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Home > "I" Clinical Trials Conditions > Inhaled NO for the Prevention of Chronic Lung Disease  Inhaled NO for the Prevention of Chronic Lung Disease
Inhaled NO for the Prevention of Chronic Lung Disease
For Condition: Bronchopulmonary Dysplasia,Lung Diseases
Status: Recruiting
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: To determine whether or not inhaled nitric oxide (NO) safely decreases the incidence of chronic lung disease in premature infants.
Details: BACKGROUND: Despite advances in medical, nursing, and respiratory care, chronic lung disease (CLD) inflicts up to 50 percent of the prematurely born infants. As a result, nearly 50,000 infants in the United States develop CLD. It is desirable to investigate therapies that decrease the incidence of CLD because it is associated with failure to thrive and developmental delay, and increased risk of pulmonary infection, reactive airway disease, pulmonary hypertension, and death. DESIGN NARRATIVE: Randomized, double-blind, placebo-controlled, and multi-centered. Three specific hypotheses are tested: that inhaled nitric oxide reduces the incidence of chronic lung disease, that inhaled nitric oxide reduces serum and lung (tracheal aspirate) markers of inflammation, and that inhaled nitric oxide does not increase the incidence of intraventricular hemorrhage in premature neonates. The primary endpoint is survival without chronic lung disease (defined as continued oxygen requirement) at 36 weeks post conceptional age. A total of 800 premature newborns will be enrolled from 14 centers within 48 hours of life and be randomized to receive either placebo or inhaled nitric oxide (iNO) at 5 ppm until extubation or 21 days. The randomization will be performed using random blocks of 2 or 4 babies within each center by 3 gestational age strata (500-749 grams, 750-999 grams, and 1000-1250 grams). The iNO will be delivered by an INOvent delivery system which will be shrouded so that treating physicians and nurses will be unaware of the treatment group. Management strategies for aspects of patient care including mechanical ventilation, surfactant administration, fluid administration and steroid use will be determined by each center. Serial cranial ultrasounds and methemoglobin levels will be monitored to determine adverse events. The first 200 patients will also have serial blood samples and tracheal aspirates obtained for measurements of inflammatory mediators including interleukin-6 (IL-6), interleukin-8 (IL-8), interleukin-10 (IL-10), endothelin-1, myeloperoxidase and neutrophil counts (tracheal aspirates) and endothelin-1 (blood). To determine the incidence of long-term cardiopulmonary or neurologic sequelae, patients will be seen at 12 and 24 months of age. At these assessments a health questionnaire will be administered and Bayley II scales of infant development will be completed.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Double-Blind, Placebo Control
Minimum Age/Maximum Age: /1 Year
Genders: Both
Protocol Entry Criteria: Eligibility Inclusion Criteria: -500-1250 grams birth weight and gestational age < 34 weeks -Less than 48 hours old -Respiratory Failure on mechanical ventilation -Absence of structural heart disease (except PDA, ASD<1cm, or VSD<2mm if known prior to randomization) -Absence of lethal congenital anomaly Exclusion Criteria: -Participating in another concurrent experimental study (observational studies will be allowed with prior approval by the Steering Committee and Data and Safety Monitoring Board) -Active Pulmonary Hemorrhage -Unevacuated Pneumothorax -High frequency jet ventilation -Expected short duration of ventilation (< 48 hours from birth)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JohnKinsella, , Children's Hospital
Univ. of Connecticut Health Center *Recruiting*
Farmington, Connecticut, 06030
United States
Recruiting Mariann Pappagallo 860-679-2000
Pennsylvania Hospital *Recruiting*
Philadelphia, Pennsylvania, 19107
United States
Recruiting Dr. Gerdes 215-829-6888
Medical University of So. Carolina *Recruiting*
Charleston, South Carolina, 29425
United States
Recruiting W. Southgate 843-792-2300
Utah Valley Regional Med. Ctr. *Recruiting*
Provo, Utah, 84604
United States
Recruiting Dale Gerstmann 801-373-7850
USC/Good Samaritan Hospital *Recruiting*
Los Angeles, California, 90033
United States
Recruiting Smeeta Sardesai 323-442-8500
Univ. of North Carolina Chapel Hill *Recruiting*
Chapel Hill, North Carolina, 27599
United States
Recruiting Carl Bose 919-962-2211
Duke Univ. Medical Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Richard Auten 919-684-8111
Loma Linda U. Medical Center *Recruiting*
Loma Linda, California, 92350
United States
Recruiting Heather Carriedo 909-558-4000
Magee-Women's Hospital *Recruiting*
Pittsburgh, Pennsylvania, 15213
United States
Recruiting Claudia Hart 412-641-1000
Children's Hospital *Recruiting*
Denver, Colorado, 80218-1088
United States
Recruiting John Kinsella 303-861-6194
Vanderbilt Univ. Med. Center *Recruiting*
Nashville, Tennessee, 37232
United States
Recruiting William Walsh 615-322-5000
St. Joseph's Hospital *Recruiting*
Phoenix, Arizona, 85013
United States
Recruiting David Hall 602-406-3000
Children's Hospital of Okla *Recruiting*
Oklahoma City, Oklahoma, 73104
United States
Recruiting Kris Sekar 405-271-5437
Univ. of Iowa Hosp. & Clinics *Recruiting*
Iowa City, Iowa, 52242
United States
Recruiting Thomas George 800-777-8442
Additional Information:
Study ID Numbers: 135;
Study Start Date: September 2000
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006401
Other Lung Diseases Studies:
1. Benchmarking Initiative to Reduce Bronchopulmonary Dysplasia
2. Premature Birth and its Sequelae in Women
3. Phase II Pilot Study of Early Cortisol Replacement to Prevent Bronchopulmonary Dysplasia
4. Inhaled NO for the Prevention of Chronic Lung Disease
5. High Frequency Ventilation in Premature Infants (HIFI)
Related Studies:
Other Lung Diseases Clinical Trials
Other Colorado Clinical Trials
Other Denver Clinical Trials
Inhaled NO for the Prevention of Chronic Lung Disease
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