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

Bronchopulmonary Dysplasia Clinical Trial

Official title:

The Use of Inhaled Nitric Oxide to Improve Respiratory Outcomes in Late Preterm Infants

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01748045
• Other study ID #: 10487
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: November 20, 2012
• Last updated: November 17, 2014
• Start date: March 2013
• Est. completion date: July 2014

Study information

• Verified date: November 2014
• Source: Tufts Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Weeks to 36 Weeks

Eligibility

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 > 1LPM, CPAP, or NIPPV for treatment of respiratory failure,

• Requiring a fraction of inspired oxygen (FIO2) of at least 0.25 to maintain 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 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia

Intervention

Drug:
• inhaled nitric oxide

• Placebo Comparator - nitrogen gas

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Tufts Medical Center	Ikaria

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary combined endpoint of alive without the need for intubation or mechanical ventilation within the first week of life		7 days	No
Secondary	Need for exogenous surfactant		7 days	No
Secondary	Total length of hospital stay	participants will be followed for the duration of hospital stay	At hospital discharge, anticipate up to 10 weeks	No
Secondary	Total duration of supplemental oxygen	participants will be followed for the duration of hospital stay for use of supplemental oxygen	anticipate average 4 weeks	No
Secondary	Diagnosis of BPD	Diagnosis of BPD by oxygen challenge test at 36 weeks PMA for infants born between 30 and 32 weeks GA. For those born 32 1/7 - 36 weeks, an oxygen challenge test will be performed at 1-2 months of age.	At 36 weeks postmenstrual age	No
Secondary	Evidence of chronic respiratory morbidity at 12 months 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)	12 months corrected gestational age	No
Secondary	Total Duration of Respiratory Support	participants will be followed for the duration of hospital stay for respiratory support	anticipate average 4 weeks	No