Non Inferiority Trial Investigating Surfactants Administered Via MIST

NCT06074380 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: EH23-232
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 1

Brief Summary

RESEARCH DESIGN Multicenter, randomized, controlled trial. RECRUITMENT Entry criteria Preterm infants 28-35 6/7 weeks' gestation and less than 48 hours of age who have a clinical diagnosis of respiratory distress syndrome. Infants who are on NCPAP and FiO2 ≥0.30 will randomized to curosurf or infasurf via MIST. Exclusion criteria Infants will be excluded if there is a congenital anomaly or an alternative cause for respiratory distress. Babies who require emergent intubation will not be enrolled in the interventions. Parental Consent will be obtained prior to randomization.

Conditions

Respiratory Distress Syndrome

Keywords

Pulmonary Surfactant; CPAP; Neonate

Outcome Measures

Primary Outcomes (1)

• Number of infants requiring Endotracheal Intubation

  Infants will have an endotracheal placed if their inspired oxygen is \>45% for more than 15 minutes

  7 days

Secondary Outcomes (2)

• Duration of positive pressure support

  36 weeks corrected gestational age

• Duration of Supplemental oxygen

  36 weeks corrected gestational age

Study Arms (2)

Calfactant (Infasurf)

EXPERIMENTAL

Neonate, 28-35 weeks gestation, less than 48 hours of age, with respiratory distress syndrome on CPAP \> 30% oxygen will be given 3ml/kg of Calfacant

Drug: MIST surfactant

Poractant alfa (Curosurf)

EXPERIMENTAL

Neonate, 28-35 weeks gestation, less than 48 hours of age, with respiratory distress syndrome on CPAP \> 30% oxygen will be given 2.5ml/kg of Poractant alfa.

Drug: MIST surfactant

Interventions

MIST surfactant DRUG

Surfactant will be given via MIST while neonate is on CPAP

Calfactant (Infasurf); Poractant alfa (Curosurf)

Eligibility Criteria

• Age: Up to 48 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infants 28-35 6/7 weeks' gestation and less than 48 hours of age who have a clinical diagnosis of respiratory distress syndrome confirmed by a chest x-ray on nasal continuous positive airway pressure (NCPAP) and FiO2 ≥0.30

You may not qualify if:

• Infants will be excluded if there is a congenital anomaly or an alternative cause for respiratory distress.
• Infants who require emergent intubation will not be enrolled in the interventions.

Sponsors & Collaborators

• Endeavor Health: lead

Study Sites (1)

Northshore University Healthsystem

Evanston, Illinois, 60201, United States

RECRUITING

Related Publications (2)

• Dargaville PA, Kamlin COF, Orsini F, Wang X, De Paoli AG, Kanmaz Kutman HG, Cetinkaya M, Kornhauser-Cerar L, Derrick M, Ozkan H, Hulzebos CV, Schmolzer GM, Aiyappan A, Lemyre B, Kuo S, Rajadurai VS, O'Shea J, Biniwale M, Ramanathan R, Kushnir A, Bader D, Thomas MR, Chakraborty M, Buksh MJ, Bhatia R, Sullivan CL, Shinwell ES, Dyson A, Barker DP, Kugelman A, Donovan TJ, Tauscher MK, Murthy V, Ali SKM, Yossuck P, Clark HW, Soll RF, Carlin JB, Davis PG; OPTIMIST-A Trial Investigators. Effect of Minimally Invasive Surfactant Therapy vs Sham Treatment on Death or Bronchopulmonary Dysplasia in Preterm Infants With Respiratory Distress Syndrome: The OPTIMIST-A Randomized Clinical Trial. JAMA. 2021 Dec 28;326(24):2478-2487. doi: 10.1001/jama.2021.21892.

  PMID: 34902013 BACKGROUND

• Kribs A, Hartel C, Kattner E, Vochem M, Kuster H, Moller J, Muller D, Segerer H, Wieg C, Gebauer C, Nikischin W, Wense Av, Herting E, Roth B, Gopel W. Surfactant without intubation in preterm infants with respiratory distress: first multi-center data. Klin Padiatr. 2010 Jan-Feb;222(1):13-7. doi: 10.1055/s-0029-1241867. Epub 2010 Jan 18.

  PMID: 20084586 BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Central Study Contacts

Matthew Derrick

CONTACT

18475702920; mderrick@northshore.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Surfactant will be sent from Investigational Pharmacy
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Neonatologist

Model Details: Comparison of the efficacy of calfactant compared to poractant alfa administered with a minimally invasive method for the treatment of respiratory distress syndrome in 28-36 week infants

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 10, 2023
• Study Start: January 1, 2024
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)