Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT06123143

Conditions

Neonatal Respiratory Failure

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Standardized/structured CPAP weaning protocol

Study Details

Brief 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.

Conditions

Neonatal Respiratory Failure

Study ID

NCT06123143

Start date

Nov 27, 2023

Status verified date

Jan, 2026

Completion date

Nov, 2028

Anticipated

Primary completion date

Nov, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

130 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 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.

no intervention: Control

Babies in the control group (non-standardized wean) will be weaned based on unit specific practices.

Interventions

Standardized/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.

Primary outcome measure

  • Number of participants with CPAP/NIS weaning failure [ Time Frame: 72 hours after weaning off of CPAP ]

Central Contacts and Locations

Central contacts

Locations

Palomar Medical Center Rady NICU

Recruiting

Escondido, California, United States, 92029

Contacts

Scripps La Jolla Rady NICU

Recruiting

La Jolla, California, United States, 92037

Contacts

University of California, San Diego Jacobs Medical Center

Recruiting

La Jolla, California, United States, 92037

Contacts

Rancho Springs Medical Center Rady NICU

Recruiting

Murrieta, California, United States, 92562

Contacts

Rady Children's Hospital-San Diego

Recruiting

San Diego, California, United States, 92123

Contacts

More Information

Sponsor

University of California, San Diego

Last update posted

Jan 20, 2026

Last verified

Jan, 2026

Keywords

  • Neonatal
  • CPAP

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2026-01-20.