Impact of a combined Oromotor and Tactile Intervention program for Improving Weight Gain, Feeding Tolerance, and Respiratory Function in Preterm Neonates with Respiratory Distress in the Special New born Care Unit: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- weight gain
研究概览
简要总结
Background: Preterm birth is a major global health concern, often complicated by respiratory distress and feeding difficulties due to immature coordination of sucking, swallowing, and breathing. These challenges contribute to poor weight gain, feeding intolerance, and prolonged hospitalization. Oromotor and tactile stimulation have individually shown benefits, but evidence on their combined effects in preterm neonates with respiratory distress remains limited. Aim: To evaluate the impact of a combined oromotor and tactile stimulation program on weight gain, feeding tolerance, and respiratory function in preterm neonates with respiratory distress admitted to a Special Newborn Care Unit (SNCU). Methods: A randomized controlled trial was conducted on 40 preterm neonates (20 intervention, 20 control) admitted to the SNCU, Rajiv Gandhi Government Women and Child Hospital, Puducherry. The intervention group received combined oromotor and tactile stimulation twice daily for up to four weeks in addition to standard care, while the control group received standard physiotherapy and nursing care. Outcomes were assessed using daily weight measurements, Infant Breastfeeding Assessment Tool (IBFAT) scores, and Downes scores for respiratory distress at baseline, week 2, and week 4.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 1.00 Day(s) 至 28.00 Day(s)（—）
- 性别
- All
入选标准
- •Admitted to the Special Newborn Care Unit (SNCU) with respiratory distress Demonstrating clinical signs of dysfunctional sucking, swallowing, and breathing coordination during feeding attempts, irrespective of their gestational age at birth.
- •Have parents or legal guardians who provide written informed consent to participate in the study.
排除标准
- •Neonates will be excluded from the study if they present with any significant comorbidities or clinical instability that, in the judgment of the attending neonatologist and the principal investigator, would interfere with their participation in the study procedures, confound the study outcomes, or pose an increased risk.
结局指标
主要结局
weight gain
时间窗: Weight gain will be measured daily at a fixed time using calibrated | electronic scales, following a standardized protocol.Assessment by trained assessors at predefined time points baseline, 2 | weeks and 4 weeks.
次要结局
- Infant Breastfeeding Assessment Tool(1st week (baseline))
- Downes score(1st week (baseline))
研究者
Yosuva k
Mother theresa Post graduate and Research Institute of Health sciences