Infant, Premature, DiseasesNEU-CAPNCT07754032
The NEU - CAP Trial
A study testing CO₂-guided Non-Invasive Ventilation in people with Infant, Premature, Diseases and Birth, Preterm, run by Leiden University Medical Center.
Trial summary
The aim of NEU-CAP is to investigate the clinical impact of using a colorimetric carbon dioxide (CO₂) detector during non-invasive ventilation (NIV). Infants born before 32 weeks of gestation will be included in this trial. This is a stepped-wedge cluster randomised controlled trial. Read more about this study
- Who is it for?
- Ages Up to 32 weeks
- Conditions the study is for
- Infant, Premature, Diseases, Birth, Preterm, Respiratory Distress Neonatal
- What is being tested?
- CO₂-guided Non-Invasive Ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,860 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Mar 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 Up to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Born before 32 weeks of gestation
- Received non-humidified face-mask support in the first 10 minutes of life
- Parental consent obtained
Who cannot join
- Congenital diaphragmatic hernia
- Tracheo-oesophageal fistula
- Cyanotic heart disease
- Surfactant protein deficiency
- Any other congenital abnormality or condition with an adverse effect on breathing, ventilation, or oxygenation. Many of the infants enrolled in the study will later be diagnosed with respiratory distress syndrome (RDS); this will not render them ineligible for inclusion.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomised Trial of Colorimetric Carbon Dioxide (CO₂) Detector-guided Non-invasive Ventilation Versus Standard Care: The NEU-CAP Trial
The aim of NEU-CAP is to investigate the clinical impact of using a colorimetric carbon dioxide (CO₂) detector during non-invasive ventilation (NIV). Infants born before 32 weeks of gestation will be included in this trial. This is a stepped-wedge cluster randomised controlled trial. The participating centre, rather than the individual infant, will be the unit of randomisation. This design is appropriate to test the effect of an intervention that encompasses a behavioural aspect, in this case CO₂-detector-guided non-invasive ventilation.
Read the detailed description
Rationale: Most infants establish effective gas exchange after birth independently with spontaneous breathing. Those that don't, receive breathing support non-invasively either through a face mask or invasively through endotracheal tube (ETT). Endotracheal ventilation is associated with lung injury in preterm infants. As a result, clinicians aim to support premature infants non-invasively and to only intubate those who don't respond adequately to mask positive pressure ventilation (PPV). It is a challenge for clinicians to judge how well infants are breathing and the effect of PPV during face mask breathing support. Current methods of monitoring provide indirect feedback that may be difficult to interpret. Exhaled carbon dioxide (CO₂) detectors that change colour in the presence of CO₂ are used to confirm ETT position. Detection of CO₂ during mask breathing support may offer a direct indication of gas exchange, which might allow for better assessment of spontaneous breathing and ventilation effectiveness.
Objective: To assess the effect of colorimetric CO₂ detector use during non-invasive ventilation, versus standard care, on the proportion of neonates receiving PPV after 5 minutes of life
Study design: This is a stepped-wedge cluster randomised trial, with randomisation occurring at the level of the participating hospital rather than the individual infant. This design is suitable for evaluating interventions with a potential learning effect and supports a structured implementation across study sites.
Study population: Infants receiving non-invasive breathing support in the first 10 minutes of life, born before 32 weeks of gestation.
Intervention: At the start of the study, all participating centres will continue their standard practice by providing non-invasive breathing support without using a CO₂ detector. As the study progresses, centres will switch one-by-one to using the colorimetric CO₂ detector during mask breathing support until all have switched. Once they have switched, centres will continue to use the CO₂ detector until the end of the study.
Main study parameter: The proportion of infants receiving PPV after 5 minutes of life.
- Being tested
- Local standard care of monitoring non-invasive ventilation, CO₂-guided Non-Invasive Ventilation
- Keywords
- Resuscitation, Preterm infant, Non-invasive ventilation, CO₂-detection
- Medical subject headings
- Infant, Premature, Diseases, Premature Birth, Hyaline Membrane Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local standard care of monitoring non-invasive ventilationProcedure or surgery
See arm
CO₂-guided Non-Invasive VentilationProcedure or surgery
See arm
| Study group | Role | What they receive |
|---|---|---|
| Standard care | Active comparator | At the start of the study, all participating centres will provide NIV using the standard monitoring methods in place as part of their local standard of care; this will not include using a CO₂ detector at any centre. No additional tools or changes to monitoring protocols will be introduced during this period. Receives: Procedure: Local standard care of monitoring non-invasive ventilation |
| Colorimetric CO₂-detector-guided non-invasive ventilation | Experimental | For each centre, a lot will be drawn which indicates the fortnight in which the protocol changes from standard care to CO₂-detector-guided non-invasive ventilation.
Colorimetric CO₂ detectors have a chemical indicator that changes colour when a threshold level of CO₂ is exceeded. They are routinely used in newborn infants to confirm that an endotracheal tube (ETT) is correctly placed in the trachea. The CO₂ detector also has promise as a tool to directly assess lung aeration during mask breathing support. It could offer immediate feedback on both the adequacy of spontaneous breathing during continuous positive airway pressure (CPAP) and the effectiveness of PPV in non-breathing neonates. The colorimetric CO₂ detector used in this study has been developed specifically for use during NIV.
All other procedures in the delivery room and neonatal intensive care unit (NICU) will be performed according to international and local guidelines. Receives: Procedure: CO₂-guided Non-Invasive Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of positive pressure ventilation (PPV) between 5 and 10 minutes after birth
Proportion of infants receiving positive pressure ventilation between 5 and 10 minutes after birth
Measured: 5-10 minutes after birth
Secondary outcomes (18)
Use of PPV before 1 minute
Proportion of infants receiving positive pressure ventilation before 1 minute after birth
Measured: Before 1 minute after birth
Use of PPV between 1 and 5 minutes
Proportion of infants receiving Positive Pressure Ventilation between 1 and 5 minutes after birth
Measured: 1-5 minutes after birth
Use of PPV after 10 minutes
Proportion of infants who continued to receive positive pressure ventilation in the delivery room after 10 minutes after birth
Measured: After 10 minutes after birth
Heart rate
Heart rate
Measured: At 5 minutes after birth
Apgar score
Apgar score at 1, 5 and 10 minutes after birth. Scores range from 0 to 10, with higher scores indicating a better clinical condition.
Measured: 1, 5 and 10 minutes after birth
Use of PPV <10 min
Proportion of infants receiving positive pressure ventilation within the first 10 minutes after birth
Measured: Within 10 minutes after birth
Number of infants who received chest compressions <10min
Number of infants who received chest compressions
Measured: Within 10 minutes after birth
Number of infants who were intubated <10min
Number of infants who were endotracheally intubated
Measured: Within 10 minutes after birth
Number of infants who were administered adrenaline <10min
Number of infants who were administered adrenaline
Measured: Within 10 minutes after birth
Number of infants who were administered volume expansion <10min
Number of infants who were administered volume expansion
Measured: Within 10 minutes after birth
Death <10min
Number of infants who died in the first 10 minutes after birth
Measured: Within 10 minutes after birth
Number of infants who were supported by continuous positive airway pressure (CPAP) in the first week after birth
CPAP use in the neonatal intensive care unit (NICU)
Measured: In the first week after birth
Number of infants who received surfactant in first week
Surfactant administration via
- Intubate-Surfactant-Extubate (INSURE)
- Less Invasive Surfactant Administration (LISA)
- ET tube
Measured: In the first week after birth
Surfactant doses
Number of surfactant doses administered
Measured: In the first week after birth
Number of infants who were mechanically ventilated
Mechanical ventilation
Measured: In the first week after birth
Number of infants with abnormalities on the first cranial ultrasound
Abnormalities on first cranial ultrasound: Intraventricular haemorrhage (IVH)/periventricular leukomalacia (PVL)
Measured: In the first week after birth
Number of infants who died in the first week after birth
Mortality
Measured: In the first week after birth
Cord clamping time
The time after birth at which the cord is clamped
Measured: During resuscitation at birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study startJan 2027 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, Premature, DiseasesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Stepped-Wedge Cluster Randomised Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,860 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Janneke Dekker, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07754032
- Sponsor's protocol ID
- 25-3116
- Acronym
- NEU-CAP
- Status last verified
- Aug 2026
- First submitted
- 30 Jul 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Trial of Colorimetric Carbon Dioxide (CO₂) Detector-guided Non-invasive Ventilation Versus Standard Care: The NEU-CAP Trial
- ClinicalTrials.gov ID
- NCT07754032
- Acronym / sponsor ID
- NEU-CAP / 25-3116
- Keywords
- Resuscitation, Preterm infant, Non-invasive ventilation, CO₂-detection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,860 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 10 Aug 2026 (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.
The aim of NEU-CAP is to investigate the clinical impact of using a colorimetric carbon dioxide (CO₂) detector during non-invasive ventilation (NIV). Infants born before 32 weeks of gestation will be included in this trial. This is a stepped-wedge cluster randomised controlled trial. The participating centre, rather than the individual infant, will be the unit of randomisation. This design is appropriate to test the effect of an intervention that encompasses a behavioural aspect, in this case CO₂-detector-guided non-invasive ventilation.
Detailed description
Rationale: Most infants establish effective gas exchange after birth independently with spontaneous breathing. Those that don't, receive breathing support non-invasively either through a face mask or invasively through endotracheal tube (ETT). Endotracheal ventilation is associated with lung injury in preterm infants. As a result, clinicians aim to support premature infants non-invasively and to only intubate those who don't respond adequately to mask positive pressure ventilation (PPV). It is a challenge for clinicians to judge how well infants are breathing and the effect of PPV during face mask breathing support. Current methods of monitoring provide indirect feedback that may be difficult to interpret. Exhaled carbon dioxide (CO₂) detectors that change colour in the presence of CO₂ are used to confirm ETT position. Detection of CO₂ during mask breathing support may offer a direct indication of gas exchange, which might allow for better assessment of spontaneous breathing and ventilation effectiveness.
Objective: To assess the effect of colorimetric CO₂ detector use during non-invasive ventilation, versus standard care, on the proportion of neonates receiving PPV after 5 minutes of life
Study design: This is a stepped-wedge cluster randomised trial, with randomisation occurring at the level of the participating hospital rather than the individual infant. This design is suitable for evaluating interventions with a potential learning effect and supports a structured implementation across study sites.
Study population: Infants receiving non-invasive breathing support in the first 10 minutes of life, born before 32 weeks of gestation.
Intervention: At the start of the study, all participating centres will continue their standard practice by providing non-invasive breathing support without using a CO₂ detector. As the study progresses, centres will switch one-by-one to using the colorimetric CO₂ detector during mask breathing support until all have switched. Once they have switched, centres will continue to use the CO₂ detector until the end of the study.
Main study parameter: The proportion of infants receiving PPV after 5 minutes of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Stepped-Wedge Cluster Randomised Trial
| Arm | Type | Receives |
|---|---|---|
| Standard care | Active comparator | Procedure: Local standard care of monitoring non-invasive ventilationAt the start of the study, all participating centres will provide NIV using the standard monitoring methods in place as part of their local standard of care; this will not include using a CO₂ detector at any centre. No additional tools or changes to monitoring protocols will be introduced during this period. |
| Colorimetric CO₂-detector-guided non-invasive ventilation | Experimental | Procedure: CO₂-guided Non-Invasive VentilationFor each centre, a lot will be drawn which indicates the fortnight in which the protocol changes from standard care to CO₂-detector-guided non-invasive ventilation. Colorimetric CO₂ detectors have a chemical indicator that changes colour when a threshold level of CO₂ is exceeded. They are routinely used in newborn infants to confirm that an endotracheal tube (ETT) is correctly placed in the trachea. The CO₂ detector also has promise as a tool to directly assess lung aeration during mask breathing support. It could offer immediate feedback on both the adequacy of spontaneous breathing during continuous positive airway pressure (CPAP) and the effectiveness of PPV in non-breathing neonates. The colorimetric CO₂ detector used in this study has been developed specifically for use during NIV. All other procedures in the delivery room and neonatal intensive care unit (NICU) will be performed according to international and local guidelines. |
Who may qualify
- Ages
- Up to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Born before 32 weeks of gestation
- Received non-humidified face-mask support in the first 10 minutes of life
- Parental consent obtained
Key exclusion criteria (5 listed)
- Congenital diaphragmatic hernia
- Tracheo-oesophageal fistula
- Cyanotic heart disease
- Surfactant protein deficiency
- Any other congenital abnormality or condition with an adverse effect on breathing, ventilation, or oxygenation. Many of the infants enrolled in the study will later be diagnosed with respiratory distress syndrome (RDS); this will not render them ineligible for inclusion.
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 |
|---|---|---|
| Local standard care of monitoring non-invasive ventilationSee arm | Procedure or surgery | Standard care |
| CO₂-guided Non-Invasive VentilationSee arm | Procedure or surgery | Colorimetric CO₂-detector-guided non-invasive ventilation |
Primary outcome
Use of positive pressure ventilation (PPV) between 5 and 10 minutes after birth
Time frame: 5-10 minutes after birth
Proportion of infants receiving positive pressure ventilation between 5 and 10 minutes after birth
18 secondary outcomes
Use of PPV before 1 minute
Time frame: Before 1 minute after birth
Use of PPV between 1 and 5 minutes
Time frame: 1-5 minutes after birth
Use of PPV after 10 minutes
Time frame: After 10 minutes after birth
Heart rate
Time frame: At 5 minutes after birth
Apgar score
Time frame: 1, 5 and 10 minutes after birth
Use of PPV <10 min
Time frame: Within 10 minutes after birth
Number of infants who received chest compressions <10min
Time frame: Within 10 minutes after birth
Number of infants who were intubated <10min
Time frame: Within 10 minutes after birth
Number of infants who were administered adrenaline <10min
Time frame: Within 10 minutes after birth
Number of infants who were administered volume expansion <10min
Time frame: Within 10 minutes after birth
Death <10min
Time frame: Within 10 minutes after birth
Number of infants who were supported by continuous positive airway pressure (CPAP) in the first week after birth
Time frame: In the first week after birth
Number of infants who received surfactant in first week
Time frame: In the first week after birth
Surfactant doses
Time frame: In the first week after birth
Number of infants who were mechanically ventilated
Time frame: In the first week after birth
Number of infants with abnormalities on the first cranial ultrasound
Time frame: In the first week after birth
Number of infants who died in the first week after birth
Time frame: In the first week after birth
Cord clamping time
Time frame: During resuscitation at birth
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 10 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing CO₂-guided Non-Invasive Ventilation in people with Infant, Premature, Diseases and Birth, Preterm, run by Leiden University Medical Center.
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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Mirthe M Bloemhof, MD (+31715298760, m.m.bloemhof@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of positive pressure ventilation (PPV) between 5 and 10 minutes after birth (time frame: 5-10 minutes after birth). 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 10 Aug 2026.