Effectiveness of Bubble Nasal Continuous Positive Airway Pressure (bCPAP) in Neonatal Respiratory Distress
NCT ID: NCT04401696
Last Updated: 2020-05-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2017-04-01
2018-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A
Use of Bubble CPAP for management of respiratory distress
Bubble CPAP
The bCPAP will be delivered using an oxygen flow meter as the oxygen source. This inspiratory limb containing oxygen from the flow meter will be connected to humidifier and tubing from humidifier will be connected to short binasal prongs, which would be applied to neonate with the help of adhesive bandage on both cheeks. It will be ensured that binasal prongs make appropriate seal. An orogastric tube will be placed for gastric decompression. A 1000 ml/500ml bottle filled with sterile water be used and marks will be made on it at 1cm distance, with '10' marked at base and '0' mark at the water interface.
The expiratory limb from the nasal prongs was connected to tubing that will be dipped in water up to the desired level to provide positive end expiratory pressure. Pressure is varied by varying the depth of the dipped end of tubing.
Group B
Use of Oxygen via nasal cannula for respiratory distress
Nasal Oxygen
The oxygen will be delivered from a wall oxygen source, delivered between 1 to 6 L/min and the rate varied via a flow regulator.
Interventions
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Bubble CPAP
The bCPAP will be delivered using an oxygen flow meter as the oxygen source. This inspiratory limb containing oxygen from the flow meter will be connected to humidifier and tubing from humidifier will be connected to short binasal prongs, which would be applied to neonate with the help of adhesive bandage on both cheeks. It will be ensured that binasal prongs make appropriate seal. An orogastric tube will be placed for gastric decompression. A 1000 ml/500ml bottle filled with sterile water be used and marks will be made on it at 1cm distance, with '10' marked at base and '0' mark at the water interface.
The expiratory limb from the nasal prongs was connected to tubing that will be dipped in water up to the desired level to provide positive end expiratory pressure. Pressure is varied by varying the depth of the dipped end of tubing.
Nasal Oxygen
The oxygen will be delivered from a wall oxygen source, delivered between 1 to 6 L/min and the rate varied via a flow regulator.
Eligibility Criteria
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Inclusion Criteria
* Gender- both male and female
* Gestational ages ≥32 weeks
* Having respiratory distress (as per the operational definition- respiratory rate \>60/min plus any of the following features: grunting, subcostal/intercostal retractions, nasal flaring, inability to maintain spO2 \>90% at room air)
* Silverman Anderson Retraction Score ≥4
Exclusion Criteria
* Birth weight less than 1.5 kg
* Neonates having congenital malformations, air leak syndromes, hypoxic ischemic encephalopathy
* Neonates requiring mechanical ventilation at the time of admission
1 Hour
28 Days
ALL
No
Sponsors
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King Edward Medical University
OTHER
Responsible Party
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Tehreem Fatima
Tehreem Fatima, Senior Registrar, Children Hospital & ICH Faisalabad.
Principal Investigators
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Tehreem Fatima, FCPS
Role: PRINCIPAL_INVESTIGATOR
King Edward Medical University
Locations
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King Edward Medical University/ Mayo Hospital Lahore
Lahore, Punjab Province, Pakistan
Countries
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References
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Chen A, Deshmukh AA, Richards-Kortum R, Molyneux E, Kawaza K, Cantor SB. Cost-effectiveness analysis of a low-cost bubble CPAP device in providing ventilatory support for neonates in Malawi - a preliminary report. BMC Pediatr. 2014 Nov 25;14:288. doi: 10.1186/s12887-014-0288-1.
Mustufa MA, Korejo R, Shahid A, Nasim S. Infection remains a leading cause of neonatal mortality among infants delivered at a tertiary hospital in Karachi, Pakistan. J Infect Dev Ctries. 2014 Sep 13;8(11):1470-5. doi: 10.3855/jidc.3569.
