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

King Edward Medical University

Status: Completed

Conditions: Neonatal Respiratory Distress

Treatments: Device: Bubble CPAP; Other: Nasal Oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT04401696

BubbleCPAP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 1 hour to 28 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Group A

Experimental group

Description:

Use of Bubble CPAP for management of respiratory distress

Treatment:

Device: Bubble CPAP

Group B

Active Comparator group

Description:

Use of Oxygen via nasal cannula for respiratory distress

Treatment:

Other: Nasal Oxygen