Effective Approaches & Strategies to Ease Off Nasal CPAP In Preterm Infants
NCT ID: NCT02819050
Last Updated: 2021-12-10
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2014-01-31
2016-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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
Non-Sprinting
* If the infant was on NCPAP 6, Infant was weaned down to CPAP 5 for 96 hours. If they met stability criteria, then infant was switched to room air (no flow) or no more than 2L NC.
* If the infant was on NCPAP 5, the infant was continued on CPAP 5 for 96 hours If they met stability criteria, then infant was switched to room air (no flow) or no more than 2L NC.
NCPAP
Nasal Continuous Positive Airway Pressure
Interventions
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NCPAP
Nasal Continuous Positive Airway Pressure
Eligibility Criteria
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Inclusion Criteria
* At least 26 0/7 weeks corrected GA.
* On NCPAP for at least 24 hours
* Stable on ≤0.3 FiO2 for at least 24 hours
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:
* The infant had to be tolerating a flow of no more than 2 liters NC on a FiO2 of 0.30 or less to keep oxygen saturations above 85% (should match what you wrote below in failure criteria)%.
* Have a respiratory rate of less than 70 on average over 24 hours for more than 24 hours
* The infant could have no significant chest recession (sternal/diaphragmatic)
Exclusion Criteria
* Any significant congenital abnormality (abnormalities affecting a major organ system, airway, or musculoskeletal system).
* Hemodynamic/respiratory instability or currently being treated for suspected or proven sepsis (positive blood culture)
* Grade IV intraventricular hemorrhage
* Inability to obtain informed parental consent
26 Weeks
ALL
No
Sponsors
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Children's Hospital of Orange County
OTHER
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
OTHER
Responsible Party
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Virender Rehan, MD
Chair, Department of Neonatology
Principal Investigators
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Virender Rehan, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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30166-01
Identifier Type: -
Identifier Source: org_study_id