Non Inferiority Trial Investigating Surfactants Administered Via MIST

Respiratory Distress Syndrome Clinical Trial

— Niftisurf  

Official title:

Non Inferiority Trial Investigating Surfactants Administered Via MIST

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06074380
• Other study ID #: EH23-232
• Status: Recruiting
• Phase: Phase 4
• Start date: January 1, 2024
• Est. completion date: December 1, 2027

Study information

• Verified date: February 2024
• Source: NorthShore University HealthSystem
• Contact: Matthew Derrick
• Phone: 18475702920
• Email: mderrick[@]northshore.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

INTERVENTION Infants who on CPAP who reach the threshold of 30% oxygen will be randomized to calfactant (Infasurf), 3ml/kg or poractant alfa (Curosurf), 2.5ml/kg, administered under direct laryngoscopy using a surfactant instillation catheter (MIST) 16G Angiocath (Becton Dickinson, Sandy, UT, USA).

A second dose of calfactant (Infasurf) 3ml/kg or poractant alfa (Curosurf), 1.25ml/kg, will be administered via MIST their fiO2 reaches the threshold of 30% between 6 and 48 hours after the first dose.

No further surfactant should be given in the first 7 days unless the infant reaches the intubation criteria.

POST-INTERVENTION MANAGEMENT Other than the requirement to adhere to intubation criteria in the first week, and in some cases perform a room air trial at 36 weeks corrected gestation, management will be at the discretion of the clinical team.

Titration of CPAP pressure is encouraged, with a permitted maximum of 8 cm H2O. Use of nasal IPPV is allowable for apnea, but discouraged for RDS and should only be after at least one dose of surfactant has been given. Early caffeine therapy is expected.

Criteria for intubation:

Enrolled infants on CPAP will be intubated if:

• FiO2 ≥0.45 for 15 minutes, or if there is unremitting apnea (> 6 episodes/hour requiring intervention or in the opinion of the treating physician) or persistent respiratory acidosis (pH<7.25 and pCO2 >60) on blood gasses at least 30 minutes apart or metabolic acidosis refractory to treatment.

• Need for an anesthetic or an intervention requiring intubation

These criteria apply during the first week of life, and to the first episode of intubation only. If the infant is intubated it is expected that another dose of surfactant will be administered.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 262
• Est. completion date: December 1, 2027
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 48 Hours

Eligibility

Inclusion 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 confirmed by a chest x-ray on nasal continuous positive airway pressure (NCPAP) and FiO2 =0.30

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

Drug:
• MIST surfactant
Surfactant will be given via MIST while neonate is on CPAP

Locations

Country	Name	City	State
United States	Northshore University Healthsystem	Evanston	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
NorthShore University HealthSystem

Country where clinical trial is conducted

United States, 

References & 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, — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Duration of positive pressure support	Endotracheal ventilation or Non-invasive Ventilation or CPAP or NC flow>2 L	36 weeks corrected gestational age
Secondary	Duration of Supplemental oxygen	Oxygen requirement to keep saturations >95%	36 weeks corrected gestational age