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| Name | Class |
|---|---|
| Children's Hospital of Orange County | OTHER |
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Though Nasal Continuous Positive Airway Pressure (NCPAP) is a commonly used form of non-invasive neonatal respiratory support, the optimal method of weaning off NCPAP is not well established. In this prospective, two-center randomized control trial we hypothesize that gradually increasing time off NCPAP (sprinting) increases the success of weaning NCPAP off in infants born between 23 0/7-30 6/7 weeks of gestational age.
Eligible infants admitted to two Neonatal Intensive Care Units (NICUs) were randomized to a sprinting (SP) vs. a non-sprinting (NSP) protocol, both over 4 days. Infants assigned to the SP group sprinted twice daily for 3h (day 1), 6h (day 2), 9h (day 3) & then 24h back on NCPAP (day 4) before switching to nasal cannula (NC) on day 5. Infants in the NSP group were maintained on NCPAP of 5 cm of water for the first 4 days before switching to NC on day 5, similar to the SP group. Infants in both groups were observed for the next 3 days (day 5-7) to ensure stability off CPAP
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sprinting | Experimental | Take off NCPAP twice daily for 3hours (day 1), Take off NCPAP twice daily for 6hours (day 2), Take off NCPAP twice daily for 9hours (day 3), Placed back on NCPAP for 24hours (day 4), Switch to nasal cannula at a flow rate of 1.5-2 L/min (day 5) |
|
| Non-Sprinting | Active Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NCPAP | Device | Nasal Continuous Positive Airway Pressure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Successful Wean Off CPAP at the First Attempt | Measured by successful wean off CPAP on first attempt, i.e., no NCPAP requirement after 7 days on wean protocol on first attempt. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Bronchopulmonary Dysplasia | Measured as an oxygen requirement at 36 weeks corrected gestational age | 1-2 months |
| Number of Participants With Retinopathy of Prematurity (ROP) |
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Inclusion Criteria:
Initiation of study protocol, i.e., weaning from NCPAP, was started when infant met all of the following criteria for at least 24 hours:
Requiring NCPAP of 4-6 cm of H2O and FiO2 ≤0.3.
All babies < 32 weeks corrected GA should have been loaded or already on maintenance caffeine (caffeine citrate 20 mg/kg as the loading and 5-10 mg/kg as the maintenance dose).
Stable respiratory system assessment (respiratory rate of < 70/min, no significant chest retractions (sternal/ diaphragmatic), and baseline oxygen saturation > 86%) and otherwise deemed clinically stable for weaning off non-invasive ventilation by medical team
If post-surgery, infant must be at least 2 weeks post-operative and off antibiotics with no concern or need for repeat surgery.
A documented hemoglobin of more than 8 g/dl within 7 days of initiation of the study.
Meeting "stability criteria" defined below:
Exclusion Criteria:
Evidence of a hemodynamically or clinically significant (worsening respiratory status or pulmonary edema on chest x-ray) Patent ductus arteriosus, diagnosed either clinically or echocardiographically.
