- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04401696
Effectiveness of Bubble Nasal Continuous Positive Airway Pressure (bCPAP) in Neonatal Respiratory Distress (bCPAP)
Comparison of Bubble Nasal Continuous Positive Airway Pressure (bCPAP) Versus Control in Neonates With Respiratory Distress
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab
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Lahore, Punjab, Pakistan, 54000
- King Edward Medical University/ Mayo Hospital Lahore
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients having age 28 days of life or younger (Neonates)
- 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:
- Neonates having gestational age less than 32 weeks
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A
Use of Bubble CPAP for management of respiratory distress
|
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. |
Active Comparator: Group B
Use of Oxygen via nasal cannula for respiratory distress
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effectiveness of Bubble CPAP determined by improvement in Silvermann Anderson Retraction Score
Time Frame: 48 hours since application of intervention
|
Neonates in both groups will be followed-up for 48 hours.
SAR Score will be recorded at 0 and 48 hours.
It consists of five components: (1) chest retractions (2) retraction of the lower intercostal muscles (3) xiphoid retractions (4) flaring of nares with inhalation (5) grunting on exhalation.
Each of the five factors is graded 0, 1 and 2. The sum of these factors yields the total score; minimum score is '0' and maximum score is '10'.
The higher the score, the greater is the severity of respiratory distress.
So the severity of respiratory distress can be graded according to the SAR Score as Mild (score 0-3), Moderate (score4-6) and Severe (score 6-10).
Effectiveness is recorded as 'positive' in case of reduction in SARS score ≤3.
A cut-off of score '3' is taken.
So if the score of 3 or less than 3 is achieved with bCPAP or with nasal oxygen after 48 hours of intervention, the intervention is considered to be effective
|
48 hours since application of intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean reduction in SAR Score
Time Frame: 48 hours
|
Mean reduction in Silverman Anderson Retraction Score, over a period of 48 hours, in both groups
|
48 hours
|
Difference in mean reduction
Time Frame: 48 hours
|
difference between both the groups, will also be calculated.
|
48 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tehreem Fatima, FCPS, King Edward Medical University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BubbleCPAP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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