Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants

Condition(s) targeted: Bronchopulmonary Dysplasia

Intervention: Inhaled Nitric Oxide (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: INO Therapeutics

Official(s) and/or principal investigator(s):
James Baldassarre, MD, Study Director, Affiliation: INO Therapeutics

Overall contact:
Karen Kelly, Phone: 908-238-6387, Email: karen.kelly@ikaria.com

This phase 3, multi-center, double blind, placebo-controlled, randomized clinical trial will attempt to demonstrate if preterm infants who require mechanical ventilation or positive pressure support at any point during days 5 to 14 after birth may benefit from treatment with iNO.

Official title: Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants Requiring Mechanical Ventilation or Positive Pressure Support on Days 5-14 After Birth

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Arterial Blood Gases

Secondary outcome:

Vital Signs

Methemoglobin levels

cGMP levels

Adverse Events

Serious Adverse Events

Detailed description: This trial will be a multi-center, double blind, placebo-controlled, randomized clinical trial. All infants < 30 weeks GA at birth will be screened for enrollment. Infants who require mechanical ventilation or positive pressure support at any point during days 5 to 14 after birth will be randomized to iNO starting at 20 ppm, or matched placebo, by means of a blinded INOvent® delivery device. Randomization will be stratified by center and gestational age (< 27 weeks GA and 27 to 30 weeks GA), and treatment will be assigned using an interactive voice or web-based response system. All infants will receive 24 days of therapy, following a dose reduction schedule. Infants who are extubated before 24 days will continue therapy via nasal continuous positive airway pressure (CPAP) or nasal cannula to complete 24 days of therapy. The primary outcome measure will be survival without BPD at 36 weeks postmenstrual age (PMA) using a physiologic assessment of BPD.

Minimum age: N/A. Maximum age: 14 Days. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Preterm infants who are:

1. 500 to 1250 grams at birth

2. < 30 weeks gestational age

3. 5 to 14 days of age (inclusive) at the time of entry

4. Requiring mechanical ventilation or for those infants ≤ 800 grams, positive pressure support (including CPAP) for respiratory insufficiency on days 5 to 14 days of age (inclusive)

Exclusion Criteria:

1. Preterm infants with life-threatening anomalies (cranial, cardiac, thoracic, chromosomal) or congenital diaphragmatic hernia with lung hypoplasia, or any subject who will not receive complete intensive care

2. Preterm infants with bilateral Grade 4 intraventricular hemorrhage (IVH)

3. Subjects who are dependent on right to left shunting to maintain the systemic circulation

4. Preterm infants who received prior iNO therapy

5. Use of another investigational agent

Karen Kelly, Phone: 908-238-6387, Email: karen.kelly@ikaria.com

Centre Hospitalier Universitaire de Quebec, Quebec G1V 4G2, Canada; Recruiting
Mylene Leblanc, Phone: 418-654-2282, Email: mylene.leblanc@crchul.ulaval.ca
George Caouette, MD, Principal Investigator

University of Calgary, Calgary, Alberta T2N 4N1, Canada; Recruiting
Jennifer M Schneider, Phone: 403-830-6976, Email: jlowden@ucalgary.ca
Yung Pham, Phone: 403-944-1579, Email: yung.pham@albertahealthservices.ca
Shabih U Hasan, MD, Principal Investigator

Phoenix Children's Hospital, Phoenix, Arizona 85006, United States; Recruiting
Irene Pacheco, RN, BSN, Phone: 480-318-8367
Gregory C Martin, MD, Principal Investigator

St. Joseph's Hospital and Medical Center, Phoenix, Arizona 85013, United States; Recruiting
Emily Khoury, Phone: 602-406-3614, Email: emily.khoury@chw.edu
Jeanne Zenge, MD, Principal Investigator

Loma Linda University School of Medicine, Loma Linda, California 92354, United States; Recruiting
Ricardo Parker, Phone: 909-558-7428, Email: rparker@llu.edu
Michael Terry, BS, RRT, Phone: 909-558-4000, Ext: 46209, Email: mterry@llu.edu
Yomma Ibrahim, MD, Principal Investigator

Children's Hospital of Orange County, Orange, California 92868, United States; Recruiting
Heather Terry, CRC, Phone: 714-532-8810, Email: HTerry@choc.org
John P Cleary, MD, Principal Investigator

Stanford University School of Medicine, Palo Alto, California 94304, United States; Recruiting
M Bethany Ball, Phone: 650-725-8342, Email: mbball@stanford.edu
Krista P Van Meurs, MD, Principal Investigator

Rady Children's Hospital of San Diego, San Diego, California 92123, United States; Recruiting
Aimee Canepa, Phone: 858-246-0010, Email: acanepa@ucsd.edu
Ellen Knodel, RRT, Phone: 858-966-1700, Ext: 3436, Email: eknodel@rchsd.org
Amy Kimball, MD, Principal Investigator

Sharp Mary Birch Hospital for Women and Newborns, San Diego, California 92123, United States; Recruiting
Kathy Arnell, Phone: 858-939-4966, Email: kathy.arnell@sharp.com
Maynard R Rasmussen, MD, Principal Investigator

Connecticut Children's Medical Center, Hartford, Connecticut 06106, United States; Withdrawn

Winnie Palmer Hospital for Women and Babies, Orlando, Florida 32806, United States; Recruiting
Paige Wilson, Phone: 407-841-5218, Email: Paige.Wilson@orlandohealth.com
Julio Ramos, Phone: 321-841-5198, Email: Julio.Ramos@orlandohealth.com
Jose Perez, MD, Principal Investigator

University of So Florida College of Medicine, Tampa, Florida 33606, United States; Withdrawn

