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

NCT ID: NCT00569530

Last Updated: 2021-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2012-12-31

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.

Detailed Description

Surfactant dysfunction may contribute to the development of bronchopulmonary dysplasia (BPD) in persistently ventilated preterm infants. The investigators conducted a multi-center, randomized, blinded pilot study to assess the safety and efficacy of late administration of surfactant (Calfactant - high in protein B) in combination with prolonged inhaled nitric oxide in preterm infants < 1000 grams birthweight (BW). Calfactant is one of several types of exogenous surfactant. Calfactant has the highest % of surfactant protein B of the different types.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment Surfactant (Infasurf) ONY, NY

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

Group Type: ACTIVE_COMPARATOR

Infasurf (ONY Inc.)

Intervention Type: DRUG

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

Sham (no treatment)

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

Group Type: PLACEBO_COMPARATOR

Sham

Intervention Type: DRUG

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

Interventions

Infasurf (ONY Inc.)

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

Intervention Type: DRUG

Sham

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

Intervention Type: DRUG

Other Intervention Names

Infasurf; Air

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 7 Days
• Maximum Eligible Age: 14 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mallinckrodt

INDUSTRY

Sponsor Role: collaborator

ONY

INDUSTRY

Sponsor Role: collaborator

Roberta Ballard

OTHER

Sponsor Role: lead

Responsible Party

Roberta Ballard

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Roberta A Ballard, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

Alta Bates Summit Medical Center

Berkeley, California, United States

Children's Hospital Oakland

Oakland, California, United States

University of California, San Francisco

San Francisco, California, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

Children's Memorial Hospital

Chicago, Illinois, United States

Children's Mercy Hospital

Kansas City, Missouri, United States

Women and Children's Hospital of Buffalo

Buffalo, New York, United States

Stony Brook University Medical Center

Stony Brook, New York, United States

Texas Children's Hospital

Houston, Texas, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 16870913 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17671061 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17403837 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23037875 (View on PubMed)

Other Identifiers

IND79367

Identifier Type: OTHER

Identifier Source: secondary_id

H10842-31630-01

Identifier Type: -

Identifier Source: org_study_id