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Bronchopulmonary DysplasiaPhase 3TOLSURFNCT01022580

Trial of Late Surfactant for Prevention of Bronchopulmonary Dysplasia

A Phase 3 study testing Infasurf surfactant (ONY, Inc.) in people with Bronchopulmonary Dysplasia, run by Roberta Ballard at 21 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 7 to 14 days
Conditions the study is for
Bronchopulmonary Dysplasia
What is being tested?
Infasurf surfactant (ONY, Inc.)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
511 participants
Where
21 sitesUnited States
Study dates
Jan 2010to Jan 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 14 days
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

United States21 sites

  • Alta Bates Medical Center

    Berkeley, California, 94705

  • Women's and Children's Hospital of Buffalo

    Buffalo, New York, 14222

  • Medical University of South Carolina(MUSC)

    Charleston, South Carolina, 29403

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • Children's Memorial Hospital

    Chicago, Illinois, 60614

  • UT Houston Health Science Center

    Houston, Texas, 77030-1503

  • Texas Children's Hospital

    Houston, Texas, 77030

  • Wolfson Children's Hospital and Shands HospitaL

    Jacksonville, Florida, 32207

  • Children's Mercy Hospital

    Kansas City, Missouri, 64108

  • University of Arkansas - Arkansas Childrens Hospital

    Little Rock, Arkansas, 72202

  • UT Memphis- Memphis Medical Center

    Memphis, Tennessee, 38103-2807

  • Childrens Hospital and Clinics of Minnesota- Minneapolis

    Minneapolis, Minnesota, 55404

  • University of Minnesota Medical School

    Minneapolis, Minnesota, 55455

  • Oakland Children's Hospital

    Oakland, California, 94609

  • Florida Hospital for Children

    Orlando, Florida, 32803

  • Children's Hospital and Clinics of Minnesota - St Paul

    Saint Paul, Minnesota, 55102

  • University of California, San Francisco

    San Francisco, California, 94143

  • University of Washington, Seattle

    Seattle, Washington, 98195-6320

  • All Children's Hospital

    St. Petersburg, Florida, 33701

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

  • Wake Forest University- Forsyth Hospital and Brenner Hospital

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Infasurf surfactant (ONY, Inc.), Sham (No Treatment)
Keywords
nitric oxide, surfactant, BPD, prematurity, neonates, iNO, pulmonary outcome, neurodevelopmental outcome, Infasurf, lung function, Surfactant Dysfunction, Bronchopulmonary Dysplasia
Medical subject headings
Bronchopulmonary Dysplasia, Premature Birth, Surfactant Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Infasurf surfactant (ONY, Inc.)Drug

    Also called Treatment

    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.

  • Sham (No Treatment)Drug

    Also called Control

    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.

Study groups in NCT01022580
Study groupRoleWhat they receive
Infasurf surfactant (ONY, Inc.)Active comparatorInfants already receiving inhaled nitric oxide will receive scheduled doses of late surfactant (Infasurf) on study days 0, 2, 4, 6 and 8.
Receives: Drug: Infasurf surfactant (ONY, Inc.)
Sham (No Treatment)Sham comparatorInfants already receiving inhaled nitric oxide will receive "Sham (no treatment)" doses on study days 0,2,4,6, and 8.
Receives: Drug: Sham (No Treatment)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Survival Without BPD at 36 Weeks Post Menstrual Age.

    BPD was diagnosed as need for respiratory support with either positive pressure and/or oxygen as evaluated by physiological oxygen/flow reduction.

    Measured: 36 weeks post menstrual age +/- 1 week

Secondary outcomes (4)

  1. Survival Without BPD at 40 Weeks

    BPD was diagnosed as need for respiratory support with either positive pressure and/or oxygen as evaluated by physiological oxygen/flow reduction.

    Measured: 40 weeks PMA +/- 1 week

  2. Respiratory Outcomes of TOLSURF Infants at 1 Year Corrected Age

    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.

    Measured: 1 year

  3. Pulmonary Outcomes Through 2 Years of Age

    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.

    Measured: 2 years

  4. Percentage of Participants With Neurodevelopmental Impairment (NDI) at 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.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2009 (estimated)
  2. Study startJan 2010
  3. Primary completionDec 2013
  4. Study completionJan 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
511 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01022580
Sponsor's protocol ID
H10842-33541-01A
Other IDs
U01HL094338
Acronym
TOLSURF
Status last verified
Apr 2021
First submitted
19 Nov 2009
Last updated
13 May 2021
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 16870913

  • 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.

    PubMed 17671061

  • 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.

    PubMed 17403837

  • Ballard RA, Keller RL, Black DM, Ballard PL, Merrill JD, Eichenwald EC, Truog WE, Mammel MC, Steinhorn RH, Rogers EE, Ryan RM, Durand DJ, Asselin JM, Bendel CM, Bendel-Stenzel EM, Courtney SE, Dhanireddy R, Hudak ML, Koch FR, Mayock DE, McKay VJ, O'Shea TM, Porta NF, Wadhawan R, Palermo L; TOLSURF Study Group. Randomized Trial of Late Surfactant Treatment in Ventilated Preterm Infants Receiving Inhaled Nitric Oxide. J Pediatr. 2016 Jan;168:23-29.e4. doi: 10.1016/j.jpeds.2015.09.031. Epub 2015 Oct 21.

    PubMed 26500107

  • Wai KC, Hibbs AM, Steurer MA, Black DM, Asselin JM, Eichenwald EC, Ballard PL, Ballard RA, Keller RL; Trial of Late Surfactant (TOLSURF) Study Group. Maternal Black Race and Persistent Wheezing Illness in Former Extremely Low Gestational Age Newborns: Secondary Analysis of a Randomized Trial. J Pediatr. 2018 Jul;198:201-208.e3. doi: 10.1016/j.jpeds.2018.02.032. Epub 2018 Apr 4.

    PubMed 29627188

  • Keller RL, Eichenwald EC, Hibbs AM, Rogers EE, Wai KC, Black DM, Ballard PL, Asselin JM, Truog WE, Merrill JD, Mammel MC, Steinhorn RH, Ryan RM, Durand DJ, Bendel CM, Bendel-Stenzel EM, Courtney SE, Dhanireddy R, Hudak ML, Koch FR, Mayock DE, McKay VJ, Helderman J, Porta NF, Wadhawan R, Palermo L, Ballard RA; TOLSURF Study Group. The Randomized, Controlled Trial of Late Surfactant: Effects on Respiratory Outcomes at 1-Year Corrected Age. J Pediatr. 2017 Apr;183:19-25.e2. doi: 10.1016/j.jpeds.2016.12.059. Epub 2017 Jan 16.

    PubMed 28100402

  • Wai KC, Keller RL, Lusk LA, Ballard RA, Chan DK; Trial of Late Surfactant (TOLSURF) Study Group. Characteristics of Extremely Low Gestational Age Newborns Undergoing Tracheotomy: A Secondary Analysis of the Trial of Late Surfactant Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2017 Jan 1;143(1):13-19. doi: 10.1001/jamaoto.2016.2428.

    PubMed 27583380

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Infasurf surfactant (ONY, Inc.) in people with Bronchopulmonary Dysplasia, run by Roberta Ballard at 21 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival Without BPD at 36 Weeks Post Menstrual Age. (time frame: 36 weeks post menstrual age +/- 1 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01022580, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2021.

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