Table 4. Detailed analysis of randomized-controlled trials evaluating iNO: Inhaled Nitric Oxide (iNO) in neonates.
| N | Estimated dates of Start / End (years) * | Title / Primary outcome / Long-term follow-up | Trial status** Principal Investigator (PI) (Publications) |
|---|---|---|---|
| 1 | 1995 / 1998 NCT00005776 |
Inhaled Nitric Oxide Study for Respiratory Failure in Newborns (NINOS) PO: Death or initiation of ECMO before hospital discharge or 120 days of life LT: outcome assessed at 18 to 24 mos of age. |
Terminated PI: RA. Ehrenkranz [28] |
| 2 | 2000/2006 NCT00000548 |
Inhaled NO in Prevention of Chronic Lung Disease PO: Survival without chronic lung disease (CLD) [Time Frame: 36 weeks] LT: Neurodevelopmental outcome through two years of age |
Completed PI: Ballard R [29] |
| 3 | 2001 / 2006 NCT00016523 |
Inhaled Nitric Oxide for Preterm Infants With Severe Respiratory Failure (Preemie iNO) PO: Death or Bronchopulmonary Dysplasia at 36 weeks post-conceptional age LT: Neurodevelopmental outcome at 18–22 months corrected age |
Terminated PI: KP Van Meurs [30] |
| 4 | 2002 / 2005 NCT00041548 |
Inhaled Nitric Oxide in Neonates With Elevated A-a DO2 (alveolar-arterial oxygen) Gradients Not Requiring Mechanical Ventilation (gestational age >34 completed weeks) PO: PaO2 level at baseline, then every hour for 6 hours LT: no |
Terminated PI: Waldemar Carlo [31] |
| 5 | 2005 /2016 NCT01220687 |
Safety and Efficacy Study of Nitric Oxide for Inhalation on Chronic Lung Disease in Premature Babies PO: Survival Without Bronchopulmonary Dysplasia (BPD) in Preterm Infants With Respiratory Distress at 36 weeks gestational age LT: no |
Active, not recruiting PI: JCMercier [32] |
| 6 | 2007 / 2016 NCT00955487 |
Examining the use of non-invasive inhaled nitic oxide to reduce chronic lung disease on premature newborns. PO: Combined endpoint of bronchopulmonary dysplasia and mortality [Time Frame: Week 36 or earlier, if participants are discharged from the hospital LT: Long term follow up at 1 and 2 years |
Ongoing, but not recruiting PI: J Kinsella [33] |
| 7 | 2008 / 2016 NCT00515281 |
Inhaled Nitric Oxide and Neuroprotection in Premature Infants PO: Bronchopulmonary dysplasia at 36 weeks of age corrected LT: Neurodevelopment at two years |
Active—not recruiting PI: MD. Schreiber |
| 8 | 2009/2011 NCT00922532 |
Inhaled Nitric Oxide (INO) In Hypoxic Respiratory Failure PO: Arterial Blood Gases [Time Frame: Day 1 through Day 6] LT: no |
Withdrawn prior to enrollment. |
| 9 | 2009 / 2014 NCT00931632 |
Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants PO: Survival Without BPD at 36 Weeks LT: no |
Completed Study Director: J Baldassarre |
| 10 | 2011 / 2016 NCT01220687 |
Inhaled Nitric Oxide (iNO) as an Adjunct to Neonatal Resuscitation PO: To investigate whether iNO decreases the supplemental oxygen exposure in the preterm infants who require continuous positive airway pressure (CPAP) or positive pressure ventilation (PPV) during resuscitation as per Neonatal Resuscitation Program (NRP) protocol. LT: no |
Recruiting PI: Kris Sekar, |
| 11 | 2013 / 2014 NCT01748045 |
Study of Inhaled Nitric Oxide and Respiratory Outcomes in Late Preterm Infants PO: Primary combined endpoint of alive without the need for intubation or mechanical ventilation within the first week of life LT: no |
Terminated PI: Jennifer W Lee |
| 12 | 2016 / 2017 NCT01891500 |
Early iNO for Oxidative Stress, Vascular Tone and Inflammation in Babies With Hypoxic Respiratory Failure (gestational Gestational age ≥ 35 weeks gestation) PO: Biomarkers of oxidative injury. LT: no |
Not yet open for recruitment PI: C Bazacliu |
* estimated year
** Definitions as provided in Clinicaltrial.gov: Completed: "last subject, last visit" has occurred, Terminated: the clinical study has stopped recruiting or enrolling participants early and will not start again, Participants are no longer being examined or treated.
PO: Primary Objective, LO: Long-term, PI: Principal Investigator