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临床试验/CTRI/2025/07/092126
CTRI/2025/07/092126尚未招募不适用

Efficacy of Oromotor Stimulation and Non Nutritive Sucking vs Non Nutritive Sucking alone on Transition from Gavage to Full Oral Feeding in Preterm Neonates: A Randomized controlled trial

Ritika Agrawal1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年9月1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
70
试验地点
1
主要终点
To compare the efficacy of Oromotor Stimulation and Non Nutritive Sucking with Non Nutritive Sucking alone with respect to number of days taken for transition from gavage feeding to full oral feeding in Preterm Neonates.

研究概览

简要总结

Fifteen million preterm babies are born each year, and because of their weak oral muscles and uncoordinated sucking and swallowing reflexes, they are at a significant risk of developing feeding problems orally.

Non-nutritive sucking (NNS) is used in preterm newborns to improve the development of sucking behavior and enhance their ability to digest enteral feedings. It is also utilized during gavage feeding and during the transition from gavage to breast or bottle feeding.

A randomized clinical trial had previously investigated the impact of oral motor therapy on non-nutritive sucking (NNS), oral stimulation (OS), and the combination NNS/OS intervention.  The results showed that NNS alone increased sucking pressure during oral feeding and shortened the transition time from gavage feeding to complete oral feeding.

In preterm neonates oromotor stimulation along with routine care reduces the duration of gavage feeding as compared to routine care alone.

Oral motor intervention combined with non-nutritive sucking can significantly improve the oral motor ability of premature newborns, promote the process of oral feeding, improve the outcome of oral feeding, and reduce the occurrence of adverse effects.

The preterm infants who received oral motor stimulation transited to full oral feeding earlier and showed a higher success in sucking.

Some studies shows that the OMS with NNS is showing significant outcomes as compared to NNS alone. On the other hand, in literature review inconsistent data were reported regarding the impact of NNS with OS on functional swallowing outcomes, including a negative effect on weight gain.

Therefore, the aim of the present study was to explore the clinical effectiveness of oral motor intervention combined with NNS on premature infants in comparison with NNS alone.

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
0.00 Day(s) 至 90.00 Day(s)(—)
性别
All

入选标准

  • Preterm Neonates admitted in NICU.
  • Preterm Neonates having stable vital signs and have been started with total gavage feeding.

排除标准

  • Preterm Neonates who are haemodynamically unstable Preterm Neonates having facial oral congenital anomaly.
  • Preterm Neonates without their mothers.

结局指标

主要结局

To compare the efficacy of Oromotor Stimulation and Non Nutritive Sucking with Non Nutritive Sucking alone with respect to number of days taken for transition from gavage feeding to full oral feeding in Preterm Neonates.

时间窗: Time of delivery will be taken as day 1 and duration in days of transition from gavage to full oral feeding will be taken into consideration

次要结局

  • To compare the efficacy of Oromotor Stimulation and Non Nutritive Sucking with Non Nutritive Sucking alone with respect to weight gain in Preterm Neonates(Time of delivery will be taken as day 1 and the neonate will be weighed daily till the transition from gavage to full oral feeding)

研究者

发起方
Ritika Agrawal
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Ritika Agrawal

N. K. P. Salve Institute Of Medical Sciences and Research Centre And Lata Mangeshkar Hospital

研究点 (1)

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