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| Name | Class |
|---|---|
| Beth Israel Deaconess Medical Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Gastric Followed by Jejunal Feeds | Experimental | 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. |
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| Group B: Jejunal Followed by Gastric Feeds | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Nutritional Status Over the Course of the Study |
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Inclusion Criteria:
Preterm infants born < 32 weeks' gestation may enroll at 34-44 weeks post-menstrual age, who:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Levin, MD | Contact | 617-355-1900 | jonathan.levin@childrens.harvard.edu | |
| Vanessa J Young, MS | Contact | 617-355-8330 | vanessa.young@childrens.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jonathan Levin, MD | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
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| ID | Term |
|---|---|
| D001997 | Bronchopulmonary Dysplasia |
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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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.
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| 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. |
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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 |
| D007235 |
| Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |