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

NCT06123143 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2026-01-20

No results posted yet for this study

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

Interventions

OTHER

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.

Sponsors & Collaborators

Principal Investigators

  • Sandra Leibel, MD · University of California, San Diego

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
30 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-27
Primary Completion
2028-11-30
Completion
2028-11-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06123143 on ClinicalTrials.gov