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We hypothesize that feeding preterm infants while they receive indomethacin or ibuprofen therapy for treatment of a patent ductus arteriosus will decrease the incidence of feeding intolerance and shorten the time period that infants need to tolerate full enteral nutrition. We also hypothesize that this intervention will minimize the alterations in intestinal permeability that occur with these drugs and will improve the infants' hemodynamic response to enteral nutrition
This study is a randomized controlled multi-center clinical trial to determine whether very low birth weight infants should receive feedings during indomethacin or ibuprofen treatment of a patent ductus arteriosus (PDA). Many neonatologists withhold feeds from premature infants receiving indomethacin or ibuprofen therapy for a PDA because of concerns that these drugs alter intestinal blood flow and permeability. However, there are no established studies which show that feeding during these medical treatments leads to bowel injury. At the same time, studies suggest that withholding feedings from premature infants may lead to intestinal atrophy and injury, leading to increased difficulty with feedings when they are initiated or re-started. Thus, this multi-center study evaluates whether feeding infants during indomethacin or ibuprofen therapy improves feeding tolerance by measuring the number of episodes of feeding intolerance and the number of days required to attain full feedings. In addition, this study will employ techniques to measure gastrointestinal permeability and mesenteric blood flow in patients who receive and don't receive feedings for their PDA treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ibuprofen-feeding | Experimental | Study infants will receive trophic enteral nutrition (15 ml/kg/day) during the study drug period.The study drug period is defined as the interval between administration of the first dose of ibuprofen and 24 hours after the last dose of ibuprofen. |
|
| ibuprofen-fasting | Experimental | Study infants will be fasted during the study drug period.The study drug period is defined as the interval between administration of the first dose of ibuprofen and 24 hours after the last dose of ibuprofen. |
|
| indomethacin-feeding | Experimental | Study infants will receive trophic enteral nutrition (15 ml/kg/day) during the study drug period.The study drug period is defined as the interval between administration of the first dose of indomethacin and 24 hours after the last dose of indomethacin. |
|
| indomethacin-fasting | Experimental | Study infants will be fasted during the study drug period.The study drug period is defined as the interval between administration of the first dose of indomethacin and 24 hours after the last dose of indomethacin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| feeding | Other | Study infants will receive trophic enteral nutrition (15 ml/kg/day) during the study drug period.The study drug period is defined as the interval between administration of the first dose of ibuprofen or indomethacin and 24 hours after the last dose of ibuprofen or indomethacin. |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the effect of feeding infants during indomethacin or ibuprofen therapy on the incidence of feeding intolerance and the number of days required to achieve full feedings (120 ml/kg/day). | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of necrotizing enterocolitis or spontaneous perforation | 4 years | |
| Assess the effect of feeding very low birth weight infants during indomethacin or ibuprofen therapy on intestinal permeability. | 4 years |
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Inclusion Criteria:
Infants between 401-1,250 g birth weight who
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald Clyman, M.D. | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California san Francisco | San Francisco | California | 94143 | United States | ||
| Santa Clara Valley Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24321538 | Derived | Yanowitz TD, Reese J, Gillam-Krakauer M, Cochran CM, Jegatheesan P, Lau J, Tran VT, Walsh M, Carey WA, Fujii A, Fabio A, Clyman R. Superior mesenteric artery blood flow velocities following medical treatment of a patent ductus arteriosus. J Pediatr. 2014 Mar;164(3):661-3. doi: 10.1016/j.jpeds.2013.11.002. Epub 2013 Dec 8. | |
| 23472765 |
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|
| fasting | Other | Study infants will be fasted during the study drug period.The study drug period is defined as the interval between administration of the first dose of ibuprofen or indomethacin and 24 hours after the last dose of ibuprofen or indomethacin. |
|
| Assess the effect of feeding very low birth weight infants during indomethacin or ibuprofen therapy on the normal hyperemic response to feeding. | 4 years |
| San Jose |
| California |
| 95128 |
| United States |
| Children's Memorial Hospital-Northwestern University | Chicago | Illinois | 60614 | United States |
| North Shore University Health System, Northwestern University | Evanston | Illinois | 60201 | United States |
| Boston University-Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| Children's Hospital-Minneapolis | Minneapolis | Minnesota | 55404 | United States |
| Mayo Clinic | Rochester | Minnesota | 85359 | United States |
| Children's Hospital-Saint Paul | Saint Paul | Minnesota | 55102 | United States |
| Atlantic Health Organization | Morristown | New Jersey | 07962 | United States |
| Columbia University | New York | New York | 10032 | United States |
| Case Western Reserve | Cleveland | Ohio | 44106 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15122 | United States |
| Vanderbilt University | Nashville | Tennessee | 37232 | United States |
| University of Virginia, Charlottesville | Charlottesville | Virginia | 22908 | United States |
| Clyman R, Wickremasinghe A, Jhaveri N, Hassinger DC, Attridge JT, Sanocka U, Polin R, Gillam-Krakauer M, Reese J, Mammel M, Couser R, Mulrooney N, Yanowitz TD, Derrick M, Jegatheesan P, Walsh M, Fujii A, Porta N, Carey WA, Swanson JR; Ductus Arteriosus Feed or Fast with Indomethacin or Ibuprofen (DAFFII) Investigators. Enteral feeding during indomethacin and ibuprofen treatment of a patent ductus arteriosus. J Pediatr. 2013 Aug;163(2):406-11. doi: 10.1016/j.jpeds.2013.01.057. Epub 2013 Mar 6. |
| ID | Term |
|---|---|
| D004374 | Ductus Arteriosus, Patent |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C407088 | Angptl4 protein, mouse |
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