Trial of Late Surfactant for Prevention of Bronchopulmonary Dysplasia (TOLSURF)

April 21, 2021 updated by: Roberta Ballard

Trial of Late Surfactant for Prevention of Bronchopulmonary Dysplasia: A Study in Ventilated Preterm Infants Receiving Inhaled Nitric Oxide

The purpose of this study is to determine if late doses of Infasurf surfactant given when patients are receiving inhaled nitric oxide will interact to improve surfactant function and increase survival without BPD in treated infants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a multi-center, blinded, randomized controlled clinical trial to evaluate the effects of booster doses of exogenous surfactant (Infasurf®, calfactant) in addition to inhaled nitric oxide (iNO) on the outcome of survival without bronchopulmonary dysplasia (BPD, or chronic lung disease of prematurity, characterized by chronic lung dysfunction) at 36 weeks' post-menstrual age (PMA) in extremely low gestational age (ELGAN) infants that are at high risk of the development of BPD. This multi-center trial, with a planned enrollment of 524 infants, will also enable us to evaluate for any adverse effects of late surfactant treatment on short- and long-term outcomes, as we will be collecting data on effects of dosing of late surfactant, co-morbidities of prematurity and neurodevelopmental and pulmonary outcome at 1 year and 24 months corrected age. In addition, we will collect biological specimens for evaluation of the effects of late surfactant replacement therapy (administered as described in this trial) on surfactant function and inflammatory markers.

Study Type

Interventional

Enrollment (Actual)

511

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • University of Arkansas - Arkansas Childrens Hospital
    • California
      • Berkeley, California, United States, 94705
        • Alta Bates Medical Center
      • Oakland, California, United States, 94609
        • Oakland Children's Hospital
      • San Francisco, California, United States, 94143
        • University of California, San Francisco
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Wolfson Children's Hospital and Shands HospitaL
      • Orlando, Florida, United States, 32803
        • Florida Hospital for Children
      • Saint Petersburg, Florida, United States, 33701
        • All Children's Hospital
    • Illinois
      • Chicago, Illinois, United States, 60614
        • Children's Memorial Hospital
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Medical School
      • Minneapolis, Minnesota, United States, 55404
        • Childrens Hospital and Clinics of Minnesota- Minneapolis
      • Saint Paul, Minnesota, United States, 55102
        • Children's Hospital and Clinics of Minnesota - St Paul
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy Hospital
    • New York
      • Buffalo, New York, United States, 14222
        • Women's and Children's Hospital of Buffalo
      • Stony Brook, New York, United States, 11794
        • Stony Brook University Medical Center
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Wake Forest University- Forsyth Hospital and Brenner Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29403
        • Medical University of South Carolina(MUSC)
    • Tennessee
      • Memphis, Tennessee, United States, 38103-2807
        • UT Memphis- Memphis Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • Texas Children's Hospital
      • Houston, Texas, United States, 77030-1503
        • UT Houston Health Science Center
    • Washington
      • Seattle, Washington, United States, 98195-6320
        • University of Washington, Seattle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 week to 2 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • <=28 0/7 weeks gestational age
  • Day of life 7-14
  • Intubated and mechanically ventilated
  • Plan to treat with inhaled nitric oxide

Exclusion Criteria:

  • Serious congenital malformations or chromosomal abnormalities
  • Life expectancy <7 days from enrollment
  • Clinically unstable
  • Less tha 48 hours since last dose surfactant
  • Ability to obtain 36 week primary outcome information is unlikely

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Infasurf surfactant (ONY, Inc.)
Infants already receiving inhaled nitric oxide will receive scheduled doses of late surfactant (Infasurf) on study days 0, 2, 4, 6 and 8.
Drug: Infasurf surfactant (ONY, Inc.)
Late doses of Infasurf 3ml/kg will be given to infants on study days 0, 2, 4, 6 and 8 as long as infant remains intubated.
Other Names:
  • Treatment
Sham Comparator: Sham (No Treatment)
Infants already receiving inhaled nitric oxide will receive "Sham (no treatment)" doses on study days 0,2,4,6, and 8.
Drug: Sham (No Treatment)
Late doses of Sham (No treatment) will be given to infants on study days 0, 2, 4, 6 and 8 as long as infant remains intubated.
Other Names:
  • Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival Without BPD at 36 Weeks Post Menstrual Age.
Time Frame: 36 weeks post menstrual age +/- 1 week
BPD was diagnosed as need for respiratory support with either positive pressure and/or oxygen as evaluated by physiological oxygen/flow reduction.
36 weeks post menstrual age +/- 1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival Without BPD at 40 Weeks
Time Frame: 40 weeks PMA +/- 1 week
BPD was diagnosed as need for respiratory support with either positive pressure and/or oxygen as evaluated by physiological oxygen/flow reduction.
40 weeks PMA +/- 1 week
Respiratory Outcomes of TOLSURF Infants at 1 Year Corrected Age
Time Frame: 1 year
Evaluation of respiratory outcome through the first 12 months after birth. questionnaires were administered by phone at 3,6,9 and 12 months to determine respiratory resource use (medications, home support, and hospitalization) No Pulmonary Morbidity (NoPM) was reported for infants who had no resource use in any quarter and Persistent PM was reported for infants having resource use in 3 or 4 quarters.
1 year
Pulmonary Outcomes Through 2 Years of Age
Time Frame: 2 years
Evaluation of pulmonary outcome at 24 months of age. Evaluation of persistent wheezing based on reported wheezing during both first and second year of life.
2 years
Percentage of Participants With Neurodevelopmental Impairment (NDI) at 2 Years.
Time Frame: 2 years
At 24 months corrected age, children underwent neuropsychological testing with the Bayley Scales of Infant Development-Third Edition (Bayley-3), and composite cognitive, language, and motor scores were collected as well as subscale scores in receptive and expressive speech and fine and gross motor. Infants with greater than one impairment as identified by testing were classified as having neurodevelopmental impairment.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Roberta Ballard

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

November 19, 2009

First Submitted That Met QC Criteria

November 30, 2009

First Posted (Estimate)

December 1, 2009

Study Record Updates

Last Update Posted (Actual)

May 13, 2021

Last Update Submitted That Met QC Criteria

April 21, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H10842-33541-01A
  • U01HL094338 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bronchopulmonary Dysplasia

Clinical Trials on Infasurf surfactant (ONY, Inc.)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Italy

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe