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Study of Inhaled Nitric Oxide (iNO) and Respiratory Outcomes in Late Preterm Infants

Primary Purpose

Bronchopulmonary Dysplasia

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
inhaled nitric oxide
Placebo Comparator - nitrogen gas
Sponsored by
Tufts Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bronchopulmonary Dysplasia focused on measuring Inhaled Nitric Oxide, Bronchopulmonary Dysplasia, Late Prematurity, Chronic Respiratory Morbidity

Eligibility Criteria

30 Weeks - 36 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • <48 hours of age,
  • 30 - 36 weeks gestational age at birth based on best estimate using obstetrical sonography (first or second trimester), solid dating criteria, or Ballard examination,
  • Birth weight of ≥ 1,000 g,
  • 5 minute Apgar score ≥5,
  • Requiring nasal cannula O2 > 1 liter per minute (LPM), continuous positive pressure (CPAP), or non invasive positive pressure ventilation (NIPPV) for treatment of respiratory failure,
  • Requiring a fraction of inspired oxygen (FIO2) of at least 0.25 to maintain arterial oxygen saturation (SaO2) 88-94%,
  • Parent or guardian has signed informed consent and agrees to all study- related procedures, including those required after hospital discharge.

Exclusion Criteria:

  • Major congenital anomaly
  • Intubation and surfactant in the delivery room or prior to enrollment in the Neonatal Intensive Care Unit (NICU). Excludes intubation for suctioning.
  • Known congenital infection (bacterial, viral),
  • Perinatal asphyxia (5 minute Apgar <5, umbilical artery pH < 7.0 or evidence of neonatal encephalopathy),
  • Mother and/or infant is enrolled in another clinical trial (excluding observational) or has received an investigational drug,
  • Has undergone or is anticipated to require a major surgical procedure within the first 48 h of life,
  • Any condition which could preclude receiving study drug or performing any study-related procedures,
  • Use of postnatal corticosteroids,
  • Parent or guardian is unable or unwilling to complete study procedures after hospital discharge.

Sites / Locations

  • Tufts Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

inhaled Nitric Oxide

Nitrogen Gas

Arm Description

iNO to start at 20 parts per million (ppm) for the first three days of life. The dose will then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.

Placebo gas will be adjusted the same as study gas: to start at 20ppm for the first three days of life. The dose will then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.

Outcomes

Primary Outcome Measures

Number of Participants Who Were Alive Without the Need for Intubation or Mechanical Ventilation Within the First Week of Life

Secondary Outcome Measures

Number of Participants Who Had the Need for Exogenous Surfactant
Total Length of Hospital Stay
participants who were followed for the duration of hospital stay
Total Duration of Supplemental Oxygen
Participants were followed for the duration of hospital stay for use of supplemental oxygen
Diagnosis of Bronchopulmonary Dysplasia (BPD)
Diagnosis of BPD by oxygen challenge test at 36 weeks post menstrual age (PMA) for infants born between 30 and 32 weeks gestational age (GA). For those born 32 1/7 - 36 weeks, an oxygen challenge test was performed at 1-2 months of age.
Evidence of Chronic Respiratory Morbidity at 12 Months Corrected Gestational Age (CGA)
defined by a validated system of parental diaries and pulmonary questionnaires, as well as review of medical records (medical visits, respiratory medication use, emergency room visits, and hospital re-admissions)
Total Duration of Respiratory Support
participants were followed for the duration of hospital stay for respiratory support

Full Information

First Posted
November 20, 2012
Last Updated
June 20, 2017
Sponsor
Tufts Medical Center
Collaborators
Mallinckrodt
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1. Study Identification

Unique Protocol Identification Number
NCT01748045
Brief Title
Study of Inhaled Nitric Oxide (iNO) and Respiratory Outcomes in Late Preterm Infants
Official Title
The Use of Inhaled Nitric Oxide to Improve Respiratory Outcomes in Late Preterm Infants
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Terminated
Why Stopped
Enrollenment has been suspended due to poor enrollment
Study Start Date
March 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts Medical Center
Collaborators
Mallinckrodt

