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| Sponsored by: |
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: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
|---|---|
|
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.
|
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.
|
|
ibuprofen-fasting: No Intervention
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.
|
|
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.
|
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.
|
|
indomethacin-fasting: No Intervention
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 30 Weeks |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Infants between 401-1,250 g birth weight (delivered between 23 and 1/7 - 30 and 6/7 weeks gestation) who
Exclusion Criteria:
Contacts and Locations| Contact: Ronald Clyman, M.D. | 415-476-4462 | clymanr@peds.ucsf.edu |
| Contact: Nami Jhaveri, M.D. | JhaveriN@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, 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. | |
| Principal Investigator: | Ronald Clyman, M.D. | University of California, San Francisco |
More Information
| Responsible Party: | University of California, San Francisco ( Ronald Clyman ) |
| Study ID Numbers: | RC3 |
| Study First Received: | July 31, 2008 |
| Last Updated: | August 4, 2008 |
| ClinicalTrials.gov Identifier: | NCT00728117 |
| Health Authority: | United States: Institutional Review Board |
|
indomethacin ibuprofen preterm infant |
|
Body Weight Birth Weight Ibuprofen Heart Diseases Cardiovascular Abnormalities |
Indomethacin Patent ductus arteriosus Congenital Abnormalities Heart Defects, Congenital Ductus Arteriosus, Patent |
|
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Cardiovascular Agents Reproductive Control Agents Gout Suppressants Pharmacologic Actions Tocolytic Agents |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Cardiovascular Diseases Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |
