The NEU - CAP Trial

NCT07754032 | Not Yet Recruiting

• 1 other identifier: 25-3116
• Study Type: interventional
• Target: 1,860
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Infant, Premature, Diseases; Birth, Preterm; Respiratory Distress Neonatal

Keywords

Resuscitation; Preterm infant; Non-invasive ventilation; CO₂-detection

Outcome Measures

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

  5-10 minutes after birth

Secondary Outcomes (18)

• Use of PPV before 1 minute

  Before 1 minute after birth

• Use of PPV between 1 and 5 minutes

  1-5 minutes after birth

• Use of PPV after 10 minutes

  After 10 minutes after birth

• Heart rate

  At 5 minutes after birth

• Apgar score

  1, 5 and 10 minutes after birth

Other Outcomes (7)

• Number of infants diagnosed with congenital anomalies

  At birth

• Gestational age

  At birth

• Gender

  At birth

Study Arms (2)

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.

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.

Procedure: CO₂-guided Non-Invasive Ventilation

Interventions

Local standard care of monitoring non-invasive ventilation PROCEDURE

See arm

Standard care

CO₂-guided Non-Invasive Ventilation PROCEDURE

See arm

Colorimetric CO₂-detector-guided non-invasive ventilation

Eligibility Criteria

• Age: Up to 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Born before 32 weeks of gestation
• Received non-humidified face-mask support in the first 10 minutes of life
• Parental consent obtained

You may not qualify if:

• Congenital diaphragmatic hernia
• Tracheo-oesophageal fistula
• Cyanotic heart disease
• Surfactant protein deficiency

Sponsors & Collaborators

• Leiden University Medical Center: lead

MeSH Terms

Conditions

Infant, Premature, Diseases; Premature Birth; Hyaline Membrane Disease

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Respiratory Distress Syndrome, Newborn; Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Central Study Contacts

Mirthe M Bloemhof, MD

CONTACT

+31715298760; m.m.bloemhof@lumc.nl

Janneke Dekker, PhD

CONTACT

+31715266620; j.dekker@lumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Centres will be randomised for the fortnight at which they will switch their non-invasive ventilation practice from standard care to CO₂-detector-guided non-invasive ventilation. The analysing researcher will be blinded for the allocation of treatment switch.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Stepped-Wedge Cluster Randomised Trial

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 10, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: August 10, 2026

Record last verified: 2026-08