Structured CPAP Weaning for Neonatal Respiratory Failure
(Flow&Grow Trial)
Recruiting in Palo Alto (17 mi)
+3 other locations
Overseen BySandra Leibel, MD
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, San Diego
Disqualifiers: Congenital anomalies, NEC, SIP, others
No Placebo Group
Approved in 1 jurisdiction
Trial Summary
What is the purpose of 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.
Do I have to stop my current medications for the trial?
The trial information does not specify whether participants need to stop taking their current medications.
What data supports the effectiveness of the treatment Structured CPAP Weaning for Neonatal Respiratory Failure?
Research shows that using a structured approach to wean premature infants from CPAP (a breathing support machine) is feasible, but there were no significant differences in short-term breathing outcomes compared to non-standardized methods. More research is needed to determine the best weaning strategy.
12345Is structured CPAP weaning safe for humans?
The research articles focus on methods for weaning preterm infants from CPAP, but they do not provide specific safety data. However, CPAP is widely used in preterm infants, suggesting it is generally considered safe in this population.
24678How is the Structured CPAP Weaning treatment different from other treatments for neonatal respiratory failure?
The Structured CPAP Weaning treatment is unique because it uses a standardized protocol to gradually reduce the use of continuous positive airway pressure (CPAP) in infants, unlike other methods that may not follow a specific plan. This approach aims to provide a more consistent and potentially more effective way to help infants transition off CPAP support.
14789Eligibility Criteria
This trial is for preterm infants born at less than 30 weeks' gestational age who are in the NICU and have not been intubated for over 4 weeks. Infants with long-term support needs due to conditions like pulmonary hypoplasia or genetic syndromes cannot participate.Inclusion Criteria
Informed parental consent obtained
Babies born at less than 30 weeks of pregnancy and admitted to specific hospitals' neonatal intensive care units.
Exclusion Criteria
Declined or unable to give informed consent
I have been on a breathing machine for more than 4 weeks.
My infant has a long-term health condition needing support, like breathing issues or genetic syndromes.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Infants receive non-invasive respiratory support (NIS) with a structured weaning protocol until 32-34 weeks corrected gestational age (CGA), depending on gestational age at birth.
9-11 weeks
Weaning
Infants are weaned off CPAP/NIS following a standardized protocol or unit-specific practices.
72 hours
Follow-up
Participants are monitored for safety and effectiveness after weaning off CPAP/NIS.
4 months
Participant Groups
The study tests a structured weaning protocol from CPAP, hypothesizing that maintaining it until at least 32-34 weeks corrected gestational age will reduce weaning failure compared to standard care.
2Treatment groups
Experimental Treatment
Active Control
Group I: Standardized NIS WeanExperimental Treatment1 Intervention
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.
Group II: ControlActive Control1 Intervention
Babies in the control group (non-standardized wean) will be weaned based on unit specific practices.
Standardized/structured CPAP weaning protocol is already approved in United States for the following indications:
🇺🇸 Approved in United States as Standardized CPAP weaning protocol for:
- Prevention of chronic lung disease in preterm infants
- Reduction of weaning failure in preterm infants
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Rancho Springs Medical Center Rady NICUMurrieta, CA
Scripps La Jolla Rady NICULa Jolla, CA
Rady Children's Hospital-San DiegoSan Diego, CA
University of California, San Diego Jacobs Medical CenterLa Jolla, CA
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Who Is Running the Clinical Trial?
University of California, San DiegoLead Sponsor
Rady Children's Hospital, San DiegoCollaborator
References
Standardized weaning of infants [2019]The practice of weaning premature infants from continuous positive airway pressure (CPAP) varies considerably and is usually performed without written standards. In this study, the feasibility of a standardized weaning approach was evaluated. In a quasi-experimental design, data from a prospective, post-intervention cohort (n=41) were compared to data from a pre-intervention cohort (n=36). Standardized weaning was feasible but no significant differences in short-term respiratory outcomes were observed. Weaning from CPAP was achieved at 32.1 ± 1.6 (post-intervention) versus 32.5 ± 2.3 weeks (pre-intervention) postmenstrual age. More rigorous, large-scale clinical trials are necessary before firm recommendations on distinct weaning regimens can be made.
A randomized pilot study comparing the role of PEEP, O2 flow, and high-flow air for weaning of ventilatory support in very low birth weight infants. [2019]There is a lack of evidence to guide step-wise weaning of positive pressure respiratory support for premature infants. This study sought to compare the efficacy of three weaning protocols we designed to facilitate weaning of very low birth weight (VLBW, less than 1500 g) preterm infants from nasal continuous positive airway pressure (NCPAP) support.
High flow nasal cannula as a method for rapid weaning from nasal continuous positive airway pressure. [2020]To compare two methods of weaning premature infants from nasal continuous positive airway pressure (NCPAP).
Comparison of sprinting vs non-sprinting to wean nasal continuous positive airway pressure off in very preterm infants. [2019]Though nasal continuous positive airway pressure (NCPAP) is commonly used for non-invasive neonatal respiratory support, the optimal method of weaning NCPAP is not established. In this prospective, two-center randomized control trial we hypothesize that gradually increasing spontaneous breathing time off NCPAP increases successful weaning from NCPAP in infants born
Randomised controlled trial of weaning strategies for preterm infants on nasal continuous positive airway pressure. [2018]The optimal strategy for weaning very preterm infants from nasal continuous positive airway pressure (NCPAP) is unclear. Reported strategies include weaning NCPAP to a predefined pressure then trialling stopping completely (abrupt wean); alternate periods of increased time off NCPAP whilst reducing time on until the infant is completely weaned (gradual wean); and using high flow nasal cannula (HFNC) to assist the weaning process. The aim of this study was to determine the optimal weaning from NCPAP strategy for very preterm infants.
Oxygen saturation histograms predict nasal continuous positive airway pressure-weaning success in preterm infants. [2021]Continuous positive airway pressure (CPAP) is widely used in preterm infants. Identification of readiness for weaning from CPAP can balance benefits with risks of CPAP exposure. We tested the hypothesis that preterm infants that successfully transition off CPAP have higher oxygen saturations prior to weaning compared with infants who fail weaning from CPAP.
Implementation of a protocol-based strategy for weaning nasal high flow therapy in preterm infants. [2021]We compared protocolized weaning versus nonprotocolized weaning practice from nasal high flow therapy (nHFT) in preterm infants.
Gradual versus sudden weaning from nasal CPAP in preterm infants: a pilot randomized controlled trial. [2013]There is paucity of information on the weaning of nasal CPAP (NCPAP) in preterm infants. As the weaning from NCPAP can be gradual or sudden, we wanted to determine which of the 2 methods was better.
[Weaning newborns from noninvasive ventilation]. [2014]The purpose of the study was to propose the recommendations for weaning infants from nasal continuous positive airway pressure (nCPAP) and nasal intermittent positive pressure ventilation (NIPPV). Despite the fact that both methods are commonly used for respiratory insufficiency in infants, detailed recommendations for weaning have not been described so far. The proposed recommendations are based on previously described data and a wide survey conducted among Polish neonatologists and intensive therapy paediatricians.