Flow and Grow - The Ideal Time to Wean CPAP Off In Extremely Low Birth Weight Infants

NCT06123143 | Recruiting

• 1 other identifier: 807423
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 5

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

Keywords

Neonatal; CPAP

Outcome Measures

Primary Outcomes (1)

• Number of participants with CPAP/NIS weaning failure

  Number of participants needing more support and/or with increased sleep stimulation events after weaning off of CPAP/NIS.

  72 hours after weaning off of CPAP

Secondary Outcomes (16)

• 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 postnatal steroids

  Through study completion, an average of 4 months

• Use of antibiotics

  Through study completion, an average of 4 months

Study Arms (2)

Standardized NIS Wean

EXPERIMENTAL

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.

Other: Standardized/structured CPAP weaning protocol

Control

NO INTERVENTION

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

Interventions

Standardized/structured CPAP weaning protocol OTHER

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.

Standardized NIS Wean

Eligibility Criteria

• Age: Up to 30 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All infants admitted to the NICU at Jacobs, Rancho Springs, Scripps La Jolla, Rady Children's Hospital, or Palomar born at \< 30 weeks CGA
• Informed parental consent obtained

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, San Diego: lead
• Rady Children's Hospital, San Diego: collaborator

Study Sites (5)

Palomar Medical Center Rady NICU

Escondido, California, 92029, United States

RECRUITING

Scripps La Jolla Rady NICU

La Jolla, California, 92037, United States

RECRUITING

University of California, San Diego Jacobs Medical Center

La Jolla, California, 92037, United States

RECRUITING

Rancho Springs Medical Center Rady NICU

Murrieta, California, 92562, United States

RECRUITING

Rady Children's Hospital-San Diego

San Diego, California, 92123, United States

RECRUITING

Study Officials

• Sandra Leibel, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandra Leibel, MD

CONTACT

858-249-1702; saleibel@health.ucsd.edu

Sarah Lazar, MPH

CONTACT

858-249-1711; slazar@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clinical Professor

Model Details: 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 gestational age at birth. Infants born at 27 6/7 weeks or less will continue on CPAP 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 CPAP 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.

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: November 8, 2023
• Study Start: November 27, 2023
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Immediately following publication and ending 24 months following article publication.
• Access Criteria: Proposals for access may be submitted up to 24 months following article publication. After 24 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata.

Locations

US (5)