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The purpose of this study is to determine an optimal strategy to wean nasal continuous positive airway pressure (NCPAP) in preterm babies. The investigators hypothesize that babies that are taken off NCPAP at lower settings will need fewer total days on NCPAP than those babies taken off at higher settings.
This is a prospective randomized control trial to investigate an optimal method for discontinuing NCPAP therapy in preterm neonates. Neonates ≤32 weeks gestational age (GA) who require NCPAP in the delivery room or following extubation and are delivered in or transferred to Parkland Hospital Neonatal Intensive Care Unit (NICU) will be enrolled. The study team will approach the parents for verbal consent once neonates are stable on mechanical ventilation with a goal of extubation to NCPAP or once they are placed on initial NCPAP therapy. Neonates will be randomized to the high or low NCPAP arms and managed by their primary care team until they meet stability criteria as defined for a minimum of 12 hours. At that time they will be removed from NCPAP using two approaches: Group 1 will be decreased to 5cm H2O by the primary care team at which time NCPAP is removed if the neonate is clinically stable and the neonate placed in room air or on low-flow nasal cannula at ≤1L/min; Group 2 will be gradually weaned to a NCPAP of 3cm H2O at which time NCPAP is removed if the neonate is clinically stable for the prior 24 hours and the neonate placed in room air or on low-flow nasal cannula. Failure criteria will consist of clinical signs and laboratory results demonstrating the need for escalation of support, e.g., increasing apnea of prematurity (AOP) or need for increasing O2 supplementation. When a neonate has been stable for 5 days off NCPAP, they will complete the intervention arm of the study. All neonates will be followed until discharge, at which time the primary outcomes, e.g., days on NCPAP, duration of hospitalization and need for O2, will be determined for each group and compared. The calculated total sample size will require 238 neonates; i.e., 113 neonates per arm with a 5% drop-out rate will give a power of 0.80 and alpha value of 0.05 to detect a 25% difference in NCPAP days.
Stability Criteria:
Failure Criteria:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low CPAP Wean | Active Comparator | NCPAP weaned to 5cm H2O for minimum of 24h, and if the neonate remains clinically stable as defined, wean in 1cm increments to 3cm H2O for minimum of 24h, at which time move to room air or 1L/min nasal cannula if supplemental O2 is required. |
|
| High CPAP Wean | Active Comparator | NCPAP weaned to 5cm H2O for a minimum of 24h, and if the neonate remains clinically stable, move to room air or 1L/min nasal cannula if supplemental O2 is required. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low CPAP Wean | Other | Infants receive NCPAP by Hudson nasal prongs. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Total days of NCPAP | Total number of days of CPAP therapy during the hospital stay | Until hospital discharge or 1 year of life |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay | Number of days spent prior to being discharged from the hospital | Until hospital discharge or 1 year of life |
| Duration of oxygen supplementation | Number of days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Venkat Kakkilaya, MD | UT Southwestern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parkland Memorial Hospital | Dallas | Texas | 75235 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33127365 | Derived | Kakkilaya V, Tang A, Wagner S, Ridpath J, Ibrahim J, Brown LS, Rosenfeld CR. Discontinuing Nasal Continuous Positive Airway Pressure in Infants </=32 Weeks of Gestational Age: A Randomized Control Trial. J Pediatr. 2021 Mar;230:93-99.e3. doi: 10.1016/j.jpeds.2020.10.045. Epub 2020 Oct 28. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| High CPAP Wean |
| Other |
Infants receive NCPAP by Hudson nasal prongs. |
|
| Until hospital discharge or 1 year of life |
| D000091642 | Urogenital Diseases |