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| Name | Affiliation | Role |
|---|---|---|
| Virender Rehan, MD | University of California, Los Angeles | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20472939 | Background | SUPPORT Study Group of the Eunice Kennedy Shriver NICHD Neonatal Research Network; Finer NN, Carlo WA, Walsh MC, Rich W, Gantz MG, Laptook AR, Yoder BA, Faix RG, Das A, Poole WK, Donovan EF, Newman NS, Ambalavanan N, Frantz ID 3rd, Buchter S, Sanchez PJ, Kennedy KA, Laroia N, Poindexter BB, Cotten CM, Van Meurs KP, Duara S, Narendran V, Sood BG, O'Shea TM, Bell EF, Bhandari V, Watterberg KL, Higgins RD. Early CPAP versus surfactant in extremely preterm infants. N Engl J Med. 2010 May 27;362(21):1970-9. doi: 10.1056/NEJMoa0911783. Epub 2010 May 16. | |
| 15342835 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sprinting | Take off NCPAP twice daily for 3hours (day 1), Take off NCPAP twice daily for 6hours (day 2), Take off NCPAP twice daily for 9hours (day 3), Placed back on NCPAP for 24hours (day 4), Switch to nasal cannula at a flow rate of 1.5-2 L/min (day 5) NCPAP: Nasal Continuous Positive Airway Pressure |
| FG001 | Non-Sprinting |
NCPAP: Nasal Continuous Positive Airway Pressure |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sprinting | Take off NCPAP twice daily for 3hours (day 1), Take off NCPAP twice daily for 6hours (day 2), Take off NCPAP twice daily for 9hours (day 3), Placed back on NCPAP for 24hours (day 4), Switch to nasal cannula at a flow rate of 1.5-2 L/min (day 5) NCPAP: Nasal Continuous Positive Airway Pressure |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Successful Wean Off CPAP at the First Attempt | Measured by successful wean off CPAP on first attempt, i.e., no NCPAP requirement after 7 days on wean protocol on first attempt. | Posted | Count of Participants | Participants | 7 days |
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sprinting | Take off NCPAP twice daily for 3hours (day 1), Take off NCPAP twice daily for 6hours (day 2), Take off NCPAP twice daily for 9hours (day 3), Placed back on NCPAP for 24hours (day 4), Switch to nasal cannula at a flow rate of 1.5-2 L/min (day 5) NCPAP: Nasal Continuous Positive Airway Pressure |
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Limitations:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Virender Rehan | Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center | 3102221965 | vrehan@labiomed.org |
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| ID | Term |
|---|---|
| D012127 | Respiratory Distress Syndrome, Newborn |
| D001997 | Bronchopulmonary Dysplasia |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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Measured as clinical signs of stage 2 or above ROP on retinal exam prior to discharge
| 1-2 months |
| Number of Participants With Periventricular Leukomalacia (PVL) | Measured as radiologic findings of PVL noted prior to discharge | 1-2 months |
| Length of Stay (Days) | Measures as the number of days patient remained hospitalized after birth at the study hospital. | 60-108 days |
| Corrected Gestational Age at Time of Discharge/Transfer | Measured as the corrected gestational age at which the patient was discharged or transferred. | 36weeks-41weeks |
| Number of Attempts to Wean Off CPAP | Number of attempts made to wean off CPAP | Until completely weaned off CPAP |
| Number of Days on Protocol | Measured as the total number of days the patient was on the study protocol | 7-10 days |
| Background |
| Finer NN, Carlo WA, Duara S, Fanaroff AA, Donovan EF, Wright LL, Kandefer S, Poole WK; National Institute of Child Health and Human Development Neonatal Research Network. Delivery room continuous positive airway pressure/positive end-expiratory pressure in extremely low birth weight infants: a feasibility trial. Pediatrics. 2004 Sep;114(3):651-7. doi: 10.1542/peds.2004-0394. |
