Respiratory Distress Syndrome in Premature InfantREMEDIESNCT05791331
REspiratory MEchanics for Delivering Individualised Exogenous Surfactant
A study testing Surfactant administration following lung mechanics assessment in addition to clinical assessment and Surfactant administration following clinical assessment in people with Respiratory Distress Syndrome in Premature Infant, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
This study is an interventional, non-pharmacological, multicentric, randomized, controlled, superiority, non-profit study. Its primary objective is to evaluate if the administration of surfactant based on FOT assessment will allow a 5-day reduction in the duration of respiratory support as compared to standard… Read more about this study
- Who is it for?
- Ages 27 to 33 weeks
- Conditions the study is for
- Respiratory Distress Syndrome in Premature Infant
- What is being tested?
- Surfactant administration following lung mechanics assessment in addition to clinical assessment and Surfactant administration following clinical assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 458 participants
- Where
- 1 siteItaly
- Study dates
- 15 Dec 2023to 31 Dec 2028
- Phase
- Interventional
- 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 27 to 33 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age (GA) ≥ 27+0 and < 33+0 weeks
- Spontaneously breathing infants, requiring non-invasive respiratory support (nasal CPAP or bilevel nasal CPAP). Criteria for commencement of non-invasive respiratory support: FiO2 >0.30 for target SpO2 88-93% or Silverman score ≥ 5.
- Inborn
- Written parental consent obtained
- Administration of Caffeine bolus 20 mg/kg IV or PO as per standard care
Who cannot join
- Major congenital anomalies
- Need of intubation in delivery suite according to the AAP guidelines for neonatal resuscitation or early at the admission in NICU (within one hour from birth).
- Surfactant therapy prior to the study entry
- Severe birth asphyxia, defined by APGAR score ≤ 5 at 10 minutes after birth OR continued need for resuscitation 10 minutes after birth OR pH < 7.0 or base excess (BE) < -12 mmol/l on umbilical cord or on an arterial or capillary blood sample obtained within 1 hour from birth OR moderate to severe encephalopathy
- Respiratory failure secondary to conditions other that RDS as identified by lung imaging (air leaks, lung malformations…)
- Any clinical condition which may place the infants at undue risk as deemed by clinicians
- Participation to trials with competitive outcomes or likely to have an impact on the primary outcome of the study
- Outborn patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCs Cà Granda Ospedale Maggiore Policlinico
Milan
Anna Lavizzari, MD, 0039 3208715095, anna.lavizzari@gmail.com
About this study
Official title: A Randomized Controlled Trial of Oscillatory Mechanics Versus Oxygenation-based Criteria for Surfactant Therapy
This study is an interventional, non-pharmacological, multicentric, randomized, controlled, superiority, non-profit study. Its primary objective is to evaluate if the administration of surfactant based on FOT assessment will allow a 5-day reduction in the duration of respiratory support as compared to standard practice in preterm infants between 27+0 and 32+6 weeks' gestation. The secondary objectives are:
- to determine if a lung mechanics-based approach for administering surfactant will change treatment timing; and
- to assess the impact of the novel approach on other neonatal general outcomes. The study will take place within the neonatal intensive care units. Non-invasive respiratory support will be delivered by nasal CPAP with a starting pressure of 5-8 cmH2O. FiO2 will be titrated in order to achieve the target SpO2 91-95%.
Read more
Infants matching the clinical criteria for inclusion will be randomized in two arms following the current data protection and confidentiality regulations. Central, computer-generated randomization (allocation 1:1) with variable block sizes according to gestational age will be used. Infants will be stratified according to gestational age (27+0 -28+6 weeks; 29+0 -30+6 weeks; 31+0 -32+6 weeks) and center.
Study Arms:
- Surfactant administration following oxygenation-based criteria (clinical assessment) (control) B) Surfactant administration following both lung mechanics assessment OR oxygenation-based criteria (clinical assessment) (intervention).
