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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01748045
Other study ID # 10487
Secondary ID
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


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
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