An interventional study of Local standard care of monitoring non-invasive ventilation and CO₂-guided Non-Invasive Ventilation in Infant, Premature, Diseases, Birth, Preterm and Respiratory Distress Neonatal, sponsored by Leiden University Medical Center. Not yet recruiting. Open to participants aged Up to 32 Weeks. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by Leiden University Medical Center · Not applicable, Interventional, and Treatment
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.
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.
88 studies on the registry are indexed under Infant, Premature, Diseases; 12 are open to participants now.
This study's planned enrollment of 1,860 is above the median of 63 across 57 interventional studies indexed under Infant, Premature, Diseases.
Browse Infant, Premature, Diseases studies →Leiden University Medical Center is the lead sponsor of 334 studies on the registry; 110 are open to participants now.
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Exclusion Criteria:
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.
Procedure: Local standard care of monitoring non-invasive ventilation
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.
Procedure: CO₂-guided Non-Invasive Ventilation
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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
Time frame: 5-10 minutes after birth
Use of PPV before 1 minute
Proportion of infants receiving positive pressure ventilation before 1 minute after birth
Time frame: 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
Time frame: 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
Time frame: After 10 minutes after birth
Heart rate
Heart rate
Time frame: 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.
Time frame: 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
Time frame: Within 10 minutes after birth
Number of infants who received chest compressions <10min
Number of infants who received chest compressions
Time frame: Within 10 minutes after birth
Number of infants who were intubated <10min
Number of infants who were endotracheally intubated
Time frame: Within 10 minutes after birth
Number of infants who were administered adrenaline <10min
Number of infants who were administered adrenaline
Time frame: Within 10 minutes after birth
Number of infants who were administered volume expansion <10min
Number of infants who were administered volume expansion
Time frame: Within 10 minutes after birth
Death <10min
Number of infants who died in the first 10 minutes after birth
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
CPAP use in the neonatal intensive care unit (NICU)
Time frame: 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
Time frame: In the first week after birth
Surfactant doses
Number of surfactant doses administered
Time frame: In the first week after birth
Number of infants who were mechanically ventilated
Mechanical ventilation
Time frame: 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)
Time frame: In the first week after birth
Number of infants who died in the first week after birth
Mortality
Time frame: In the first week after birth
Cord clamping time
The time after birth at which the cord is clamped
Time frame: During resuscitation at birth
Number of infants diagnosed with congenital anomalies
Whether the infant has congenital anomalies, e.g. diaphragmatic hernia, oesophageal atresia, cyanotic heart disease
Time frame: At birth
Gestational age
Gestational age at birth in weeks and days
Time frame: At birth
Gender
Gender of the infant
Time frame: At birth
Mode of delivery
Mode of delivery
Time frame: At birth
Doses of antenatal steroids
Number of doses of antenatal steroids administered
Time frame: Before birth
Number of Infants Whose Mothers Received General Anaesthesia
Maternal general anaesthesia
Time frame: Before birth
Complications during pregnancy
Whether there were any complications during pregnancy, e.g. premature prolonged rupture of membranes, chorioamnionitis, pre-eclampsia, placental abruption, twin-to-twin transfusion syndrome, hydrops fetalis, feto-maternal haemorrhage
Time frame: Before birth
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Mar 2028, 14 months later.
Of 33 non-industry interventional studies with no phase under Infant, Premature, Diseases, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 29. This study's planned 14 months is below that.
Counting every sponsor, half of 33 studies reached it within 19 months; a quarter within 11 and three quarters within 29.
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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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