- Being tested
- Surfactant administration following lung mechanics assessment in addition to clinical assessment, Surfactant administration following clinical assessment
- Keywords
- Surfactant, Respiratory mechanics, Respiratory Oscillometry, Forced Oscillation technique, Neonatal RDS, CPAP, CPAP failure, Premature infant
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surfactant administration following lung mechanics assessment in addition to clinical assessmentOther
Surfactant is administered following oxygenation-based criteria and if the Xrs is ≤ -23.3 cmH2O*s /L
Surfactant administration following clinical assessmentOther
Surfactant is administered following oxygenation-based criteria
| Study group | Role | What they receive |
|---|---|---|
| A/Control | Active comparator | Surfactant administration following clinical assessment Receives: Other: Surfactant administration following clinical assessment |
| B/Intervention | Experimental | Surfactant administration following both lung mechanics assessment and clinical assessment Receives: Other: Surfactant administration following lung mechanics assessment in addition to clinical assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days of respiratory support
Number of days of required respiratory support
Measured: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
Secondary outcomes (15)
First surfactant administration
Time of first surfactant administration (in hours)
Measured: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
Days of non-invasive respiratory support
Number of days of non-invasive respiratory support
Measured: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
Days of invasive respiratory support
Number of days of invasive respiratory support
Measured: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
Patients intubated and mechanically ventilated
Number of patients intubated and mechanically ventilated
Measured: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
Patients receiving multiple surfactant doses
Number of patients receiving multiple surfactant doses
Measured: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
Days on supplemental oxygen
Number of days on supplemental oxygen
Measured: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
Total cumulative oxygen exposure
Total cumulative oxygen exposure computed as the time integral of the FiO2 values
Measured: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
Infants receiving more than 28 days of respiratory support
Number of infants receiving more than 28 days of respiratory support
Measured: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
Infants developing BPD
Number of infants developing BPD according to the definition by NICHD 2016
Measured: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
Infants developing air-leaks
Number of infants developing air-leaks
Measured: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
Infants developing prematurity-associated complications
Number of infants developing prematurity-associated complications (severe intraventricular haemorrhage (IVH), periventricular leukomalacia (PVL), necrotizing enterocolitis (NEC), sepsis, retinopathy of prematurity (ROP), patent ductus arteriosus requiring pharmacological or surgical treatment)
Measured: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
Infants discharged home with oxygen or respiratory support
Number of infants discharged home with oxygen or respiratory support
Measured: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
Days to achieve full-enteral feeding
Number of days to achieve full-enteral feeding (160 ml/kg/day of milk intake)
Measured: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
Days of hospitalization
Number of days of hospitalization
Measured: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
Infants receiving postnatal steroids
Number of infants receiving postnatal steroids
Measured: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start15 Dec 2023
- Primary completion30 May 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome in Premature InfantStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 458 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Politecnico di Milano
- Responsible party
- Principal investigator, Anna Lavizzari, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05791331
- Sponsor's protocol ID
- Sperimentazione 3115
- Other IDs
- Studio Numero 6379
- Acronym
- REMEDIES
- Status last verified
- Nov 2026
- First submitted
- 9 Dec 2022
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Oscillatory Mechanics Versus Oxygenation-based Criteria for Surfactant Therapy
- ClinicalTrials.gov ID
- NCT05791331
- Acronym / sponsor ID
- REMEDIES / Sperimentazione 3115
- Keywords
- Surfactant, Respiratory mechanics, Respiratory Oscillometry, Forced Oscillation technique, Neonatal RDS, CPAP, CPAP failure, Premature infant
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 458 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Collaborators
- Politecnico di Milano
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 30 May 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 30 Mar 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.
This study is an interventional, non-pharmacological, multicentric, randomized, controlled, superiority, non-profit study. Its primary objective is to evaluate if the administration of surfactant based on FOT assessment will allow a 5-day reduction in the duration of respiratory support as compared to standard practice in preterm infants between 27+0 and 32+6 weeks' gestation. The secondary objectives are:
- to determine if a lung mechanics-based approach for administering surfactant will change treatment timing; and
- to assess the impact of the novel approach on other neonatal general outcomes. The study will take place within the neonatal intensive care units. Non-invasive respiratory support will be delivered by nasal CPAP with a starting pressure of 5-8 cmH2O. FiO2 will be titrated in order to achieve the target SpO2 91-95%.
