Incidence and clinical predictors of Continuous Positive Airway Pressure (CPAP) failure among preterm neonates: a prospective clinical research study protocol
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Introduction
Newborn babies frequently encounter acute respiratory failure requiring assisted ventilation. Acute respiratory failure in infants commonly present in a form of respiratory distress syndrome. There are several studies that documented factors associated with CPAP failure rates among preterm newborns worldwide. However, they were either statistically underpowered or defined by overt design errors. The proposed study will estimate incidence rate and predictors of Continuous Positive Airway Pressure (CPAP) failure among preterm newborns delivered at representative hospitals in a typical urban area of Africa.
Methods and analysis
a prospective longitudinal cohort observational, analytical study will be conducted at neonatal and emergency units of all Dar es Salaam public regional referral hospitals from March to (and including) August 2026. Newborns with CPAP failure will be the target population. Newborns without CPAP failure will be the control group. Follow-up for each child will commence from the moment the child is subjected to CPAP until CPAP failure is clinically evident or day seven of life, whichever comes first. Interval assessment of the SAS scores (for CPAP potency) will be done using Silverman-Anderson score sheet in 4-6 hours intervals (unless otherwise dictated by the child’s clinical situation). The main outcome/dependent variable will be proportion of new CPAP failure per newborn-time of follow-up. A multivariable linear model will be used to account for independent predictors of CPAP failure. Unless otherwise stated, an α-level of 5% will be used as a limit of type 1 error in findings.
Ethics and Dissemination process
The study has received an IRB certificate (IRB reference: KU/IREC/27.10/639) from the Institutional Research Ethics Committee of KU. Permission to recruit the affected children has been sought from Municipal’s based hospitals’ directors of Amana, Mwananyamala and Temeke regional referral hospitals respectively. Written informed consent will be sought from mothers of all recruited newborn babies.
Strengths and limitations of this study
The findings of this study will be probably the first original findings to characterize incidence rate and clinical predictors of CPAP failure among newborns according to their birth stata (extreme preterms vs preterms vs terms vs. >week 42 newborns)
The study findings will bring about the incidence rate measure, unlike others in the past that mainly reported their burden using prevalence estimates.
Referral biases may not be adequately controlled by this follow-up study since all our recruits will be from referral hospitals with both NICU and emergency facilities for acute respiratory failure in newborns.
Potentially high attrition (due to say early deaths?) rates among followed-up newborns.
