Prophylactic Minimally Invasive Surfactant Evaluation

NCT06007547 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: EH23-107
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to explore the question: Does prophylactic administration of exogenous surfactant in the delivery room, using a minimally-invasive technique, improve outcome in preterm infants 22-29 weeks' gestation compared to rescue treatment using the same technique?

Conditions

Respiratory Distress Syndrome, Newborn; Premature Birth

Keywords

Respiratory Distress Syndrome; surfactant; Minimally invasive Surfactant Therapy

Outcome Measures

Primary Outcomes (1)

• Endotracheal Intubation

  Oxygen requirement \> 45% requiring endotracheal intubation

  7 days

Secondary Outcomes (1)

• Bronchopulmonary dysplasia

  36 weeks corrected gestational age

Study Arms (2)

Prophylactic Surfactant via Minimally Invasive Technique

EXPERIMENTAL

Infants randomized to prophylactic surfactant treatment will receive a dose of poractant alfa (Curosurf) administered under direct laryngoscopy using a surfactant instillation catheter (MIST) 16G Angiocath (Becton Dickinson, Sandy, UT, USA), at a dosage of 200 mg/kg as soon as possible after delivery (within 15 minutes).

Drug: Poractant Alfa

Rescue Surfactant via Minimally Invasive Technique

ACTIVE COMPARATOR

The control group will be given surfactant will receive a dose of poractant alfa (Curosurf) administered under direct laryngoscopy using a surfactant instillation catheter (MIST) 16G Angiocath (Becton Dickinson, Sandy, UT, USA), at a dosage of 200 mg/kg if their fiO2 reaches a threshold of ≥30% within the first 48 hours of life.

Drug: Poractant Alfa

Interventions

Poractant Alfa DRUG

Poractant alfa (Curosurf) 200mg/kg administered under direct laryngoscopy using a surfactant instillation catheter

Also known as: Minimally Invasive Surfactant Therapy

Prophylactic Surfactant via Minimally Invasive Technique; Rescue Surfactant via Minimally Invasive Technique

Eligibility Criteria

• Age: Up to 15 Minutes
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Gestational age \<30 weeks
• Antenatal consent from Parent

You may not qualify if:

• Congenital anomalies
• Alternate cause of respiratory distress

Sponsors & Collaborators

• Endeavor Health: lead
• Chiesi USA, Inc.: collaborator

Study Sites (1)

Northshore University Healthsystem

Evanston, Illinois, 60201, United States

RECRUITING

Related Publications (5)

• 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

• Kendig JW, Notter RH, Cox C, Reubens LJ, Davis JM, Maniscalco WM, Sinkin RA, Bartoletti A, Dweck HS, Horgan MJ, et al. A comparison of surfactant as immediate prophylaxis and as rescue therapy in newborns of less than 30 weeks' gestation. N Engl J Med. 1991 Mar 28;324(13):865-71. doi: 10.1056/NEJM199103283241301.

  PMID: 2000109 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

• Kattwinkel J, Bloom BT, Delmore P, Davis CL, Farrell E, Friss H, Jung AL, King K, Mueller D. Prophylactic administration of calf lung surfactant extract is more effective than early treatment of respiratory distress syndrome in neonates of 29 through 32 weeks' gestation. Pediatrics. 1993 Jul;92(1):90-8.

  PMID: 8516091 BACKGROUND

• SUPPORT Study Group of the Eunice Kennedy Shriver NICHD Neonatal Research Network; Finer NN, Carlo WA, Walsh MC, Rich W, Gantz MG, Laptook AR, Yoder BA, Faix RG, Das A, Poole WK, Donovan EF, Newman NS, Ambalavanan N, Frantz ID 3rd, Buchter S, Sanchez PJ, Kennedy KA, Laroia N, Poindexter BB, Cotten CM, Van Meurs KP, Duara S, Narendran V, Sood BG, O'Shea TM, Bell EF, Bhandari V, Watterberg KL, Higgins RD. Early CPAP versus surfactant in extremely preterm infants. N Engl J Med. 2010 May 27;362(21):1970-9. doi: 10.1056/NEJMoa0911783. Epub 2010 May 16.

  PMID: 20472939 BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome, Newborn; Premature Birth; Respiratory Distress Syndrome

Interventions

poractant alfa

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Matthew Derrick, MBBS

  Northshore Univ Healthsystem

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Derrick, MBBS

CONTACT

8475702920; mderrick@northshore.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Neonatologist

Model Details: Comparison of prophylaxis compared to rescue surfactant, administered using a minimally invasive technique, in premature infants less that 30 weeks gestation

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: August 23, 2023
• Study Start: January 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): July 31, 2027
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)