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Completed

NCT Number: NCT01022580

Trial of Late Surfactant for Prevention of Bronchopulmonary Dysplasia

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.

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Key information

Conditions

Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Respiratory Tract Diseases Surfactant Dysfunction Urogenital Diseases Ventilator-Induced Lung Injury

Age range

7 day–14 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Arkansas - Arkansas Childrens Hospital, Little Rock, Arkansas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Infasurf surfactant (ONY, Inc.)

Drug

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 (No Treatment)

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Roberta Ballard

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Acronym: TOLSURF

Important dates

Study start
2010
Primary completion
2013
Study completion
2016
First posted
Dec 1, 2009
Registry last updated
May 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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