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Non Inferiority Trial Investigating Surfactants Administered Via MIST (Niftisurf)

Primary Purpose

Respiratory Distress Syndrome

Status
Not yet recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
MIST surfactant
Sponsored by
NorthShore University HealthSystem
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Distress Syndrome focused on measuring Pulmonary Surfactant, CPAP, Neonate

Eligibility Criteria

undefined - 48 Hours (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Northshore University Healthsystem

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Calfactant (Infasurf)

Poractant alfa (Curosurf)

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Duration of positive pressure support
Endotracheal ventilation or Non-invasive Ventilation or CPAP or NC flow>2 L
Duration of Supplemental oxygen
Oxygen requirement to keep saturations >95%

Full Information

First Posted
September 27, 2023
Last Updated
September 27, 2023
Sponsor
NorthShore University HealthSystem
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1. Study Identification

Unique Protocol Identification Number
NCT06074380
Brief Title
Non Inferiority Trial Investigating Surfactants Administered Via MIST
Acronym
Niftisurf
Official Title
Non Inferiority Trial Investigating Surfactants Administered Via MIST
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
October 30, 2025 (Anticipated)
Study Completion Date
December 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
NorthShore University HealthSystem

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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 on NCPAP and FiO2 ≥0.30 will randomized to curosuf 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.
Detailed Description
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 confirmed by a chest x-ray. Infants who on NCPAP and FiO2 ≥0.30 will randomized to Infasurf of Curosurf 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. . 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. OUTCOMES Primary outcome: Intubation in the first 7 days of age. Secondary outcomes: Respiratory Number of doses of surfactant, Incidence of composite outcome of death or physiological bronchopulmonary dysplasia (BPD). Durations of mechanical respiratory support, CPAP, high flow nasal cannula, (HFNC), oxygen therapy. Pneumothorax or pulmonary hemorrhage. Non respiratory neonatal morbidities intraventricular hemorrhage, periventricular leukomalacia, retinopathy of prematurity, necrotising enterocolitis, and patent ductus arteriosus. Corrected age at discharge, length of hospital stay (a proxy for cost). The above data will be collected until discharge. SAMPLE SIZE With intubation with 7 days as the primary outcome, assuming a baseline of 75% avoiding intubation a total of 262 babies would be needed with an inferiority margin of 15%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome
Keywords
Pulmonary Surfactant, CPAP, Neonate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
ParticipantInvestigator
Masking Description
Surfactant will be sent from Investigational Pharmacy
Allocation
Randomized
Enrollment
262 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Calfactant (Infasurf)
Arm Type
Experimental
Arm Description
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
Arm Title
Poractant alfa (Curosurf)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
MIST surfactant
Intervention Description
Surfactant will be given via MIST while neonate is on CPAP
Primary Outcome Measure Information:
Title
Endotracheal Intubation
Description
Infants will have an endotracheal placed if their inspired oxygen is >45% for more than 15 minutes
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Duration of positive pressure support
Description
Endotracheal ventilation or Non-invasive Ventilation or CPAP or NC flow>2 L
Time Frame
36 weeks corrected gestational age
Title
Duration of Supplemental oxygen
Description
Oxygen requirement to keep saturations >95%
Time Frame
36 weeks corrected gestational age

10. Eligibility

Sex
All
Maximum Age & Unit of Time
48 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew Derrick
Phone
18475702920
Email
mderrick@northshore.org
Facility Information:
Facility Name
Northshore University Healthsystem
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20084586
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.
Results Reference
background
PubMed Identifier
34902013
Citation
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.
Results Reference
result

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Non Inferiority Trial Investigating Surfactants Administered Via MIST

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