Effectiveness of Bubble Nasal Continuous Positive Airway Pressure (bCPAP) in Neonatal Respiratory Distress

NCT04401696 | Completed

• 1 other identifier: BubbleCPAP
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of study is to determine the effectiveness of bubble Continuous Positive Airway Pressure (bCPAP) in neonates presenting with respiratory distress as compared to the control group ( using oxygen via nasal cannula). The effectiveness will be calculated in terms of reduction in Silverman Anderson Retraction Score.

Conditions

Neonatal Respiratory Distress

Keywords

bubble CPAP; respiratory distress; neonates; Silverman Anderson Retraction Score

Outcome Measures

Primary Outcomes (1)

• Effectiveness of Bubble CPAP determined by improvement in Silvermann Anderson Retraction Score

  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

Secondary Outcomes (2)

• Mean reduction in SAR Score

  48 hours

• Difference in mean reduction

  48 hours

Study Arms (2)

Group A

EXPERIMENTAL

Use of Bubble CPAP for management of respiratory distress

Device: Bubble CPAP

Group B

ACTIVE COMPARATOR

Use of Oxygen via nasal cannula for respiratory distress

Other: Nasal Oxygen

Interventions

Bubble CPAP DEVICE

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 A

Nasal Oxygen OTHER

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.

Group B

Eligibility Criteria

• Age: 1 Hour - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King Edward Medical University: lead

Study Sites (1)

King Edward Medical University/ Mayo Hospital Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (12)

• 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.

  PMID: 25421903 BACKGROUND

• 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.

  PMID: 25390060 BACKGROUND

• 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.

  PMID: 24760748 BACKGROUND

• 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.

  PMID: 24489715 BACKGROUND

• 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.

  PMID: 23372661 BACKGROUND

• 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.

  PMID: 26348753 BACKGROUND

• 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.

  PMID: 25877290 BACKGROUND

• Kaur C, Sema A, Beri RS, Puliyel JM. A simple circuit to deliver bubbling CPAP. Indian Pediatr. 2008 Apr;45(4):312-4.

  PMID: 18451452 BACKGROUND

• 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.

  PMID: 30632326 BACKGROUND

• 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.

  PMID: 29426853 BACKGROUND

• 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.

  PMID: 28495265 BACKGROUND

• 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.

  PMID: 30636889 BACKGROUND

MeSH Terms

Conditions

Pulmonary Atelectasis; Dyspnea

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tehreem Fatima, FCPS

  King Edward Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tehreem Fatima, Senior Registrar, Children Hospital & ICH Faisalabad.

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: May 26, 2020
• Study Start: April 1, 2017
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: May 26, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)