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Completed

NCT Number: NCT00569530

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

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.

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Key information

Conditions

Respiratory Distress Syndrome of Prematurity (Surfactant Dysfunction) 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 Respiration Disorders Respiratory Distress Syndrome 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

Alta Bates Summit Medical Center, Berkeley, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Infasurf (ONY Inc.)

Drug

Infasurf 3ml/kg will be given to infants on study days 0, 3, 7, 10, and 14, if remains intubated.

Other names: Infasurf

sham

Drug

Sham instillation (no treatment) will be given to study infants on days 0, 3, 7, 10, and 14, if remains intubated.

Other names: Air

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Roberta Ballard

Other

Collaborators

  • Mallinckrodt
  • ONY

Registry information

Acronym: TOLSURFPilot

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Dec 7, 2007
Registry last updated
May 11, 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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