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

Brief Title

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

Official Title

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

Brief Summary

      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.
    

Detailed Description

      Surfactant dysfunction my contribute to the development of bronchopulmonary dysplasia (BPD)
      in persistently ventilated preterm infants. We 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 Phase

Phase 3

Study Type

Interventional

Primary Outcome

SP-B Content

Secondary Outcome

 Alive Without BPD at 36 Weeks Post Menstrual Age

Condition

Respiratory Distress Syndrome of Prematurity (Surfactant Dysfunction)

Intervention

Infasurf (ONY Inc.)

Study Arms / Comparison Groups

 Treatment Surfactant (Infasurf) ONY, NY

Description:  Patients receive inhaled nitric oxide and scheduled doses of Infasurf on study days 0, 3, 7, 10, and 14, if infant remains ventilated.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

85

Start Date

January 2008

Completion Date

December 2012

Primary Completion Date

December 2012

Eligibility Criteria

        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.
      

Gender

All

Ages

N/A - 14 Days

Accepts Healthy Volunteers

No

Contacts

Roberta A Ballard, MD, , 

Location Countries

United States

Location Countries

United States

NCT ID

NCT00569530

Organization ID

H10842-31630-01

Secondary IDs

IND79367

Responsible Party

Principal Investigator

Study Sponsor

University of California, San Francisco

Collaborators

 Mallinckrodt

Study Sponsor

Roberta A Ballard, MD, Principal Investigator, University of California, San Francisco

Verification Date

May 2016