Clinical trial NCT04401696: Effectiveness of Bubble Nasal Continuous Positive Airway Pressure (bCPAP) in Neonatal Respiratory Distress
Official title: Comparison of Bubble Nasal Continuous Positive Airway Pressure (bCPAP) Versus Control in Neonates With Respiratory Distress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Respiratory Distress
Keywords: bubble CPAP
respiratory distress
neonates
Silverman Anderson Retraction Score
Lead sponsor: King Edward Medical University
Sponsor class: OTHER
First posted: 2020-05-26
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Effectiveness of Bubble CPAP determined by improvement in Silvermann Anderson Retraction Score
timeFrame: 48 hours since application of intervention
Secondary outcomes:
measure: Mean reduction in SAR Score
timeFrame: 48 hours
measure: Difference in mean reduction
timeFrame: 48 hours
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: King Edward Medical University/ Mayo Hospital Lahore
state: Punjab
Study officials:
affiliation: King Edward Medical University
name: Tehreem Fatima, FCPS
role: PRINCIPAL_INVESTIGATOR
References:
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