Infants matching the clinical criteria for inclusion will be randomized in two arms following the current data protection and confidentiality regulations. Central, computer-generated randomization (allocation 1:1) with variable block sizes according to gestational age will be used. Infants will be stratified according to gestational age (27+0 -28+6 weeks; 29+0 -30+6 weeks; 31+0 -32+6 weeks) and center.
Study Arms:
- Surfactant administration following oxygenation-based criteria (clinical assessment) (control) B) Surfactant administration following both lung mechanics assessment OR oxygenation-based criteria (clinical assessment) (intervention).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| A/Control | Active comparator | Other: Surfactant administration following clinical assessmentSurfactant administration following clinical assessment |
| B/Intervention | Experimental | Other: Surfactant administration following lung mechanics assessment in addition to clinical assessmentSurfactant administration following both lung mechanics assessment and clinical assessment |
Who may qualify
- Ages
- 27 to 33 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Gestational age (GA) ≥ 27+0 and < 33+0 weeks
- Spontaneously breathing infants, requiring non-invasive respiratory support (nasal CPAP or bilevel nasal CPAP). Criteria for commencement of non-invasive respiratory support: FiO2 >0.30 for target SpO2 88-93% or Silverman score ≥ 5.
- Inborn
- Written parental consent obtained
- Administration of Caffeine bolus 20 mg/kg IV or PO as per standard care
Key exclusion criteria (8 listed)
- Major congenital anomalies
- Need of intubation in delivery suite according to the AAP guidelines for neonatal resuscitation or early at the admission in NICU (within one hour from birth).
- Surfactant therapy prior to the study entry
- Severe birth asphyxia, defined by APGAR score ≤ 5 at 10 minutes after birth OR continued need for resuscitation 10 minutes after birth OR pH < 7.0 or base excess (BE) < -12 mmol/l on umbilical cord or on an arterial or capillary blood sample obtained within 1 hour from birth OR moderate to severe encephalopathy
- Respiratory failure secondary to conditions other that RDS as identified by lung imaging (air leaks, lung malformations…)
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 |
|---|---|---|
| Surfactant administration following lung mechanics assessment in addition to clinical assessmentSurfactant is administered following oxygenation-based criteria and if the Xrs is ≤ -23.3 cmH2O*s /L | Other | B/Intervention |
| Surfactant administration following clinical assessmentSurfactant is administered following oxygenation-based criteria | Other | A/Control |
Primary outcome
Days of respiratory support
Time frame: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
Number of days of required respiratory support
15 secondary outcomes
First surfactant administration
Time frame: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
Days of non-invasive respiratory support
Time frame: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
Days of invasive respiratory support
Time frame: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
Patients intubated and mechanically ventilated
Time frame: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
Patients receiving multiple surfactant doses
Time frame: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
Days on supplemental oxygen
Time frame: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
Total cumulative oxygen exposure
Time frame: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
Infants receiving more than 28 days of respiratory support
Time frame: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
Infants developing BPD
Time frame: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
Infants developing air-leaks
Time frame: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
Infants developing prematurity-associated complications
Time frame: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
Infants discharged home with oxygen or respiratory support
Time frame: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
Days to achieve full-enteral feeding
Time frame: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
Days of hospitalization
Time frame: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
Infants receiving postnatal steroids
Time frame: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
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 5 Nov 2026.
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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 study testing Surfactant administration following lung mechanics assessment in addition to clinical assessment and Surfactant administration following clinical assessment in people with Respiratory Distress Syndrome in Premature Infant, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
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 5 inclusion and 8 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 5 Nov 2026. 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 Italy. 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.
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 Anna Lavizzari, MD (0039 3208715095, anna.lavizzari@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days of respiratory support (time frame: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2026.