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临床试验/CTRI/2024/03/063666
CTRI/2024/03/063666尚未招募3 期

Role of Premature Infant Oro Motor Intervention to achieve better breast feeding behavior in preterm less than 32 weeks -a randomised control trial

Saveetha Medical College Hospital1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2024年3月15日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
52
试验地点
1
主要终点
To study breastfeeding behaviour after intervention using PIBBS (PRETERM INFANT BREASTFEEDING BEHAVIOR SCALE) scale

研究概览

简要总结

PIOMI wil be given for preterm babies 48 hrs after they are hemodynamically stable. PIOMI will be given for 26 babies for 14 days. In 26 babies in control group  no intervention will be given. After 14 days in each group, breast feeding behavior will be assessed by PIBBS (Preterm Infant Breastfeeding behavior scale) scale. Both the group will be compared for the effectiveness of breastfeeding using the PIBBS scale.

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
0.00 Day(s) 至 2.00 Month(s)(—)
性别
All

入选标准

  • Preterm 29-32 weeks , 48 hrs after hemodynamic stability.

排除标准

  • Congenital malformations including cleft lip and cleft palate
  • Chromosomal anomalies
  • Requires subsequent mechanical ventilation
  • Intraventricular haemorrhage.

结局指标

主要结局

To study breastfeeding behaviour after intervention using PIBBS (PRETERM INFANT BREASTFEEDING BEHAVIOR SCALE) scale

时间窗: To study breastfeeding behaviour after intervention using PIBBS (PRETERM INFANT BREASTFEEDING BEHAVIOR SCALE) scale. after 14days of intervention or no treatment (in control group)i.e on day 15, 16,17 of recruitment. average of the 3 PIBBS score will be taken

次要结局

  • To evaluate the length of hospital stay(time taken to reach 2000gm of weight for discharge)

研究者

发起方
Saveetha Medical College Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Anand kumar G

saveetha medical college hospital

研究点 (1)

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