Birth, Preterm, Infant, Premature, Diseases, Respiratory Distress Neonatal
Conditions
Keywords
Resuscitation, Preterm infant, Non-invasive ventilation, CO₂-detection
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.
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.
Interventions
PROCEDURELocal standard care of monitoring non-invasive ventilation
See arm
PROCEDURECO₂-guided Non-Invasive Ventilation
See arm
Sponsors
Leiden University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
Stepped-Wedge Cluster Randomised Trial
Eligibility
Sex/Gender
ALL
Age
No minimum to 32 Weeks
Healthy volunteers
No
Inclusion criteria
* Born before 32 weeks of gestation * Received non-humidified face-mask support in the first 10 minutes of life * Parental consent obtained
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Use of positive pressure ventilation (PPV) between 5 and 10 minutes after birth | 5-10 minutes after birth | Proportion of infants receiving positive pressure ventilation between 5 and 10 minutes after birth |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Use of PPV before 1 minute | Before 1 minute after birth | Proportion of infants receiving positive pressure ventilation before 1 minute after birth |
| Use of PPV between 1 and 5 minutes | 1-5 minutes after birth | Proportion of infants receiving Positive Pressure Ventilation between 1 and 5 minutes after birth |
| Use of PPV after 10 minutes | After 10 minutes after birth | Proportion of infants who continued to receive positive pressure ventilation in the delivery room after 10 minutes after birth |
| Heart rate | At 5 minutes after birth | Heart rate |
| Apgar score | 1, 5 and 10 minutes after birth | Apgar score at 1, 5 and 10 minutes after birth. Scores range from 0 to 10, with higher scores indicating a better clinical condition. |
| Use of PPV <10 min | Within 10 minutes after birth | Proportion of infants receiving positive pressure ventilation within the first 10 minutes after birth |
| Number of infants who received chest compressions <10min | Within 10 minutes after birth | Number of infants who received chest compressions |
| Number of infants who were intubated <10min | Within 10 minutes after birth | Number of infants who were endotracheally intubated |
| Number of infants who were administered adrenaline <10min | Within 10 minutes after birth | Number of infants who were administered adrenaline |
| Number of infants who were administered volume expansion <10min | Within 10 minutes after birth | Number of infants who were administered volume expansion |
| Death <10min | Within 10 minutes after birth | Number of infants who died in the first 10 minutes after birth |
| Number of infants who were supported by continuous positive airway pressure (CPAP) in the first week after birth | In the first week after birth | CPAP use in the neonatal intensive care unit (NICU) |
| Number of infants who received surfactant in first week | In the first week after birth | Surfactant administration via * Intubate-Surfactant-Extubate (INSURE) * Less Invasive Surfactant Administration (LISA) * ET tube |
| Surfactant doses | In the first week after birth | Number of surfactant doses administered |
| Number of infants who were mechanically ventilated | In the first week after birth | Mechanical ventilation |
| Number of infants with abnormalities on the first cranial ultrasound | In the first week after birth | Abnormalities on first cranial ultrasound: Intraventricular haemorrhage (IVH)/periventricular leukomalacia (PVL) |
| Number of infants who died in the first week after birth | In the first week after birth | Mortality |
| Cord clamping time | During resuscitation at birth | The time after birth at which the cord is clamped |
Contacts
CONTACTMirthe M Bloemhof, MD
CONTACTJanneke Dekker, PhD
Outcome results
None listed