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Examining the Use of Non-Invasive Inhaled Nitric Oxide to Reduce Chronic Lung Disease in Premature Newborns

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00955487
First received: August 6, 2009
Last updated: May 22, 2017
Last verified: May 2017
August 6, 2009
May 22, 2017
January 2007
July 2014   (Final data collection date for primary outcome measure)
  • Combined Endpoint of Bronchopulmonary Dysplasia (BPD) or Mortality [ Time Frame: Week 36 or earlier, if participants are discharged from the hospital ]
    Number of participants that developed bronchopulmonary dysplasia and/or that died
  • Combined Endpoint of Bronchopulmonary Dysplasia (BPD) or Mortality Stratified by Birth Weight [ Time Frame: Randomization to discharge ]
    Number of participants that developed bronchopulmonary dysplasia and/or that died, stratified by birth weight (grams)
combined endpoint of bronchopulmonary dysplasia/mortality [ Time Frame: Week 36 or earlier if discharged ]
Complete list of historical versions of study NCT00955487 on ClinicalTrials.gov Archive Site
  • Severity of Bronchopulmonary Dysplasia (BPD) [ Time Frame: 36 weeks corrected gestational age ]
    Assessment of the severity of BPD as defined by the oxygen reduction test
  • Need for Mechanical Ventilation [ Time Frame: Anytime after randomization up to 36 weeks corrected gestational age ]
    Number of participants who required endotracheal intubation and mechanical ventilation
  • Total Ventilation Days [ Time Frame: After randomization up until hospital discharge ]
    Of those participants who required mechanical ventilation, the total number of days receiving ventilation
  • Necrotizing Enterocolitis (NEC) [ Time Frame: After randomization through hospital discharge ]
    Number of participants diagnosed with necrotizing enterocolitis
  • Symptomatic PDA Requiring Medical Treatment [ Time Frame: From randomization until discharge ]
    Number of participants with a symptomatic PDA that required medical treatment
  • Symptomatic PDA Requiring Surgical Ligation [ Time Frame: Randomization through discharge ]
    Number of participants with symptomatic PDA that required surgical ligation
  • Threshold Retinopathy of Prematurity (ROP) [ Time Frame: Randomization to discharge ]
    Threshold ROP defined as requiring interventional therapy
  • Severe Intracranial Hemorrhage [ Time Frame: Randomization to discharge ]
    Number of participants that developed severe intracranial hemorrhage (grade 3-4)
  • Sepsis [ Time Frame: Randomization to discharge ]
    Number of participants that developed sepsis
Pulmonary hypertension [ Time Frame: Week 36 or earlier if discharged ]
Days in Hospital [ Time Frame: From birth to hospital discharge ]
Length of stay of participants
Not Provided
 
Examining the Use of Non-Invasive Inhaled Nitric Oxide to Reduce Chronic Lung Disease in Premature Newborns
Examining the Use of Non-Invasive Inhaled Nitric Oxide to Reduce Chronic Lung Disease in Premature Newborns
Bronchopulmonary dysplasia (BPD) is a serious lung condition that affects premature newborns. The condition involves abnormal development of lung tissue and is characterized by inflammation and scarring in the lungs. Treatment with inhaled nitric oxide (iNO) may reduce the incidence of BPD and another commonly associated condition called pulmonary hypertension, which is high blood pressure in the vessels carrying blood to the lungs.. This study will determine if early treatment with low-dose iNO reduces the incidence of BPD, pulmonary hypertension, and death in premature newborns.

BPD is a serious lung condition that primarily affects premature newborns and newborns with low birth weights. iNO has been proven to be a safe and effective treatment for pulmonary hypertension and hypoxemic respiratory failure—both of which are abnormal lung conditions—in full-term newborns. However, in babies born prematurely, the effects of iNO on lung function are not well defined. Also, previous studies have mainly examined whether iNO reduces the incidence of BPD in newborns who are on mechanical ventilation. However, intubation and mechanical ventilation of premature newborns is now increasingly being avoided, and non-invasive support, including the use of nasal continuous positive airway pressure (NCPAP), is being used. Early treatment with low-dose iNO may reduce the incidence of BPD in premature newborns who do not require mechanical ventilation and intubation after delivery. The purpose of this study is to determine if low-dose, non-invasive iNO reduces the risk of BPD, pulmonary hypertension, and death in premature newborns who do not require mechanical ventilation.

This study will enroll premature newborns who require extra oxygen but do not require intubation or mechanical ventilation for respiratory failure in the first 72 hours of life. Participants will be randomly assigned to receive low-dose, non-invasive iNO or nitrogen (placebo) during their hospital stay. While hospitalized, participants' heart rate, blood oxygen level breathing rate, blood pressure, and medications will be monitored, and blood collection will occur at various times. Monitoring will continue until participants are 30 weeks corrected gestational age or for at least 14 days if participants are born at 29 weeks or more. All participants will undergo an ultrasound of the head when they are 7 days, 28 days, and 36 weeks of age. They will undergo an echocardiogram, which is an ultrasound of the heart, at 7 and 21 days of age and 4 weeks before the original expected due date. A chest x-ray will be performed before hospital discharge, and a breathing status test will be performed either 4 weeks before participants' original expected due date or before hospital discharge. Follow-up study visits will occur at Years 1 and 2, and will include a physical examination and developmental and behavioral testing. Another echocardiogram will also be performed at the Year 1 visit.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Prevention
Bronchopulmonary Dysplasia
  • Drug: Inhaled Nitric Oxide (iNO)
    iNO will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx).
  • Drug: Nitrogen (placebo)
    Nitrogen will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx).
  • Experimental: Inhaled Nitric Oxide (iNO)
    Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.
    Intervention: Drug: Inhaled Nitric Oxide (iNO)
  • Placebo Comparator: Nitrogen (placebo)
    Participants will receive nitrogen (placebo) while in the hospital.
    Intervention: Drug: Nitrogen (placebo)
Kinsella JP, Cutter GR, Steinhorn RH, Nelin LD, Walsh WF, Finer NN, Abman SH. Noninvasive inhaled nitric oxide does not prevent bronchopulmonary dysplasia in premature newborns. J Pediatr. 2014 Dec;165(6):1104-1108.e1. doi: 10.1016/j.jpeds.2014.06.018. Epub 2014 Jul 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
124
December 2014
July 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Birth weight of 500-1250 grams and gestational age of less than 34 weeks
  • Age at enrollment is less than 72 hours
  • Supplemental oxygen or 21% requirement by nasal cannula or NCPAP only

Exclusion Criteria:

  • Presence of structural heart disease (other than patent ductus arteriosus, atrial septal defect less than 1 cm, or muscular ventricular septal defect less than 2 mm)
  • Presence of lethal congenital anomaly
  • Participating in another concurrent experimental study
  • Requires mechanical ventilation in the first 72 hours of life (patients are not excluded if they are intubated briefly but they must be extubated at the time of consent and study entry prior to 72 hours of life)
Sexes Eligible for Study: All
up to 72 Hours   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00955487
06-0124
5P50HL084923 ( US NIH Grant/Contract Award Number )
5 P50 HL084923-030001
Yes
Not Provided
Not Provided
Not Provided
University of Colorado, Denver
University of Colorado, Denver
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: John Kinsella, MD Chidlren's Hospital and University of Colorado Hospital
University of Colorado, Denver
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP