Respiratory Distress SyndromePhase 4NiftisurfNCT06074380
Non Inferiority Trial Investigating Surfactants Administered Via MIST
A Phase 4 study testing MIST surfactant in people with Respiratory Distress Syndrome, run by Endeavor Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 48 hours
- Conditions the study is for
- Respiratory Distress Syndrome
- What is being tested?
- MIST surfactant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2024to 1 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 48 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northshore University Healthsystem
Evanston, Illinois, 60201
Matthew Derrick, mbbs, 8475702920, mderrick@northshore.org
About this study
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.
Read the detailed 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.
- Conditions
- Respiratory Distress Syndrome
- Being tested
- MIST surfactant
- Keywords
- Pulmonary Surfactant, CPAP, Neonate
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIST surfactantDrug
Surfactant will be given via MIST while neonate is on CPAP
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: MIST surfactant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of infants requiring Endotracheal Intubation
Infants will have an endotracheal placed if their inspired oxygen is >45% for more than 15 minutes
Measured: 7 days
Secondary outcomes (2)
Duration of positive pressure support
Endotracheal ventilation or Non-invasive Ventilation or CPAP or NC flow>2 L
Measured: 36 weeks corrected gestational age
Duration of Supplemental oxygen
Oxygen requirement to keep saturations >95%
Measured: 36 weeks corrected gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start1 Jan 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 262 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Derrick, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06074380
- Sponsor's protocol ID
- EH23-232
- Acronym
- Niftisurf
- Status last verified
- Aug 2025
- First submitted
- 27 Sep 2023
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20084586Dargaville 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.
PubMed 34902013
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Inferiority Trial Investigating Surfactants Administered Via MIST
- ClinicalTrials.gov ID
- NCT06074380
- Acronym / sponsor ID
- Niftisurf / EH23-232
- Conditions
- Respiratory Distress Syndrome
- Keywords
- Pulmonary Surfactant, CPAP, Neonate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 262 participants (estimated)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Calfactant (Infasurf) | Experimental | Drug: MIST surfactantNeonate, 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 |
| Poractant alfa (Curosurf) | Experimental | Drug: MIST surfactantNeonate, 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. |
Who may qualify
- Ages
- Up to 48 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MIST surfactantSurfactant will be given via MIST while neonate is on CPAP | Drug | Calfactant (Infasurf), Poractant alfa (Curosurf) |
Primary outcome
Number of infants requiring Endotracheal Intubation
Time frame: 7 days
Infants will have an endotracheal placed if their inspired oxygen is >45% for more than 15 minutes
2 secondary outcomes
Duration of positive pressure support
Time frame: 36 weeks corrected gestational age
Duration of Supplemental oxygen
Time frame: 36 weeks corrected gestational age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Background: PubMed 20084586Kribs 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 publication: PubMed 34902013Dargaville 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MIST surfactant in people with Respiratory Distress Syndrome, run by Endeavor Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew Derrick (18475702920, mderrick@northshore.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of infants requiring Endotracheal Intubation (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06074380, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.