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| Sponsor: | University of California, San Francisco |
|---|---|
| Information provided by: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00728117 |
Purpose
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
| Condition | Intervention |
|---|---|
|
Patent Ductus Arteriosus |
Other: feeding Other: fasting |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Should Very Low Birth Weight Infants Receive Enteral Nutrition During Indomethacin or Ibuprofen Treatment of a Patent Ductus Arteriosus? A Multi-Center Randomized Controlled Trial |
| Estimated Enrollment: | 400 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: ibuprofen-feeding
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.
|
Other: feeding
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.
|
|
No Intervention: ibuprofen-fasting
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.
|
Other: fasting
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.
|
|
Experimental: indomethacin-feeding
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.
|
Other: feeding
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.
|
|
No Intervention: indomethacin-fasting
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.
|
Other: fasting
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.
|
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.
Eligibility| Ages Eligible for Study: | 23 Weeks to 33 Weeks |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Infants between 401-1,250 g birth weight who
Exclusion Criteria:
Contacts and Locations| Contact: Ronald Clyman, M.D. | 415-476-4462 | clymanr@peds.ucsf.edu |
| United States, California | |
| University of California san Francisco | Recruiting |
| San Francisco, California, United States, 94143 | |
| Contact: Ronald Clyman, M.D. 415-476-4462 clymanr@peds.ucsf.edu | |
| Contact: Nami Jhaveri, M.D. JhaveriN@peds.ucsf.edu | |
| Principal Investigator: Ronald Clyman, M.D. | |
| Santa Clara Valley Medical Center | Recruiting |
| San Jose, California, United States, 95128 | |
| Contact: Priya Jegatheesan, M.D. 408-885-5423 Priya.Jegatheesan@hhs.co.santa-clara.ca.us | |
| Principal Investigator: Priya Jegatheesan, M.D. | |
| United States, Illinois | |
| Children's Memorial Hospital-Northwestern University | Recruiting |
| Chicago, Illinois, United States, 60614 | |
| Contact: Nic Porta, MD 773-880-3479 n-porta@northwestern.edu | |
| Principal Investigator: Nic Porta, MD | |
| North Shore University Health System, Northwestern University | Recruiting |
| Evanston, Illinois, United States, 60201 | |
| Contact: Mathew Derrick, MD 847-570-2920 mderrick@uchicago.edu | |
| Principal Investigator: Mathew Derrick, MD | |
| United States, Massachusetts | |
| Boston University-Boston Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02118 | |
| Contact: Alan Fujii, MD 617-414-3735 Alan.Fujii@bmc.org | |
| Principal Investigator: Alan Fujii, MD | |
| United States, Minnesota | |
| Children's Hospital-Minneapolis | Recruiting |
| Minneapolis, Minnesota, United States, 55404 | |
| Contact: Neil Mulrooney, MD 651-813-6288 Neil.Mulrooney@childrensmn.org | |
| Principal Investigator: Neil Mulrooney, MD | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States, 85359 | |
| Contact: William Carey, MD 507-284-7434 Carey.William@mayo.edu | |
| Principal Investigator: William Carey, MD | |
| Children's Hospital-Saint Paul | Recruiting |
| Saint Paul, Minnesota, United States, 55102 | |
| Contact: Mark Mammel, MD 651-220-6261 mamme001@tc.umn.edu | |
| Principal Investigator: Mark Mammel, MD | |
| United States, New Jersey | |
| Atlantic Health Organization | Recruiting |
| Morristown, New Jersey, United States, 07962 | |
| Contact: Denise Hassinger, MD 973-971-5488 Denise.hassinger@atlantichealth.org | |
| Principal Investigator: Denise Hassinger, MD | |
| United States, New York | |
| Columbia University | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Richard Polin, MD 917-495-7900 rap32@columbia.edu | |
| Principal Investigator: Richard Polin, MD | |
| Sub-Investigator: Ulana Sanocka, MD | |
| United States, Ohio | |
| Case Western Reserve | Recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Contact: Michele Walsh, MD 216-844-3759 Michele.Walsh@UHhospitals.org | |
| Principal Investigator: Michele Walsh, MD | |
| United States, Pennsylvania | |
| University of Pittsburgh | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15122 | |
| Contact: Toby Yanowitz, M.D. 412-641-6260 tyanowitz@mail.magee.edu | |
| Principal Investigator: Toby Yanowitz, M.D. | |
| United States, Tennessee | |
| Vanderbilt University | Recruiting |
| Nashville, Tennessee, United States, 37232 | |
| Contact: Jeff Reese, MD 615-322-8643 jeff.reese@vanderbilt.edu | |
| Principal Investigator: Jeff Reese, MD | |
| United States, Virginia | |
| University of Virginia, Charlottesville | Recruiting |
| Charlottesville, Virginia, United States, 22908 | |
| Contact: Josh Attridge, MD 434-924-2490 JA5U@hscmail.mcc.virginia.edu | |
| Principal Investigator: Josh Attridge, MD | |
| Principal Investigator: | Ronald Clyman, M.D. | University of California, San Francisco |
More Information
| Responsible Party: | Ronald Clyman, University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00728117 History of Changes |
| Other Study ID Numbers: | RC3 |
| Study First Received: | July 31, 2008 |
| Last Updated: | June 27, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
indomethacin ibuprofen preterm infant |
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Ductus Arteriosus, Patent Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Heart Diseases Congenital Abnormalities Ibuprofen Indomethacin Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents Gout Suppressants Tocolytic Agents Reproductive Control Agents Cardiovascular Agents |