Medical College of Georgia, Augusta, Georgia 30912, United States; Recruiting
Delores C Gillis, Phone: 706-721-3518, Email: dgillis@mail.mcg.edu
Chantrapa Bunyapen, MD, Principal Investigator

Rush University Medical Center, Chicago, Illinois 60612, United States; Withdrawn

Advocate Lutheran General Children's Hospital, Park Ridge, Illinois 60068, United States; Recruiting
Ramona Donovan, Phone: 847-723-7157, Email: ramona.donovan@advocatehealth.com
Nancy Marshall, Phone: 847-723-5090, Email: nancy.marshall@advocatehealth.com
Bhagya Lakshmi Puppala, MD, Principal Investigator

Riley Hospital for Children, Indianapolis, Indiana 46202, United States; Recruiting
Leslie Wilson, Phone: 317-274-8255, Email: ldw@uipui.edu
Gregory M Sokol, MD, Principal Investigator

University of Louisville School of Medicine, Louisville, Kentucky 40202, United States; Recruiting
Brandi Hubbuch, Phone: 502-852-8470, Email: bmhubb01@louisville.edu
Scott McClure, Phone: 502-629-5768, Email: scott.mcclure@nortonhealthcare.org
Tonya Robinson, MD, Principal Investigator

Floating Hospital for Children at Turfs Medical Center, Boston, Massachusetts 02111, United States; Withdrawn

Hennepin County Medical Center, Minneapolis, Minnesota 55415, United States; Recruiting
Sarah Pittelkow, Phone: 612-873-2955, Email: Sarah.pittelkow@hcmed.org
Raul Cifuentes, MD, Principal Investigator

Saint Barnabas Medical Center, Livingston, New Jersey 07039, United States; Recruiting
Deborah A Cialfi, Phone: 973-322-2631, Email: dcialfi@sbhcs.com
Robert Tero, Phone: 973-322-5437, Email: rtero@sbhcs.com
Shyan Sun, MD, Principal Investigator

Jersey Shore University Medical Center, Neptune, New Jersey 07754, United States; Recruiting
Gail London, Phone: 732-776-4295, Email: Glondon@meridanhealth.com
Eduardo Bautista, MD, Principal Investigator

Robert Wood Johnson University Hospital, New Brunswick, New Jersey 08901, United States; Recruiting
Lisa Cerracchio, Phone: 732-235-5976, Email: cerrali@umdnj.edu
Dana Saporito, Phone: 732-828-3000, Ext: 2444, Email: dana.saporito@rwjun.edu
Surasak Puvabanditsin, MD, Principal Investigator

Montefiore Medical Center, Bronx, New York 10461, United States; Recruiting
Melissa Vega, PA, Phone: 718-904-4105, Email: mevega@montefiore.org
Yvonne Gayle, Pharm D., Phone: 718-904-2825, Email: ygayle@montefiore.org
Mamta Fuloria, MD, Principal Investigator

Winthrop University Hospital, Mineola, New York 11501, United States; Recruiting
Ann Mock, Phone: 516-663-9619, Email: AMpck@Winthrop.org
Caroline Butkiewicz, RRT, Phone: 516-663-4466, Email: CButkiewicz@Winthrop.org
Nazeeh Hanna, MD, Principal Investigator

Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, New York 10595, United States; Recruiting
Natalie Dweck, Phone: 914-493-8998, Email: natalie_dweck@nymc.edu
Sergio Golombek, MD, Principal Investigator

WakeMed Faculty Physicians, Neonatology, Raleigh, North Carolina 27610, United States; Recruiting
Stephen D Kicklighter, MD
Teresa Batten, Phone: (919) 350-8931, Email: tbatten@wakemed.org
Stephen D Kicklighter, MD, Principal Investigator

Mercy Children's Hospital, Toledo, Ohio 43608, United States; Recruiting
Joan Zolla-Boldt, Phone: 419-251-2704, Email: Joan_zolla_boldt@mhsnr.org
Minda Te, MD, Principal Investigator

Saint Francis Children's Hospital, Tulsa, Oklahoma 74136, United States; Recruiting
Jennifer Lorton, Phone: 918-494-2277, Email: jmlorton@saintfrancis.com
Michael Gomez, MD, Principal Investigator

Greenville Memorial Hospital, Greenville, South Carolina 29605, United States; Recruiting
Ara Messamer, Phone: 864-455-7165, Email: arajaym@msn.com
Marshall Walker, MD, Principal Investigator

Sanford Children's Hospital, Sioux Falls, South Dakota 57117, United States; Recruiting
Rachel Klinghagen, RN, Phone: 605-312-1081, Email: klinghar@sanfordhealth.org
Mohammed Akram Khan, MD, Principal Investigator

Primary Children's Medical Center, Salt Lake City, Utah 84113, United States; Recruiting
Karen Osborne, Phone: 801-213-3298, Email: karen.osborne@hsc.utah.edu
Karen Hillier, Phone: (801) 581-2333, Email: karen.hillier@hsc.utah.edu
Robert J DiGeronimo, MD, Principal Investigator

Virginia Commonwealth University, Richmond, Virginia 23298, United States; Withdrawn

Wheaton Franciscan Healthcare, Milwaukee, Wisconsin 53210, United States; Recruiting
Collen Alex, Phone: 414-447-2068, Email: colleen.alex@wfhc.org
Jeffrey S Garland, MD, Principal Investigator

Children's Corporate Center, Division of Neonatology, Wauwatosa, Wisconsin 53226, United States; Recruiting
Laura Lane, Phone: 414-337-7312, Email: llane@mcw.edu
Mike Paquette, Phone: (414) 266-2780, Email: mpaquette@chw.org
Girija G Konduri, MD, Principal Investigator

Starting date: November 2009
Last updated: October 19, 2011