Abstract
Background Neonatal Respiratory Distress Syndrome (NRDS) remains a significant challenge in neonatal care, often leading to respiratory compromise and neuromuscular dysfunction. While advances in medical management have improved outcomes, adjunctive therapies such as physical rehabilitation offer potential benefits yet require further investigation. This protocol outlines a randomized controlled trial aiming to evaluate the effect of Physical Rehabilitation using Oro Motor Stimulation, Manual Airway Clearance Technique, Positioning, Tactile, and Kinesthetic Stimulation (PROMPT) protocol on respiratory and neuromuscular function in neonates with NRDS. Methods The trial will include 38 neonates diagnosed with NRDS, randomly allocated into two groups: the intervention group receiving the PROMPT protocol alongside standard care, and the control group receiving standard care alone. The PROMPT protocol comprises a comprehensive approach targeting oromotor stimulation, manual airway clearance technique, optimal positioning, and tactile/kinesthetic stimulation. Outcome measures Primary outcomes will focus on respiratory parameters such as oxygenation index, ventilatory support requirements, and neuromuscular function assessed through muscle tone and reflexes. Secondary outcomes will encompass length of hospital stay, incidence of complications, and neurodevelopmental outcomes at follow-up. Results Data analysis will employ appropriate statistical methods to compare outcomes between the intervention and control groups, with adjustments for potential confounders. Ethical approval has been obtained, and informed consent will be obtained from parents or legal guardians before enrolment. Conclusion This trial protocol aims to provide valuable insights into the efficacy and safety of the PROMPT protocol as a rehabilitative intervention for NRDS. The findings may inform future clinical practice and contribute to optimizing care strategies for neonates with NRDS, ultimately improving their short- and long-term outcomes. Registration CTRI/2024/03/064911