Daga S, Mhatre S, Borhade A, Khan D. Home-made continuous positive airways pressure device may reduce mortality in neonates with respiratory distress in low-resource setting. J Trop Pediatr. 2014 Oct;60(5):343-7. doi: 10.1093/tropej/fmu023. Epub 2014 Apr 23.
Kawaza K, Machen HE, Brown J, Mwanza Z, Iniguez S, Gest A, Smith EO, Oden M, Richards-Kortum RR, Molyneux E. Efficacy of a low-cost bubble CPAP system in treatment of respiratory distress in a neonatal ward in Malawi. PLoS One. 2014 Jan 29;9(1):e86327. doi: 10.1371/journal.pone.0086327. eCollection 2014.
Brown J, Machen H, Kawaza K, Mwanza Z, Iniguez S, Lang H, Gest A, Kennedy N, Miros R, Richards-Kortum R, Molyneux E, Oden M. A high-value, low-cost bubble continuous positive airway pressure system for low-resource settings: technical assessment and initial case reports. PLoS One. 2013;8(1):e53622. doi: 10.1371/journal.pone.0053622. Epub 2013 Jan 23.
Stoll BJ, Hansen NI, Bell EF, Walsh MC, Carlo WA, Shankaran S, Laptook AR, Sanchez PJ, Van Meurs KP, Wyckoff M, Das A, Hale EC, Ball MB, Newman NS, Schibler K, Poindexter BB, Kennedy KA, Cotten CM, Watterberg KL, D'Angio CT, DeMauro SB, Truog WE, Devaskar U, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Trends in Care Practices, Morbidity, and Mortality of Extremely Preterm Neonates, 1993-2012. JAMA. 2015 Sep 8;314(10):1039-51. doi: 10.1001/jama.2015.10244.
Hundalani SG, Richards-Kortum R, Oden M, Kawaza K, Gest A, Molyneux E. Development and validation of a simple algorithm for initiation of CPAP in neonates with respiratory distress in Malawi. Arch Dis Child Fetal Neonatal Ed. 2015 Jul;100(4):F332-6. doi: 10.1136/archdischild-2014-308082. Epub 2015 Apr 15.
Kaur C, Sema A, Beri RS, Puliyel JM. A simple circuit to deliver bubbling CPAP. Indian Pediatr. 2008 Apr;45(4):312-4.
Anwaar O, Hussain M, Shakeel M, Ahsan Baig MM. Outcome Of Use Of Nasal Continuous Positive Airway Pressure Through Infant Flow Drivers In Neonates With Respiratory Distress In A Tertiary Care Hospital In Pakistan. J Ayub Med Coll Abbottabad. 2018 Oct-Dec;30(4):511-555.
Hedstrom AB, Gove NE, Mayock DE, Batra M. Performance of the Silverman Andersen Respiratory Severity Score in predicting PCO2 and respiratory support in newborns: a prospective cohort study. J Perinatol. 2018 May;38(5):505-511. doi: 10.1038/s41372-018-0049-3. Epub 2018 Feb 9.
Wilson PT, Baiden F, Brooks JC, Morris MC, Giessler K, Punguyire D, Apio G, Agyeman-Ampromfi A, Lopez-Pintado S, Sylverken J, Nyarko-Jectey K, Tagbor H, Moresky RT. Continuous positive airway pressure for children with undifferentiated respiratory distress in Ghana: an open-label, cluster, crossover trial. Lancet Glob Health. 2017 Jun;5(6):e615-e623. doi: 10.1016/S2214-109X(17)30145-6.
Al-Lawama M, Alkhatib H, Wakileh Z, Elqaisi R, AlMassad G, Badran E, Hartman T. Bubble CPAP therapy for neonatal respiratory distress in level III neonatal unit in Amman, Jordan: a prospective observational study. Int J Gen Med. 2018 Dec 24;12:25-30. doi: 10.2147/IJGM.S185264. eCollection 2019.
Other Identifiers
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BubbleCPAP
Identifier Type: -
Identifier Source: org_study_id
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