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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.
Full description
This is a multicenter, non-blinded, randomized control trial involving premature neonates born between 23 0/7 and 29 6/7 weeks gestational age. The trial will take place in four Neonatal Intensive Care Units (NICUs) within the Rady Children's/University of California, San Diego network, including Rady Children's Hospital - San Diego, Jacobs Medical Center, Scripps La Jolla (Rady NICU) and Rancho Springs (Rady NICU). The investigators aim to recruit 130 infants, a target sample size determined based on retrospective data from all of the participating units.
Examination of CPAP failure rates in babies < 28 weeks who were weaned off CPAP before 34 weeks CGA revealed a 62.5% failure rate, whereas those who remained on CPAP at or beyond 34 weeks exhibited a 26.7% failure rate. Thus, the investigators selected 34 weeks CGA as the time point for maintaining CPAP in babies < 28 weeks GA. For infants > 28 weeks, the retrospective review demonstrated a 76% failure rate if weaned off CPAP before 32 weeks, while those who remained on CPAP at or beyond 32 weeks showed an 11% failure rate. Consequently, the investigators chose 32 weeks CGA as the designated time point for continuing CPAP in babies with a GA of 28-30 weeks.
The sample size calculation employed a two-independent- study-group design with a primary endpoint of a binomial outcome (failed CPAP wean, yes/no). The investigators set the alpha error rate at 0.05 and power at 80%. To achieve a 50% reduction in the CPAP weaning failure rate, they aimed to enroll a total of 80 infants < 28 weeks and 50 infants 28-30 weeks (130 infants in total).
Consent will be obtained after the eligible infant has been extubated or has been stable on NIS (defined as CPAP/NIMV/NIPPV- all modes of pressure reliant respiratory support) for over 72 hours. NIS is delivered via occlusive (Fischer & Paykel [F&P]) or non-occlusive (RAM TM/Nioflo TM) interfaces at any pressure and oxygen need.
A standardized maintenance/weaning protocol will be implemented for the treatment group (standardized NIS wean) while the control group (routine care) will undergo weaning based on unit-specific practices. All infants in the treatment group will remain on CPAP until either 32 or 34 weeks CGA, depending on their GA age at birth. Infants born at 27 6/7 weeks or less will continue on CPAP until at least 34 weeks CGA if they are in the treatment group, whereas infants born at 28 0/7 to 29 6/7 will stay on CPAP until at least 32 weeks in the treatment group. The weaning protocol in the treatment group will incorporate algorithms outlining stability criteria, failure criteria, and algorithms for registered nurses (RN) and respiratory therapists (RT), including steps to take in such situations. The control group will be weaned according to the unit's or medical team's practices. According to the retrospective chart review, no standardized weaning practices have been identified at any of the sites, with decisions primarily driven by the medical team caring for the infant.
The treatment group algorithm will contain the following features:
◦ The algorithm will specify the type of NIS to use, outline how to assess the infant every 24 hours, and provide guidance on whether to wean, maintain, or increase support based on the following 3 questions:
Within the last 24 hours:
If the answer is 'yes' to all 3 questions, the provider can begin to wean the infant according to the algorithm's recommendations. If the answer to any of the questions is 'no', the NIS will be maintained. In the event of clinical instability, the support can be increased.
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130 participants in 2 patient groups
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Sarah Lazar, MPH; Sandra Leibel, MD
Data sourced from clinicaltrials.gov
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