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临床试验/CTRI/2024/05/066856
CTRI/2024/05/066856尚未招募不适用

Effect of Multi-stimulation on time taken for transition to full oral feeding (Spoon/ Paladai)in preterm infants: One year hospital based Randomized Control trial.

Jawaharlal Nehru Medical College, KLE University, Belagavi1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2024年5月13日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
98
试验地点
1
主要终点
1. Transition time to full oral feeds (Spoon/ Paladai feeds).

研究概览

简要总结

Feeding problems are the major issues in preterm infants. They have problems in coordinating sucking, swallowing and breathing which are essential components of successful feeding.

Feeding issues are also related to gut immaturity, and neuromuscular incoordination leading to poor tolerance of enteral feeding. Feeding tolerance results in prolonged hospitalisation, increased risk of sepsis and predisposition to serious complications.

Stimulation is the best key to success in acheiving oral feeding perfomance and sustaining breastfeeding.

There are several interventions which help in reducing feeding intolerance and the time taken to acheive full oral feeding in preterm babies and enhance the nutritional and physiological status.

Oromotor stimulation with non nutritive sucking and tactile stimulation improves the neuromotor development , emotional bonding , better sleep wake patterns, and increases the oral feeding skills.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
1.00 Day(s) 至 2.00 Day(s)(—)
性别
All

入选标准

  • 1.Inborn babies between 30 to 34 weeks of gestation 2.Medically stable with minimal respiratory support ( CPAP with FiO2 less than equal to 40 and PEEP less than equal to 5 cm for 24 to 48 hours.
  • Parents willing to participate in the study.

排除标准

  • 1.Major Congenital Anomalies ( Craniofacial malformation, Congenital diaphragmatic hernia , Intestinal obstruction and others)
  • Grade 3 and 4 Intraventricular hemorrhage
  • Necrotizing enterocolitis stage 2 and 3
  • Perinatal asphyxia with HIE stage 2 and 3 Any other condition where intervention cannot be delivered.

结局指标

主要结局

1. Transition time to full oral feeds (Spoon/ Paladai feeds).

时间窗: The infants will be monitored from the date of admission till the date of discharge.

次要结局

  • 1. Weekly weight gain(2. Length of hospital stay)

研究者

发起方
Jawaharlal Nehru Medical College, KLE University, Belagavi
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr. Somayajula Venkata Sri Lalitha Priyanka

Jawaharlal Nehru Medical College, KLE Universiity

研究点 (1)

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