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

Study Overview
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Brief Summary
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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.

Detailed Description
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After approval from the IRB of King Edward Medical University, and taking informed consent from parents of the participants, total of 120 neonates fulfilling inclusion and exclusion criteria will be enrolled and randomly allocated in two groups; group A and group B. All demographic details of participants in both groups be collected. In group A, neonates will be given bCPAP for respiratory support while neonates in group B, will be given nasal oxygen as control group. Neonates in both groups will be followed for 48 hours. The effectiveness will be determined by the reduction in Silverman Anderson Retraction Score (SARS) up to or less than 3, at the end of 48 hours. Data will be collected and analysed.

Official Title
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Comparison of Bubble Nasal Continuous Positive Airway Pressure (bCPAP) Versus Control in Neonates With Respiratory Distress

Conditions
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Neonatal Respiratory Distress

Intervention / Treatment
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* Device: Bubble CPAP
* Other: Nasal Oxygen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Hour
Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Use of Bubble CPAP for management of respiratory distress | Device: Bubble CPAP<br>* 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.<br>|
| Active Comparator: Group B<br>Use of Oxygen via nasal cannula for respiratory distress | Other: Nasal Oxygen<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean reduction in SAR Score | Mean reduction in Silverman Anderson Retraction Score, over a period of 48 hours, in both groups | 48 hours | 
| Difference in mean reduction | difference between both the groups, will also be calculated. | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bubble CPAP, respiratory distress, neonates, Silverman Anderson Retraction Score