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
1 other identifier
interventional
177
1 country
14
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2008
Longer than P75 for not_applicable
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 31, 2008
CompletedFirst Posted
Study publicly available on registry
August 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedNovember 9, 2012
November 1, 2012
4 years
July 31, 2008
November 8, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (3)
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
Assess the effect of feeding very low birth weight infants during indomethacin or ibuprofen therapy on the normal hyperemic response to feeding.
4 years
Study Arms (4)
ibuprofen-feeding
EXPERIMENTALStudy 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
EXPERIMENTALStudy 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
EXPERIMENTALStudy 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
EXPERIMENTALStudy 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
University of California san Francisco
San Francisco, California, 94143, United States
Santa Clara Valley Medical Center
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
Related Publications (2)
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.
PMID: 24321538DERIVEDClyman 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.
PMID: 23472765DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ronald Clyman, M.D.
University of California, San Francisco
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2008
First Posted
August 5, 2008
Study Start
July 1, 2008
Primary Completion
July 1, 2012
Study Completion
September 1, 2012
Last Updated
November 9, 2012
Record last verified: 2012-11