Clinical trial NCT00728117: Feeding During Ibuprofen or Indomethacin Treatment of Preterm Infants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patent Ductus Arteriosus
Keywords: indomethacin
ibuprofen
preterm infant
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2008-08-05
Enrollment: 177
Sex: ALL
Minimum age (years): 23
Maximum age (years): 33
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: 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).
timeFrame: 4 years
Secondary outcomes:
measure: incidence of necrotizing enterocolitis or spontaneous perforation
timeFrame: 4 years
measure: Assess the effect of feeding very low birth weight infants during indomethacin or ibuprofen therapy on intestinal permeability.
timeFrame: 4 years
measure: Assess the effect of feeding very low birth weight infants during indomethacin or ibuprofen therapy on the normal hyperemic response to feeding.
timeFrame: 4 years
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California san Francisco
state: California
city: San Jose
country: United States
facility: Santa Clara Valley Medical Center
state: California
city: Chicago
country: United States
facility: Children's Memorial Hospital-Northwestern University
state: Illinois
city: Evanston
country: United States
facility: North Shore University Health System, Northwestern University
state: Illinois
city: Boston
country: United States
facility: Boston University-Boston Medical Center
state: Massachusetts
city: Minneapolis
country: United States
facility: Children's Hospital-Minneapolis
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Paul
country: United States
facility: Children's Hospital-Saint Paul
state: Minnesota
city: Morristown
country: United States
facility: Atlantic Health Organization
state: New Jersey
city: New York
country: United States
facility: Columbia University
state: New York
city: Cleveland
country: United States
facility: Case Western Reserve
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Charlottesville
country: United States
facility: University of Virginia, Charlottesville
state: Virginia
Study officials:
affiliation: University of California, San Francisco
name: Ronald Clyman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Clyman 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.