July 31, 2008 |
February 12, 2009 |
July 2008 |
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 ] |
Same as current |
Complete list of historical versions of study NCT00728117 on ClinicalTrials.gov Archive Site |
- 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 ]
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Same as current |
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Feeding During Ibuprofen or Indomethacin Treatment of Preterm Infants |
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 |
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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Interventional |
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Patent Ductus Arteriosus |
- Other: feeding
- Other: fasting
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- 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.
- 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.
- 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.
- 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.
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Recruiting |
400 |
July 2012 |
July 2012 (final data collection date for primary outcome measure) |
Inclusion Criteria:
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
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Both |
23 Weeks to 30 Weeks |
No |
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United States |
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NCT00728117 |
Ronald Clyman, University of California, San Francisco |
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University of California, San Francisco |
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Principal Investigator: |
Ronald Clyman, M.D. |
University of California, San Francisco |
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University of California, San Francisco |
February 2009 |