Inhaled Nitric Oxide (INO) In Hypoxic Respiratory Failure

NCT00922532 | Withdrawn Phase 3

• 1 other identifier: IK-3001-HRF-301
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This Phase 3, Double-blind, Randomized, Placebo controlled, multicenter study is to confirm the efficacy of inhaled nitric oxide for the management of hypoxic respiratory failure associated with pulmonary hypertension in preterm infants. Study subjects will be administered either inhaled nitric oxide or placebo to determine if there is a change in oxygenation.

Conditions

Hypoxic Respiratory Failure With Pulmonary Hypertension

Keywords

Hypoxic Respiratory Failure (HRF), Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• Arterial Blood Gases

  Day 1 through Day 6

Secondary Outcomes (4)

• Methemoglobin levels

  Treatment Duration

• Vital Signs

  Study Duration

• Adverse Events

  Study Duration

• cGMP Levels

  Day 1 through 14

Study Arms (2)

Inhaled Nitric Oxide

EXPERIMENTAL

Inhaled Nitric Oxide

Drug: Inhaled Nitric Oxide

Nitrogen

PLACEBO COMPARATOR

Nitrogen Placebo

Drug: Placebo

Interventions

Inhaled Nitric Oxide DRUG

Inhaled Nitric Oxide will be administered continuously starting at 20ppm through an INOvent delivery system for up to 14 days.

Also known as: INOmax

Inhaled Nitric Oxide

Placebo DRUG

Nitrogen gas will be administered in the same manor as the experimental drug

Nitrogen

Eligibility Criteria

• Age: Up to 48 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infants who:
• Are in-born at \< 30 weeks gestational age
• Weigh 500-1250 grams
• Have hypoxic respiratory failure requiring mechanical ventilation with FiO2 \> 0.8 to maintain SaO2 ≥ 85% in the first 48 hours after birth after use of exogenous surfactant
• Have minimal parenchymal lung disease by chest X ray

You may not qualify if:

• Preterm infants who:
• Have ten minute Apgar score \< 5
• Have life-threatening anomalies (cardiac, thoracic, chromosomal) or congenital diaphragmatic hernia with lung hypoplasia, or any child who will not receive complete intensive care
• Have bilateral Grade IV Intraventricular Hemorrhage (IVH)
• Are dependent on right to left shunting to maintain the systemic circulation
• Have received prior iNO therapy
• Have had treatment with investigational medications

Sponsors & Collaborators

• Mallinckrodt: lead

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Endothelium-Dependent Relaxing Factors

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Vasodilator Agents; Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2009
• First Posted: June 17, 2009
• Study Start: November 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: September 9, 2016

Record last verified: 2016-09