NCT04401696

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: King Edward Medical University · Academic / Other
• Sex: All
• Age: 1 Hour – 28 Days
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Neonatal Respiratory Distress

Interventions

Type	Name	Description
DEVICE	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.
OTHER	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.

Timeline

• Start date: 2017-04-01
• Primary completion: 2018-06-30
• Completion: 2018-06-30
• First posted: 2020-05-26
• Last updated: 2020-05-26

Locations

1 site across 1 country: Pakistan