratory support needs by reviewing the medical record.	Over a 15 day period during study participation
Secondary	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.	Over a 15 day period during study participation