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

Primary Purpose

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

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Infasurf (ONY Inc.)
Sham
Sponsored by
Roberta Ballard
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Distress Syndrome of Prematurity (Surfactant Dysfunction) focused on measuring nitric oxide, surfactant, bronchopulmonary dysplasia, prematurity, neonates, iNO, Infasurf, lung function, ventilated infants

Eligibility Criteria

7 Days - 14 Days (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Alta Bates Summit Medical Center
  • Children's Hospital Oakland
  • University of California, San Francisco
  • Northwestern Memorial Hospital
  • Children's Memorial Hospital
  • Children's Mercy Hospital
  • Women and Children's Hospital of Buffalo
  • Stony Brook University Medical Center
  • Texas Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Treatment Surfactant (Infasurf) ONY, NY

Sham (no treatment)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Alive Without BPD at 36 Weeks Post Menstrual Age
Alive without need for oxygen at 36 weeks post menstrual age.

Full Information

First Posted
December 5, 2007
Last Updated
April 21, 2021
Sponsor
Roberta Ballard
Collaborators
Mallinckrodt, ONY
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1. Study Identification

Unique Protocol Identification Number
NCT00569530
Brief Title
Trial of Late Surfactant to Prevent BPD: A Pilot Study in Ventilated Preterm Neonates Receiving Inhaled Nitric Oxide
Acronym
TOLSURFPilot
Official Title
Trial of Late Surfactant to Prevent BPD: A Pilot Study in Ventilated Preterm Neonates Receiving Inhaled Nitric Oxide
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Roberta Ballard
Collaborators
Mallinckrodt, ONY

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome of Prematurity (Surfactant Dysfunction), Bronchopulmonary Dysplasia
Keywords
nitric oxide, surfactant, bronchopulmonary dysplasia, prematurity, neonates, iNO, Infasurf, lung function, ventilated infants

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Surfactant (Infasurf) ONY, NY
Arm Type
Active Comparator
Arm Description
Patients receive inhaled nitric oxide and scheduled doses of Infasurf on study days 0, 3, 7, 10, and 14, if infant remains ventilated.
Arm Title
Sham (no treatment)
Arm Type
Placebo Comparator
Arm Description
Infants receiving inhaled nitric oxide will receive Sham (no treatment) on study days 0, 3, 7, 10, and 14, if infant remains ventilated.
Intervention Type
Drug
Intervention Name(s)
Infasurf (ONY Inc.)
Other Intervention Name(s)
Infasurf
Intervention Description
Infasurf 3ml/kg will be given to infants on study days 0, 3, 7, 10, and 14, if remains intubated.
Intervention Type
Drug
Intervention Name(s)
Sham
Other Intervention Name(s)
Air
Intervention Description
Sham instillation (no treatment) will be given to study infants on days 0, 3, 7, 10, and 14, if remains intubated.
Primary Outcome Measure Information:
Title
SP-B Content
Description
SP-B Content is the surfactant protein B found in terms of percentage of phospholipid measured one day after surfactant or sham dose.
Time Frame
One day after dose
Secondary Outcome Measure Information:
Title
Alive Without BPD at 36 Weeks Post Menstrual Age
Description
Alive without need for oxygen at 36 weeks post menstrual age.
Time Frame
36 Weeks Post Menstrual Age

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Days
Maximum Age & Unit of Time
14 Days
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberta A Ballard, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alta Bates Summit Medical Center
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Name
Children's Hospital Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Children's Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Women and Children's Hospital of Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14222
Country
United States
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16870913
Citation
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. Erratum In: N Engl J Med. 2007 Oct 4;357(14):1444-5.
Results Reference
background
PubMed Identifier
17671061
Citation
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.
Results Reference
background
PubMed Identifier
17403837
Citation
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.
Results Reference
background
PubMed Identifier
23037875
Citation
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.
Results Reference
background

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

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