Feeding During Ibuprofen or Indomethacin Treatment of Preterm Infants
This study has been completed.
Sponsor:
University of California, San Francisco
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00728117
First received: July 31, 2008
Last updated: November 8, 2012
Last verified: November 2012
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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 |
Resource links provided by NLM:
Further study details as provided by University of California, San Francisco:
Primary Outcome Measures:
- 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). [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- incidence of necrotizing enterocolitis or spontaneous perforation [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
- Assess the effect of feeding very low birth weight infants during indomethacin or ibuprofen therapy on intestinal permeability. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
- Assess the effect of feeding very low birth weight infants during indomethacin or ibuprofen therapy on the normal hyperemic response to feeding. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
| Enrollment: | 177 |
| Study Start Date: | July 2008 |
| Study Completion Date: | September 2012 |
| 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
Detailed Description:
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 |
Criteria
Inclusion Criteria:
Infants between 401-1,250 g birth weight who
- Are receiving or are scheduled to begin enteral feedings and
- Are about to receive pharmacologic treatment (either indomethacin or ibuprofen) to close their PDA.
Exclusion Criteria:
- Serious congenital malformations
- Chromosomal anomalies
- Congenital or acquired gastrointestinal anomalies
- Prior episode of necrotizing enterocolitis
- Use of inotropic support for hypotension
- Renal anomalies or disease
- Are receiving > 80 ml/kg/d of enteral feeding
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00728117
Locations
| United States, California | |
| University of California san Francisco | |
| San Francisco, California, United States, 94143 | |
| Santa Clara Valley Medical Center | |
| San Jose, California, United States, 95128 | |
| United States, Illinois | |
| Children's Memorial Hospital-Northwestern University | |
| Chicago, Illinois, United States, 60614 | |
| North Shore University Health System, Northwestern University | |
| Evanston, Illinois, United States, 60201 | |
| United States, Massachusetts | |
| Boston University-Boston Medical Center | |
| Boston, Massachusetts, United States, 02118 | |
| United States, Minnesota | |
| Children's Hospital-Minneapolis | |
| Minneapolis, Minnesota, United States, 55404 | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 85359 | |
| Children's Hospital-Saint Paul | |
| Saint Paul, Minnesota, United States, 55102 | |
| United States, New Jersey | |
| Atlantic Health Organization | |
| Morristown, New Jersey, United States, 07962 | |
| United States, New York | |
| Columbia University | |
| New York, New York, United States, 10032 | |
| United States, Ohio | |
| Case Western Reserve | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Pennsylvania | |
| University of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15122 | |
| United States, Tennessee | |
| Vanderbilt University | |
| Nashville, Tennessee, United States, 37232 | |
| United States, Virginia | |
| University of Virginia, Charlottesville | |
| Charlottesville, Virginia, United States, 22908 | |
Sponsors and Collaborators
University of California, San Francisco
Investigators
| Principal Investigator: | Ronald Clyman, M.D. | University of California, San Francisco |
More Information
No publications provided
| Responsible Party: | 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: | November 8, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, San Francisco:
|
indomethacin ibuprofen preterm infant |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on May 19, 2013