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Feeding During Ibuprofen or Indomethacin Treatment of Preterm Infants

NCT ID: NCT00728117

Last Updated: 2012-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

177 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2012-09-30

Brief Summary

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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

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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.

Conditions

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Patent Ductus Arteriosus

Keywords

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indomethacin ibuprofen preterm infant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ibuprofen-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 and 24 hours after the last dose of ibuprofen.

Group Type EXPERIMENTAL

feeding

Intervention Type OTHER

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.

ibuprofen-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 and 24 hours after the last dose of ibuprofen.

Group Type EXPERIMENTAL

fasting

Intervention Type OTHER

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.

indomethacin-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 indomethacin and 24 hours after the last dose of indomethacin.

Group Type EXPERIMENTAL

feeding

Intervention Type OTHER

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.

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 indomethacin and 24 hours after the last dose of indomethacin.

Group Type EXPERIMENTAL

fasting

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

23 Weeks

Maximum Eligible Age

33 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ronald Clyman, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California san Francisco

San Francisco, California, United States

Site Status

Santa Clara Valley Medical Center

San Jose, California, United States

Site Status

Children's Memorial Hospital-Northwestern University

Chicago, Illinois, United States

Site Status

North Shore University Health System, Northwestern University

Evanston, Illinois, United States

Site Status

Boston University-Boston Medical Center

Boston, Massachusetts, United States

Site Status

Children's Hospital-Minneapolis

Minneapolis, Minnesota, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Children's Hospital-Saint Paul

Saint Paul, Minnesota, United States

Site Status

Atlantic Health Organization

Morristown, New Jersey, United States

Site Status

Columbia University

New York, New York, United States

Site Status

Case Western Reserve

Cleveland, Ohio, United States

Site Status

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Vanderbilt University

Nashville, Tennessee, United States

Site Status

University of Virginia, Charlottesville

Charlottesville, Virginia, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 24321538 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23472765 (View on PubMed)

Other Identifiers

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RC3

Identifier Type: -

Identifier Source: org_study_id