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to determine if inhaled nitric oxide will improve short and long term respiratory outcomes in preterm infants. Infants born at a gestational age of 30-36 weeks and who require breathing support with high flow nasal cannula, nasal continuous positive airway pressure, or nasal intermittent positive pressure will be randomized to receive either inhaled nitric oxide or placebo. The dose will then be decreased per protocol until all respiratory support has been discontinued. Infants will be followed to evaluate safety and efficacy of non-invasive iNO delivery, up to 12 months corrected gestational age.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchopulmonary Dysplasia
Keywords
Inhaled Nitric Oxide, Bronchopulmonary Dysplasia, Late Prematurity, Chronic Respiratory Morbidity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
inhaled Nitric Oxide
Arm Type
Experimental
Arm Description
iNO to start at 20 parts per million (ppm) for the first three days of life. The dose will then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.
Arm Title
Nitrogen Gas
Arm Type
Placebo Comparator
Arm Description
Placebo gas will be adjusted the same as study gas: to start at 20ppm for the first three days of life. The dose will then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.
Intervention Type
Drug
Intervention Name(s)
inhaled nitric oxide
Other Intervention Name(s)
iNO, INOmax
Intervention Type
Drug
Intervention Name(s)
Placebo Comparator - nitrogen gas
Primary Outcome Measure Information:
Title
Number of Participants Who Were Alive Without the Need for Intubation or Mechanical Ventilation Within the First Week of Life
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Number of Participants Who Had the Need for Exogenous Surfactant
Time Frame
7 days
Title
Total Length of Hospital Stay
Description
participants who were followed for the duration of hospital stay
Time Frame
From hospital admission through discharge
Title
Total Duration of Supplemental Oxygen
Description
Participants were followed for the duration of hospital stay for use of supplemental oxygen
Time Frame
From Hospital Admission through discharge
Title
Diagnosis of Bronchopulmonary Dysplasia (BPD)
Description
Diagnosis of BPD by oxygen challenge test at 36 weeks post menstrual age (PMA) for infants born between 30 and 32 weeks gestational age (GA). For those born 32 1/7 - 36 weeks, an oxygen challenge test was performed at 1-2 months of age.
Time Frame
At 36 weeks postmenstrual age or 1-2month of age
Title
Evidence of Chronic Respiratory Morbidity at 12 Months Corrected Gestational Age (CGA)
Description
defined by a validated system of parental diaries and pulmonary questionnaires, as well as review of medical records (medical visits, respiratory medication use, emergency room visits, and hospital re-admissions)
Time Frame
12 months corrected gestational age
Title
Total Duration of Respiratory Support
Description
participants were followed for the duration of hospital stay for respiratory support
Time Frame
From hospital admission through discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Weeks
Maximum Age & Unit of Time
36 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: <48 hours of age, 30 - 36 weeks gestational age at birth based on best estimate using obstetrical sonography (first or second trimester), solid dating criteria, or Ballard examination, Birth weight of ≥ 1,000 g, 5 minute Apgar score ≥5, Requiring nasal cannula O2 > 1 liter per minute (LPM), continuous positive pressure (CPAP), or non invasive positive pressure ventilation (NIPPV) for treatment of respiratory failure, Requiring a fraction of inspired oxygen (FIO2) of at least 0.25 to maintain arterial oxygen saturation (SaO2) 88-94%, Parent or guardian has signed informed consent and agrees to all study- related procedures, including those required after hospital discharge. Exclusion Criteria: Major congenital anomaly Intubation and surfactant in the delivery room or prior to enrollment in the Neonatal Intensive Care Unit (NICU). Excludes intubation for suctioning. Known congenital infection (bacterial, viral), Perinatal asphyxia (5 minute Apgar <5, umbilical artery pH < 7.0 or evidence of neonatal encephalopathy), Mother and/or infant is enrolled in another clinical trial (excluding observational) or has received an investigational drug, Has undergone or is anticipated to require a major surgical procedure within the first 48 h of life, Any condition which could preclude receiving study drug or performing any study-related procedures, Use of postnatal corticosteroids, Parent or guardian is unable or unwilling to complete study procedures after hospital discharge.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer W Lee, MD, MS
Organizational Affiliation
Tufts Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States

12. IPD Sharing Statement

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Study of Inhaled Nitric Oxide (iNO) and Respiratory Outcomes in Late Preterm Infants

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