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

NCT01748045 | Terminated Phase 2 Results DMC

• 1 other identifier: 10487
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchopulmonary Dysplasia

Keywords

Inhaled Nitric Oxide; Bronchopulmonary Dysplasia; Late Prematurity; Chronic Respiratory Morbidity

Outcome Measures

Primary Outcomes (1)

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

  7 days

Secondary Outcomes (6)

• Number of Participants Who Had the Need for Exogenous Surfactant

  7 days

• Total Length of Hospital Stay

  From hospital admission through discharge

• Total Duration of Supplemental Oxygen

  From Hospital Admission through discharge

• Diagnosis of Bronchopulmonary Dysplasia (BPD)

  At 36 weeks postmenstrual age or 1-2month of age

• Evidence of Chronic Respiratory Morbidity at 12 Months Corrected Gestational Age (CGA)

  12 months corrected gestational age

Study Arms (2)

inhaled Nitric Oxide

EXPERIMENTAL

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.

Drug: inhaled nitric oxide

Nitrogen Gas

PLACEBO COMPARATOR

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.

Drug: Placebo Comparator - nitrogen gas

Interventions

inhaled nitric oxide DRUG

Also known as: iNO, INOmax

inhaled Nitric Oxide

Placebo Comparator - nitrogen gas DRUG

Nitrogen Gas

Eligibility Criteria

• Age: 30 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \<48 hours of age,
• 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,
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tufts Medical Center: lead
• Mallinckrodt: collaborator

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Interventions

Inosine; Endothelium-Dependent Relaxing Factors

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Vasodilator Agents; Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Results Point of Contact

• Title: Dr. Christiane Dammann
• Organization: Tufts Medical Center

cdammann@tuftsmedicalcenter.org

617-636-8738

Study Officials

• Jennifer W Lee, MD, MS

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2012
• First Posted: December 12, 2012
• Study Start: March 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 19, 2017
• Results First Posted: July 19, 2017

Record last verified: 2017-06

Locations

US (1)