Flow and Grow - A CPAP Management Strategy for Preterm Infants to Support Lung Growth. A Randomized, Prospective, Multi-center Study
University of California, San Diego
Summary
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.
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 five 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), Rancho Springs (Rady NICU), and Palomar (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…
Eligibility
- Age range
- Up to 0 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. All infants admitted to the NICU at Jacobs, Rancho Springs, Scripps La Jolla, Rady Children's Hospital, or Palomar born at \< 30 weeks CGA 2. Informed parental consent obtained Exclusion Criteria: 1. Declined or unable to give informed consent 2. 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) 3. Intubated for over 4 weeks of life (28 days)
Interventions
- OtherStandardized/structured CPAP weaning protocol
Standardized/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.
Locations (5)
- Palomar Medical Center Rady NICUEscondido, California
- Scripps La Jolla Rady NICULa Jolla, California
- University of California, San Diego Jacobs Medical CenterLa Jolla, California
- Rancho Springs Medical Center Rady NICUMurrieta, California
- Rady Children's Hospital-San DiegoSan Diego, California