Brief Summary
This phase 3, multi-center, double blind, placebo-controlled, randomized clinical trial will attempt to demonstrate if preterm infants who require mechanical ventilation and/or positive pressure support at any point during days 5 to 14 after birth may benefit from treatment with iNO.
Brief Title
Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants
Detailed Description
Multi-center, double blind, placebo-controlled, randomized clinical trial. Infants who meet all enrollment criteria at any point during days 5 to 14 after birth will be randomized to inhaled NO starting at 20 ppm, or matching placebo, by means of a blinded INOvent® delivery device. 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 gestational age using a physiologic assessment of BPD.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Bronchopulmonary Dysplasia
Eligibility 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
* 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
Inclusion 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)
* 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)
Gender
All
Gender Based
false
Keywords
Bronchopulmonary Dysplasia, BPD
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
14 Days
Minimum Age
5 Days
NCT Id
NCT00931632
Org Class
Industry
Org Full Name
Mallinckrodt
Org Study Id
IK-3001-BPD-301
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome Measure
Survival Without BPD at 36 Weeks
Outcome Time Frame
Baseline, 36 weeks PMA
Secondary Outcomes
Outcome Description
Airway pressure support includes conventional mechanical ventilation, conventional, high frequency oscillatory ventilation, jet, continuous positive airway pressure, and other.
Outcome Time Frame
Through hospital discharge, an average of 105 days for placebo and 108 days for INO
Outcome Measure
Days of Airway Pressure Support - Intent-to-treat Population
Outcome Time Frame
Through hospital discharge, an average of 105 days for placebo and 108 days for INO
Outcome Measure
Length of Birth Hospitalization
Outcome Time Frame
Through hospital discharge, an average of 105 days for placebo and 108 days for INO
Outcome Measure
Number and Percentage of Participants With Use of Postnatal Corticosteroids for Bronchopulmonary Dysplasia
Outcome Time Frame
Through hospital discharge, an average of 105 days for placebo and 108 days for INO
Outcome Measure
Number and Percentage of Participants With Use of Postnatal Corticosteroids for Any Medical Reason
Outcome Time Frame
Through hospital discharge, an average of 105 days for placebo and 108 days for INO
Outcome Measure
Systemic Use of Postnatal Corticosteroids for Any Medical Reason
Outcome Time Frame
Through hospital discharge, an average of 105 days for placebo and 108 days for INO
Outcome Measure
Number of Days of Oxygen Use
Outcome Description
Severity of bronchopulmonary dysplasia defined by the fraction of inspired O2 concentration (FiO2) requirement.
Outcome Time Frame
36 weeks
Outcome Measure
Severity of Bronchopulmonary Dysplasia
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Child
Maximum Age Number (converted to Years and rounded down)
0
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Mamta Fuloria
Investigator Email
MFULORIA@montefiore.org
Investigator Phone
718-904-2821