Evaluation of comparative efficacy of healthcare delivery by mothers versus trained healthcare workers in adjunct to Vojta therapy on clinical outcomes in neonates with respiratory distress syndrome: a protocol for randomised controlled trial

评估由母亲提供医疗保健与由受过培训的医护人员提供医疗保健辅助Vojta疗法对新生儿呼吸窘迫综合征临床结局的疗效比较:一项随机对照试验方案

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Abstract

INTRODUCTION: A common and serious illness that frequently necessitates specific respiratory and developmental assistance is Neonatal Respiratory Distress Syndrome (NRDS), which affects premature infants. A neurophysiological physiotherapy technique called Vojta therapy has demonstrated potential in enhancing neuromotor development and breathing patterns. However, the availability of qualified healthcare professionals frequently limits its administration. This gap might be closed by involving mothers as qualified caretakers, particularly in environments with limited resources. METHODS AND ANALYSIS: Comparing the effects of Vojta therapy administered by trained mothers against trained healthcare professionals on clinical, pulmonary and neurodevelopmental outcomes in neonates with NRDS is the goal of this randomised controlled experiment. Preterm neonates before 36 weeks of gestation who have stable vital signs (pulse rate (PR) 160-180 bpm, respiratory rate (RR) >60 or apnoea), mild to severe NRDS and no mechanical breathing will be included in this randomised controlled experiment. On the Silverman-Anderson Respiratory Severity Score, neonates must have a score between 1 and 7. Standardised training will be provided to mothers and healthcare professionals, and participation in care delivery will only be permitted for those who receive a score of ≥9/10 on a paediatric physiotherapy competency evaluation. Two groups will be formed at random from the participants. Group B will receive the Vojta Approach from a trained healthcare worker, whereas Group A will receive the Vojta Approach in conjunction with maternal participation in healthcare. The Hammersmith Infant Neurological Examination will be used to measure neurodevelopmental status, early feeding skills (as determined by the Early Feeding Skills Assessment Tool), oxygen saturation, PR, RR, Silverman-Anderson Score and length of hospital and neonatal intensive care unit stay. ETHICS AND DISSEMINATION: The study is approved by the Institutional Ethics Committee of Datta Meghe Institute of Higher and Research (DU) under ID: (DMIHER(DU)/IEC/2024/15) and by Clinical Trial Registry-India CTRI/2024/12/078619.

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