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

April 21, 2021 updated by: Roberta Ballard
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

85

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
    • California
      • Berkeley, California, United States, 94705
        • Alta Bates Summit Medical Center
      • Oakland, California, United States, 94609
        • Children's Hospital Oakland
      • San Francisco, California, United States, 94143
        • University of California, San Francisco
    • Illinois
      • Chicago, Illinois, United States, 60614
        • Children's Memorial Hospital
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy Hospital
    • New York
      • Buffalo, New York, United States, 14222
        • Women and Children's Hospital of Buffalo
      • Stony Brook, New York, United States, 11794
        • Stony Brook University Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • Texas Children's Hospital

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:

  • 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.

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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.
Drug: Infasurf (ONY Inc.)
Infasurf 3ml/kg will be given to infants on study days 0, 3, 7, 10, and 14, if remains intubated.
Other Names:
  • Infasurf
PLACEBO_COMPARATOR: 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.
Drug: Sham
Sham instillation (no treatment) will be given to study infants on days 0, 3, 7, 10, and 14, if remains intubated.
Other Names:
  • Air

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SP-B Content
Time Frame: One day after dose
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alive Without BPD at 36 Weeks Post Menstrual Age
Time Frame: 36 Weeks Post Menstrual Age
Alive without need for oxygen at 36 weeks post menstrual age.
36 Weeks Post Menstrual Age

Collaborators and Investigators

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

Sponsor

Roberta Ballard

Collaborators

Mallinckrodt
ONY

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, 2008

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

December 5, 2007

First Submitted That Met QC Criteria

December 6, 2007

First Posted (ESTIMATE)

December 7, 2007

Study Record Updates

Last Update Posted (ACTUAL)

May 11, 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

  • H10842-31630-01
  • IND79367 (OTHER: FDA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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