Clinical trial NCT05777512: 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
Overall status: RECRUITING
Phase: NA
Conditions: Bronchopulmonary Dysplasia
Keywords: Chronic Lung Disease of Prematurity
Postpyloric Feeding
Nasojejunal Feeding
Bronchopulmonary Dysplasia
GERD
Gastro-esophageal Reflux
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Beth Israel Deaconess Medical Center
First posted: 2023-03-21
Enrollment: 50
Sex: ALL
Minimum age (years): 0
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in modified respiratory severity score (mRSS)
timeFrame: Over a 15 day period during study participation
measure: Tracheal Aspirates
timeFrame: Over a 15 day period during study participation.
Secondary outcomes:
measure: Respiratory Support Over the Course of the Study
timeFrame: Over a 15 day period during study participation
measure: Nutritional Status Over the Course of the Study
timeFrame: Over a 15 day period during study participation
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Jonathan Levin, MD
role: PRINCIPAL_INVESTIGATOR
References: