About this trial
Preterm neonates born at less than 30 weeks' gestation are commonly maintained on invasive or non-invasive respiratory support to facilitate gas exchange. While non-invasive respiratory support (NIS) can be gradually reduced over time as the infant grows, most weaning strategies often lead to weaning failure. This failure is evidenced by an increase in significant events such as apneas, desaturations, and/or bradycardias, increased work of breathing, or an inability to oxygenate or ventilate, resulting in escalated respiratory support. Although the optimal approach to weaning NIS remains uncertain, neonatal units that delay Continuous Positive Airway Pressure (CPAP) weaning until 32-34 weeks corrected gestational age exhibit lower rates of chronic lung disease. Therefore, the investigators aim to compare the duration on respiratory support and oxygen exposure in infants born at less than 30 weeks' gestational age who undergo a structured weaning protocol that includes remaining on CPAP until at least 32-34 weeks corrected gestational age (CGA). The hypothesis posits that preterm infants following a structured weaning protocol, including maintaining CPAP until a specific gestational age, will demonstrate lower rates of weaning failure off CPAP (defined as requiring more support and/or experiencing increased stimulation events 72 hours after CPAP weaning) than those managed according to the medical team's discretion.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All infants admitted to the NICU at Jacobs, Rancho Springs, Scripps La Jolla, Rady Children's Hospital, or Palomar born at < 30 weeks CGA
Informed parental consent obtained
Disqualifiers
Declined or unable to give informed consent
Infants with known congenital anomalies or complications that require long term support (pulmonary hypoplasia, airway defects, genetic syndromes, necrotizing enterocolitis (NEC), spontaneous intestinal perforation (SIP), anything surgical)
Intubated for over 4 weeks of life (28 days)
Trial design
Parallel
Treatments tested in this trial
Standardized/structured CPAP weaning protocol
Other interventionStandardized/structured CPAP weaning protocol up to 32 or 34 weeks gestational age (GA) (based on GA at birth) for infants born at less than 30 weeks GA.
Treatment groups
Trial outcomes
Primary outcomes
Number of participants with CPAP/NIS weaning failure
Number of participants needing more support and/or with increased sleep stimulation events after weaning off of CPAP/NIS.
Secondary outcomes
Number of stimulation events per 24 hours
Significant results are defined as: apnea (pause in respiration for greater than 20 seconds), and/or bradycardia (heart rate \< 100) and/or desaturations (pulse oximetry saturations \< 85%) not associated with feeds.
Length of hospital stay
Length of hospital stay prior to discharge home, including days at transfer hospital (if applicable).
Rate of bronchopulmonary dysplasia
Bronchopulmonary dysplasia (BPD) assessed at 36 weeks gestational age.
Use of postnatal steroids
Use of postnatal steroids during the NICU course
Sponsors and contacts
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University of California, San Diego
Lead sponsor
Rady Children's Hospital, San Diego
Collaborator