Effects of Inhaled Nitric Oxide in the Treatment of Acute Hypoxemic Respiratory Failure (AHRF) in Pediatrics

The Effects of Inhaled Nitric Oxide in the Treatment of Acute Hypoxemic Respiratory Failure (AHRF) In Pediatrics

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00041561

Enrollment

Registered

2002-07-11

Start date

2002-01-31

Completion date

2004-12-31

Last updated

2016-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anoxemia, Respiratory Insufficiency

Keywords

Acute hypoxemic respiratory failure

Brief summary

The purpose of this study is to determine the effect of nitric oxide for inhalation on the duration of mechanical ventilation in pediatric patients with AHRF.

Detailed description

Patients will receive 5-ppm study gas (nitric oxide for inhalation or placebo) until Day 28 or extubation, whichever comes first. The following will be performed / recorded at specified times during the study: arterial blood gases, ventilator settings, methemoglobin, PRISM III score, and patient positioning. Selected centers will also be performing plasma cytokine assays, broncho-alveolar lavage fluid assays and a 6 month follow-up assessment.

Interventions

DRUGNitrogen gas

Nitrogen gas will be given at 5ppm until Day 28 or extubation

DRUGinhaled nitric oxide

inhaled nitric oxide will be given at 5 ppm until day 28 or extubation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

No minimum to 16 Years

Healthy volunteers

Inclusion criteria

* Admitted to pediatric intensive care unit and have the diagnosis of acute respiratory failure * 44 weeks post conceptional age to 16 years of age * Oxygenation Index (OI) \>=12 cm H2O/mmHg (as determined by two separate measurement taken 30 minutes to 4 hours apart) * Recent chest x-ray (within 24 hours) showing at least unilateral infiltrations * Mechanically ventilated \<= 7 days

Exclusion criteria

* Immunocompromised * Received a bone marrow transplant * Active oncological condition * Persistent right to left intracardiac shunt * Cardiovascular surgery within the last 14 days * Status asthmaticus * Decision by primary care physician not to provide full support * Received treatment with nitric oxide for inhalation or other investigational medications within 24 hours prior to study initiation, participating in surfactant trials * Chronically ventilated * Pregnant

Design outcomes

Primary

Measure	Time frame
arterial blood gases	baseline through 24 hours and extubation

Secondary

Measure	Time frame
methemoglobin	baseline, hour 4 and 24 hours
broncho-alveolar lavage fluid	baseline, 48 hours and day 5
Prone position	baseline then daily

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026