| 23268664 | Background | Vaucher YE, Peralta-Carcelen M, Finer NN, Carlo WA, Gantz MG, Walsh MC, Laptook AR, Yoder BA, Faix RG, Das A, Schibler K, Rich W, Newman NS, Vohr BR, Yolton K, Heyne RJ, Wilson-Costello DE, Evans PW, Goldstein RF, Acarregui MJ, Adams-Chapman I, Pappas A, Hintz SR, Poindexter B, Dusick AM, McGowan EC, Ehrenkranz RA, Bodnar A, Bauer CR, Fuller J, O'Shea TM, Myers GJ, Higgins RD; SUPPORT Study Group of the Eunice Kennedy Shriver NICHD Neonatal Research Network. Neurodevelopmental outcomes in the early CPAP and pulse oximetry trial. N Engl J Med. 2012 Dec 27;367(26):2495-504. doi: 10.1056/NEJMoa1208506. |
| Background | Singh SD, Bowe L, Clarke P, Glover K, Pasquill A R, MJ et al. Is decreasing pressure or increasing time off the better strategy in weaning VLBW infants from nasal CPAP? Eur J Pediatr B Abstr Eur Acad Pediatr. 2006;Abstract. |
| Background | A Soe, J Hodgkinson, B Jani DAD. Nasal continous positive airway pressure weaning in preterm infants. Eur J Pediatr B Abstr Eur Acad Pediatr. 2006;Abstract. |
| 22611116 | Background | Todd DA, Wright A, Broom M, Chauhan M, Meskell S, Cameron C, Perdomi AM, Rochefort M, Jardine L, Stewart A, Shadbolt B. Methods of weaning preterm babies <30 weeks gestation off CPAP: a multicentre randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2012 Jul;97(4):F236-40. doi: 10.1136/adc.2011-300133. Epub 2012 May 18. |
| 21328289 | Background | Jardine LA, Inglis GD, Davies MW. Strategies for the withdrawal of nasal continuous positive airway pressure (NCPAP) in preterm infants. Cochrane Database Syst Rev. 2011 Feb 16;(2):CD006979. doi: 10.1002/14651858.CD006979.pub2. |
| 22187570 | Background | Rastogi S, Rajasekhar H, Gupta A, Bhutada A, Rastogi D, Wung JT. Factors Affecting the Weaning from Nasal CPAP in Preterm Neonates. Int J Pediatr. 2012;2012:416073. doi: 10.1155/2012/416073. Epub 2011 Dec 8. |
| 22906960 | Background | Rastogi S, Wong W, Gupta A, Bhutada A; Deepa Rastogi; Maimonides Neonatal Group. Gradual versus sudden weaning from nasal CPAP in preterm infants: a pilot randomized controlled trial. Respir Care. 2013 Mar;58(3):511-6. doi: 10.4187/respcare.01999. |
| 29072676 | Derived | Eze N, Murphy D, Dhar V, Rehan VK. Comparison of sprinting vs non-sprinting to wean nasal continuous positive airway pressure off in very preterm infants. J Perinatol. 2018 Feb;38(2):164-168. doi: 10.1038/jp.2017.161. Epub 2017 Oct 26. |
| Non-Sprinting |
NCPAP: Nasal Continuous Positive Airway Pressure |
| BG002 | Total | Total of all reporting groups |
| Weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Number of Participants With Bronchopulmonary Dysplasia | Measured as an oxygen requirement at 36 weeks corrected gestational age | Posted | Count of Participants | Participants | 1-2 months |
|
|
|
| Secondary | Number of Participants With Retinopathy of Prematurity (ROP) | Measured as clinical signs of stage 2 or above ROP on retinal exam prior to discharge | Posted | Count of Participants | Participants | 1-2 months |
|
|
|
| Secondary | Number of Participants With Periventricular Leukomalacia (PVL) | Measured as radiologic findings of PVL noted prior to discharge | Posted | Count of Participants | Participants | 1-2 months |
|
|
|
| Secondary | Length of Stay (Days) | Measures as the number of days patient remained hospitalized after birth at the study hospital. | Posted | Median | Full Range | Days | 60-108 days |
|
|
|
| Secondary | Corrected Gestational Age at Time of Discharge/Transfer | Measured as the corrected gestational age at which the patient was discharged or transferred. | Posted | Median | Full Range | weeks | 36weeks-41weeks |
|
|
|
| Secondary | Number of Attempts to Wean Off CPAP | Number of attempts made to wean off CPAP | Posted | Median | Full Range | Attempt | Until completely weaned off CPAP |
|
|
|
| Secondary | Number of Days on Protocol | Measured as the total number of days the patient was on the study protocol | Posted | Median | Full Range | Days | 7-10 days |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Non-Sprinting |
NCPAP: Nasal Continuous Positive Airway Pressure | 0 | 40 | 0 | 40 | 0 | 40 |
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| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |