Feeding During Ibuprofen or Indomethacin Treatment of Preterm Infants

Patent Ductus Arteriosus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00728117
• Other study ID #: RC3
• Status: Completed
• Phase: N/A
• First received: July 31, 2008
• Last updated: November 8, 2012
• Start date: July 2008
• Est. completion date: September 2012

Study information

• Verified date: November 2012
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 177
• Est. completion date: September 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 23 Weeks to 33 Weeks

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ductus Arteriosus, Patent
• Patent Ductus Arteriosus

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Boston University-Boston Medical Center	Boston	Massachusetts
United States	University of Virginia, Charlottesville	Charlottesville	Virginia
United States	Children's Memorial Hospital-Northwestern University	Chicago	Illinois
United States	Case Western Reserve	Cleveland	Ohio
United States	North Shore University Health System, Northwestern University	Evanston	Illinois
United States	Children's Hospital-Minneapolis	Minneapolis	Minnesota
United States	Atlantic Health Organization	Morristown	New Jersey
United States	Vanderbilt University	Nashville	Tennessee
United States	Columbia University	New York	New York
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	Children's Hospital-Saint Paul	Saint Paul	Minnesota
United States	University of California san Francisco	San Francisco	California
United States	Santa Clara Valley Medical Center	San Jose	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	incidence of necrotizing enterocolitis or spontaneous perforation		4 years	Yes
Secondary	Assess the effect of feeding very low birth weight infants during indomethacin or ibuprofen therapy on intestinal permeability.		4 years	No
Secondary	Assess the effect of feeding very low birth weight infants during indomethacin or ibuprofen therapy on the normal hyperemic response to feeding.		4 years	No