Clinical trial NCT00569530: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Respiratory Distress Syndrome of Prematurity (Surfactant Dysfunction)
Bronchopulmonary Dysplasia
Keywords: nitric oxide
surfactant
bronchopulmonary dysplasia
prematurity
neonates
iNO
Infasurf
lung function
ventilated infants
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Mallinckrodt
name: ONY
First posted: 2007-12-07
Enrollment: 85
Sex: ALL
Minimum age (years): 7
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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.

Primary outcomes:
measure: SP-B Content
timeFrame: One day after dose
Secondary outcomes:
measure: Alive Without BPD at 36 Weeks Post Menstrual Age
timeFrame: 36 Weeks Post Menstrual Age
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: Alta Bates Summit Medical Center
state: California
city: Oakland
country: United States
facility: Children's Hospital Oakland
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Chicago
country: United States
facility: Children's Memorial Hospital
state: Illinois
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
city: Buffalo
country: United States
facility: Women and Children's Hospital of Buffalo
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: University of California, San Francisco
name: Roberta A Ballard, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ballard RA, Truog WE, Cnaan A, Martin RJ, Ballard PL, Merrill JD, Walsh MC, Durand DJ, Mayock DE, Eichenwald EC, Null DR, Hudak ML, Puri AR, Golombek SG, Courtney SE, Stewart DL, Welty SE, Phibbs RH, Hibbs AM, Luan X, Wadlinger SR, Asselin JM, Coburn CE; NO CLD Study Group. Inhaled nitric oxide in preterm infants undergoing mechanical ventilation. N Engl J Med. 2006 Jul 27;355(4):343-53. doi: 10.1056/NEJMoa061088.
citation: Ballard PL, Merrill JD, Truog WE, Godinez RI, Godinez MH, McDevitt TM, Ning Y, Golombek SG, Parton LA, Luan X, Cnaan A, Ballard RA. Surfactant function and composition in premature infants treated with inhaled nitric oxide. Pediatrics. 2007 Aug;120(2):346-53. doi: 10.1542/peds.2007-0095.
citation: Truog WE, Ballard PL, Norberg M, Golombek S, Savani RC, Merrill JD, Parton LA, Cnaan A, Luan X, Ballard RA; Nitric Oxide (to Prevent) Chronic Lung Disease Study Investigators. Inflammatory markers and mediators in tracheal fluid of premature infants treated with inhaled nitric oxide. Pediatrics. 2007 Apr;119(4):670-8. doi: 10.1542/peds.2006-2683.
citation: Keller RL, Merrill JD, Black DM, Steinhorn RH, Eichenwald EC, Durand DJ, Ryan RM, Truog WE, Courtney SE, Ballard PL, Ballard RA. Late administration of surfactant replacement therapy increases surfactant protein-B content: a randomized pilot study. Pediatr Res. 2012 Dec;72(6):613-9. doi: 10.1038/pr.2012.136. Epub 2012 Oct 4.