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

Roberta Ballard

Status and phase: Completed; Phase 3

Conditions: Bronchopulmonary Dysplasia

Treatments: Drug: Infasurf surfactant (ONY, Inc.); Drug: Sham (No Treatment)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01022580

H10842-33541-01A

U01HL094338 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 511 patients

Sex: All

Ages: 7 to 14 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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511 participants in 2 patient groups

Infasurf surfactant (ONY, Inc.)

Active Comparator group

Description:

Infants already receiving inhaled nitric oxide will receive scheduled doses of late surfactant (Infasurf) on study days 0, 2, 4, 6 and 8.

Treatment:

Drug: Infasurf surfactant (ONY, Inc.)

Sham (No Treatment)

Sham Comparator group

Description:

Infants already receiving inhaled nitric oxide will receive "Sham (no treatment)" doses on study days 0,2,4,6, and 8.

Treatment:

Drug: Sham (No Treatment)