Inhaled Nitric Oxide and Neuroprotection in Premature Infants

NCT00515281 | Terminated Phase 2 Results DMC

• 1 other identifier: 15405A
• Study Type: interventional
• Target: 273
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether inhaled nitric oxide improves the neurological outcome for premature infants.

Conditions

Prematurity; Bronchopulmonary Dysplasia; Intraventricular Hemorrhage; Periventricular Leukomalacia

Keywords

prematurity; nitric oxide; bronchopulmonary dysplasia; intraventricular hemorrhage; periventricular leukomalacia; neurodevelopment

Outcome Measures

Primary Outcomes (2)

• Neurodevelopment

  Two years

• Bronchopulmonary Dysplasia (BPD) or Death

  Need for respiratory support at 36 weeks post-menstrual age, either as positive pressure or supplemental oxygen to maintain oxygen saturations \>90%, or death before discharge

  36 weeks of age corrected (BPD) or before discharge (death)

Secondary Outcomes (6)

• Death

  through discharge (up to 400 days)

• Bronchopulmonary Dysplasia

  36 weeks of age corrected

• Supplemental Oxygen Use

  40 weeks PMA

• BPD or Death in Infants Weighing < 750g

  36 weeks of age corrected (BPD) or before discharge (death)

• BPD or Death in Infants Weighing 750-999g

  36 weeks of age corrected (BPD) or before discharge (death)

Study Arms (2)

INO Control (Short iNO)

PLACEBO COMPARATOR

INO will be given to infants in the control group for the first 7 days of the study gas, then O2 or room air, as clinically appropriate, on the 8th day, until 33 weeks corrected age

Drug: inhaled nitric oxide

INO Treatment (Long iNO)

EXPERIMENTAL

The treatment group will receive iNO, combined with O2 or room air, until 33 weeks corrected age.

Drug: inhaled nitric oxide; Drug: oxygen

Interventions

inhaled nitric oxide DRUG

The amount of gas will be carefully controlled and adjusted to the level that best improves the function of subject's lungs. The subject will remain on inhaled nitric oxide until he/she reaches 33 weeks of gestation if assigned to the treatment arm, or until the 8th day of the study if he/she is assigned to the control arm.

Also known as: INO

INO Control (Short iNO); INO Treatment (Long iNO)

oxygen DRUG

The amount of gas will be carefully controlled and adjusted to the level that best improves the function of the subject's lungs. Subjects in the control arm of the study will receive oxygen beginning on the 8th day of the study until he/she reaches 33 weeks of gestation.

Also known as: O2

INO Treatment (Long iNO)

Eligibility Criteria

• Age: 2 Hours - 72 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Prematurity (birthweight ≤ 1500g, \< 31 weeks gestation)
• Requiring respiratory support
• Admitted to the NICU at the University of Chicago

You may not qualify if:

• Severe congenital anomalies
• Genetic syndromes
• Extremely sick preterm infants requiring very high ventilatory pressures (OI ≥ 20)
• Premature infants judged by the physician as nonviable

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (2)

• Schreiber MD, Gin-Mestan K, Marks JD, Huo D, Lee G, Srisuparp P. Inhaled nitric oxide in premature infants with the respiratory distress syndrome. N Engl J Med. 2003 Nov 27;349(22):2099-107. doi: 10.1056/NEJMoa031154.

  PMID: 14645637 BACKGROUND

• Mestan KK, Marks JD, Hecox K, Huo D, Schreiber MD. Neurodevelopmental outcomes of premature infants treated with inhaled nitric oxide. N Engl J Med. 2005 Jul 7;353(1):23-32. doi: 10.1056/NEJMoa043514.

  PMID: 16000353 BACKGROUND

MeSH Terms

Conditions

Premature Birth; Bronchopulmonary Dysplasia; Leukomalacia, Periventricular

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Encephalomalacia; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Results Point of Contact

• Title: Michael D. Schreiber, MD
• Organization: University of Chicago

mschreiber@bsd.uchicago.edu

773-702-6205

Study Officials

• Michael D. Schreiber, M.D.

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2007
• First Posted: August 13, 2007
• Study Start: May 1, 2008
• Primary Completion: June 7, 2023
• Study Completion: November 28, 2023
• Last Updated: October 17, 2024
• Results First Posted: October 17, 2024

Record last verified: 2024-07

Locations

US (1)