Trial of Late Surfactant to Prevent BPD: A Pilot Study in Ventilated Preterm Neonates Receiving Inhaled Nitric Oxide

NCT00569530 | Completed Phase 3 Results

• 2 other identifiers: H10842-31630-01IND79367
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 9

Brief Summary

The purpose of this study is to determine if the combination of late doses of Infasurf with inhaled nitric oxide will interact to improve the surfactant function and thus the respiratory status and outcome of treated infants.

Conditions

Respiratory Distress Syndrome of Prematurity (Surfactant Dysfunction); Bronchopulmonary Dysplasia

Keywords

nitric oxide; surfactant; bronchopulmonary dysplasia; prematurity; neonates; iNO; Infasurf; lung function; ventilated infants

Outcome Measures

Primary Outcomes (1)

• SP-B Content

  SP-B Content is the surfactant protein B found in terms of percentage of phospholipid measured one day after surfactant or sham dose.

  One day after dose

Secondary Outcomes (1)

• Alive Without BPD at 36 Weeks Post Menstrual Age

  36 Weeks Post Menstrual Age

Study Arms (2)

Treatment Surfactant (Infasurf) ONY, NY

ACTIVE COMPARATOR

Patients receive inhaled nitric oxide and scheduled doses of Infasurf on study days 0, 3, 7, 10, and 14, if infant remains ventilated.

Drug: Infasurf (ONY Inc.)

Sham (no treatment)

PLACEBO COMPARATOR

Infants receiving inhaled nitric oxide will receive Sham (no treatment) on study days 0, 3, 7, 10, and 14, if infant remains ventilated.

Drug: Sham

Interventions

Infasurf (ONY Inc.) DRUG

Infasurf 3ml/kg will be given to infants on study days 0, 3, 7, 10, and 14, if remains intubated.

Also known as: Infasurf

Treatment Surfactant (Infasurf) ONY, NY

Sham DRUG

Sham instillation (no treatment) will be given to study infants on days 0, 3, 7, 10, and 14, if remains intubated.

Also known as: Air

Sham (no treatment)

Eligibility Criteria

• Age: 7 Days - 14 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Less than or equal to 1000 gm. birth weight
• Less than or equal to 30 weeks gestational age
• Day 7-14 of life
• Intubated and mechanically ventilated at any time days 7-14 of life

You may not qualify if:

• Serious congenital malformations
• Life expectancy less than 7 days from enrollment
• Previous treatment with iNO
• Active pulmonary hemorrhage at time of enrollment
• Active air leak syndrome at time of enrollment
• Bilateral grade IV intracranial hemorrhage prior to enrollment
• Less than 48 hours from last clinical dose of early surfactant.

Sponsors & Collaborators

• Roberta Ballard: lead
• Mallinckrodt: collaborator
• ONY: collaborator

Study Sites (9)

Alta Bates Summit Medical Center

Berkeley, California, 94705, United States

Location

Children's Hospital Oakland

Oakland, California, 94609, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Children's Memorial Hospital

Chicago, Illinois, 60614, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Women and Children's Hospital of Buffalo

Buffalo, New York, 14222, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Publications (4)

• Ballard RA, Truog WE, Cnaan A, Martin RJ, Ballard PL, Merrill JD, Walsh MC, Durand DJ, Mayock DE, Eichenwald EC, Null DR, Hudak ML, Puri AR, Golombek SG, Courtney SE, Stewart DL, Welty SE, Phibbs RH, Hibbs AM, Luan X, Wadlinger SR, Asselin JM, Coburn CE; NO CLD Study Group. Inhaled nitric oxide in preterm infants undergoing mechanical ventilation. N Engl J Med. 2006 Jul 27;355(4):343-53. doi: 10.1056/NEJMoa061088.

  PMID: 16870913 BACKGROUND

• Ballard PL, Merrill JD, Truog WE, Godinez RI, Godinez MH, McDevitt TM, Ning Y, Golombek SG, Parton LA, Luan X, Cnaan A, Ballard RA. Surfactant function and composition in premature infants treated with inhaled nitric oxide. Pediatrics. 2007 Aug;120(2):346-53. doi: 10.1542/peds.2007-0095.

  PMID: 17671061 BACKGROUND

• Truog WE, Ballard PL, Norberg M, Golombek S, Savani RC, Merrill JD, Parton LA, Cnaan A, Luan X, Ballard RA; Nitric Oxide (to Prevent) Chronic Lung Disease Study Investigators. Inflammatory markers and mediators in tracheal fluid of premature infants treated with inhaled nitric oxide. Pediatrics. 2007 Apr;119(4):670-8. doi: 10.1542/peds.2006-2683.

  PMID: 17403837 BACKGROUND

• Keller RL, Merrill JD, Black DM, Steinhorn RH, Eichenwald EC, Durand DJ, Ryan RM, Truog WE, Courtney SE, Ballard PL, Ballard RA. Late administration of surfactant replacement therapy increases surfactant protein-B content: a randomized pilot study. Pediatr Res. 2012 Dec;72(6):613-9. doi: 10.1038/pr.2012.136. Epub 2012 Oct 4.

  PMID: 23037875 BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome; Surfactant Dysfunction; Bronchopulmonary Dysplasia; Premature Birth

Interventions

calfactant; salicylhydroxamic acid; Air

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Ventilator-Induced Lung Injury; Lung Injury; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health

Limitations and Caveats

More frequent dosing, with the resultant improvements in lung function, may allow for more rapid weaning from mechanical ventilation, leading to improved pulmonary outcomes, both short-term and long-term. Modifications to protocol being investigated.

Results Point of Contact

• Title: Roberta R. Keller, MD
• Organization: University of California, San Francisco

roberta.keller@ucsf.edu

415-514-3192

Study Officials

• Roberta A Ballard, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 5, 2007
• First Posted: December 7, 2007
• Study Start: January 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 11, 2021
• Results First Posted: June 28, 2016

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)