Feeding During Ibuprofen or Indomethacin Treatment of Preterm Infants

Condition(s) targeted: Patent Ductus Arteriosus

Intervention: feeding (Other); fasting (Other)

Phase: N/A

Status: Recruiting

Sponsored by: University of California, San Francisco

Official(s) and/or principal investigator(s):
Ronald Clyman, M.D., Principal Investigator, Affiliation: University of California, San Francisco

Overall contact:
Ronald Clyman, M.D., Phone: 415-476-4462, Email: clymanr@peds.ucsf.edu

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

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 design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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).

Secondary outcome:

incidence of necrotizing enterocolitis or spontaneous perforation

Assess the effect of feeding very low birth weight infants during indomethacin or ibuprofen therapy on intestinal permeability.

Assess the effect of feeding very low birth weight infants during indomethacin or ibuprofen therapy on the normal hyperemic response to feeding.

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.

Minimum age: 23 Weeks. Maximum age: 33 Weeks. Gender(s): Both.

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

Ronald Clyman, M.D., Phone: 415-476-4462, Email: clymanr@peds.ucsf.edu

University of California san Francisco, San Francisco, California 94143, United States; Recruiting
Ronald Clyman, M.D., Phone: 415-476-4462, Email: clymanr@peds.ucsf.edu
Nami Jhaveri, M.D., Email: JhaveriN@peds.ucsf.edu
Ronald Clyman, M.D., Principal Investigator

Santa Clara Valley Medical Center, San Jose, California 95128, United States; Recruiting
Priya Jegatheesan, M.D., Phone: 408-885-5423, Email: Priya.Jegatheesan@hhs.co.santa-clara.ca.us
Priya Jegatheesan, M.D., Principal Investigator

San Jose Pediatrix Medical Group, San Jose, California 95124., United States; Recruiting
Meera Sankar, MD, Phone: 408-377-8100, Email: Meera_Sankar@pediatrix.com
Meera Sankar, MD, Principal Investigator

Alta Bates Summit Medical Center, Oakland, California, United States; Recruiting
Golde Dudell, MD, Phone: 510-567-0111, Email: ggdmd@earthlink.net
Golde Dudell, MD, Principal Investigator

Loma Linda University, Loma Linda, California, United States; Recruiting
Doug Deming, MD, Phone: 909-558-7448, Email: DDeming@llu.edu
Douglas Deming, MD, Principal Investigator

North Shore University Health System, Northwestern University, Evanston, Illinois 60201, United States; Recruiting
Mathew Derrick, MD, Phone: 847-570-2920, Email: mderrick@uchicago.edu
Mathew Derrick, MD, Principal Investigator

Children's Memorial Hospital-Northwestern University, Chicago, Illinois, United States; Recruiting
Nic Porta, MD, Phone: 773-880-3479, Email: n-porta@northwestern.edu
Nic Porta, MD, Principal Investigator

Boston University-Boston Medical Center, Boston, Massachusetts 02118, United States; Recruiting
Alan Fujii, MD, Phone: 617-414-3735, Email: Alan.Fujii@bmc.org
Alan Fujii, MD, Principal Investigator

Children's Hospital-Minneapolis, Minneapolis, Minnesota 55404, United States; Recruiting
Bob Couser, MD, Phone: 651-247-4774, Email: couse0011@comcast.net
Bob Couser, MD, Principal Investigator

Children's Hospital-Saint Paul, Saint Paul, Minnesota 55102, United States; Recruiting
Mark Mammel, MD, Phone: 651-220-6261, Email: mamme001@tc.umn.edu
Mark Mammel, MD, Principal Investigator

Mayo Clinic, Rochester, Minnesota, United States; Recruiting
William Carey, MD, Phone: 507-284-7434, Email: Carey.William@mayo.edu
William Carey, MD, Principal Investigator

Atlantic Health Organization, Morristown, New Jersey, United States; Recruiting
Denise Hassinger, MD, Phone: 973-971-5488, Email: Denise.hassinger@atlantichealth.org
Denise Hassinger, MD, Principal Investigator

Columbia University, New York, New York, United States; Recruiting
Richard Polin, MD, Phone: 917-495-7900, Email: rap32@columbia.edu
Richard Polin, MD, Principal Investigator

Case Western Reserve, Cleveland, Ohio, United States; Recruiting
Jalal Abu-Shaweesh, MD, Phone: 216-844-3387, Email: Jalal.Abu-Shaweesh@UHhospitals.org
Jalal Abu-Shaweesh, MD, Principal Investigator

University of Pittsburgh, Pittsburgh, Pennsylvania 15122, United States; Recruiting
Toby Yanowitz, M.D., Phone: 412-641-6260, Email: tyanowitz@mail.magee.edu
Toby Yanowitz, M.D., Principal Investigator

Vanderbilt University, Nashville, Tennessee 37232, United States; Recruiting
Jeff Reese, MD, Phone: 615-322-8643, Email: jeff.reese@vanderbilt.edu
Jeff Reese, MD, Principal Investigator

University of Virginia, Charlottesville, Charlottesville, Virginia, United States; Recruiting
Josh Attridge, MD, Phone: 434-924-2490, Email: JA5U@hscmail.mcc.virginia.edu
Josh Attridge, MD, Principal Investigator

Starting date: July 2008
Ending date: July 2012
Last updated: August 17, 2009