The NEU - CAP Trial
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 32
SponsorLeiden University Medical Center
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Born before 32 weeks of gestation
Received non-humidified face-mask support in the first 10 minutes of life
Parental consent obtained
Disqualifiers
Congenital diaphragmatic hernia
Tracheo-oesophageal fistula
Cyanotic heart disease
Surfactant protein deficiency
Trial design
Design model
Parallel
Treatments tested in this trial
Local standard care of monitoring non-invasive ventilation
Procedure/SurgerySee arm
CO₂-guided Non-Invasive Ventilation
Procedure/SurgerySee arm
Treatment groups
1,860 Participants
are divided into 2 treatment groupsGroup A: Standard careActive comparator 1 intervention
Group B: Colorimetric CO₂-detector-guided non-invasive ventilationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 birthSecondary outcomes
1
Use of PPV before 1 minute
Proportion of infants receiving positive pressure ventilation before 1 minute after birth
Time frame
Before 1 minute after birth2
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 birth3
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 birth4
Heart rate
Heart rate
Time frame
At 5 minutes after birthOther outcomes
1
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 birth2
Gestational age
Gestational age at birth in weeks and days
Time frame
At birth3
Gender
Gender of the infant
Time frame
At birth4
Mode of delivery
Mode of delivery
Time frame
At birthLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: