Flow and Grow - A CPAP Management Strategy for Preterm Infants to Support Lung Growth. A Randomized, Prospective, Multi-center Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 4
- 主要终点
- Number of participants with CPAP/NIS weaning failure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- — 至 30 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All infants admitted to the NICU at Jacobs, Rancho Springs, Scripps La Jolla, and Rady Children's Hospital born at < 30 weeks CGA
- •Informed parental consent obtained
排除标准
- •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)
研究组 & 干预措施
Standardized NIS Wean
A standardized maintenance/weaning protocol will be implemented for the treatment group (standardized NIS wean). All infants in the treatment group will remain on NIS until either 32 or 34 weeks CGA, depending on their gestational age at birth. Infants born at 27 6/7 weeks or less will continue on NIS until at least 34 weeks if they are in the treatment group, whereas infants born between 28 0/7 and 29 6/7 weeks will stay on NIS until at least 32 weeks if they are in the treatment group. The weaning protocol in the treatment group will incorporate algorithms outlining stability criteria, failure criteria, and algorithms for registered nurses (RNs) and respiratory therapists (RTs), including steps to take in such situations. The control group will be weaned according to the unit's or medical team's practices.
干预措施: Standardized/structured CPAP weaning protocol (Other)
Control
Babies in the control group (non-standardized wean) will be weaned based on unit specific practices.
结局指标
主要结局
Number of participants with CPAP/NIS weaning failure
时间窗: 72 hours after weaning off of CPAP
Number of participants needing more support and/or with increased sleep stimulation events after weaning off of CPAP/NIS.
次要结局
- Number of stimulation events per 24 hours(Through study completion, an average of 4 months)
- Length of hospital stay(Through study completion, an average of 4 months)
- Rate of bronchopulmonary dysplasia(Through study completion, an average of 4 months)
- Use of antibiotics(Through study completion, an average of 4 months)
- Total duration of positive pressure respiratory support(Through study completion, an average of 4 months)
- Number of participants requiring supplemental oxygen(Through study completion, an average of 4 months)
- Number of participants experiencing pulmonary air leaks(Through study completion, an average of 4 months)
- Rate of weight gain(Through study completion, an average of 4 months)
- Use of postnatal steroids(Through study completion, an average of 4 months)
- Number of participants with nasal deformities(Through study completion, an average of 4 months)
- Time to establish full tube feeds(Through study completion, an average of 4 months)
- Time to establish full oral feeds(Through study completion, an average of 4 months)
- Number of participants with nosocomial infections(Through study completion, an average of 4 months)
- Number of participants with intraventricular haemorrhage (IVH) grade III-IV and/or periventricular leukomalacia (PVL) and/or ventriculomegaly on cranial ultrasound.(Through study completion, an average of 4 months)
- Number of participants with retinopathy of prematurity (ROP)(Through study completion, an average of 4 months)
- Number of participants with a need for re-intubation(Through study completion, an average of 4 months)
研究者
Sandra Leibel
Associate Clinical Professor
University of California, San Diego