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临床试验/NCT03552510
NCT03552510已完成不适用

Impact of Oro-Pharyngeal Administration of Mother's Milk Prior to Gavage Feeding on GIT Motility in Preterm Infants

Mansoura University Children Hospital2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
Cholecystokinin

研究概览

简要总结

Mother's milk does not come in contact with the oropharyngeal pouch of preterm infants during gavage feeding. We hypothesized that stimulation of the oropharyngeal pouch using small amount of the mother's milk 5 minutes before initiation of regular gavage feeding will increase the level of GIT hormones.

详细描述

Feeding preterm infants continues to challenge health care providers because of difficulty to provide adequate volume of milk that maintains optimum nutrition without increasing the risk of feeding intolerance. Preterm, VLBW, infants are at increased risk of feeding intolerance as they have shorter GIT with lower digestive, absorptive, and motility capabilities than those of full-term infants. Intolerance to enteral feeding has been associated with abdominal distention, initiation of inflammatory cascade, edema of the bowel, and subsequent development of necrotizing enterocolitis.

Oral feeding is the best physiologic method for enteral nutrition of preterm infants. However, because of immaturity of suckling reflex and poor coordination between suckling and swallowing, gavage feeding (oro-gastric or naso-gastric tube feeding) has been used an alternative method of enteral nutrition in preterm infants.

During breastfeeding, mother's milk comes in contact with mouth and oro-pharyngeal pouch which, theoretically, stimulates both oro-pharyngeal receptors that improves the motility, secretory, and absorptive ability of the GIT. Furthermore, anti-inflammatory and pro-inflammatory cytokines, which are present abundantly in mother's colostrum and milk, may exert an immuno-protective effect when they come in contact with oro-pharyngeal as well as GIT mucosa.

Preterm, VLBW, infant in the NICU receives enteral feedings by a naso-gastric or oro-gastric gavage tube. Thus, mother's milk does not typically come into contact with oro-pharyngeal pouch which delays the maturation of oral suckling and swallowing skills in preterm infants.

Oral stimulation has been shown to improve oral feeding performance, attain early oral feeding, improve weight gain and shorten the length of hospital stay. Investigators aimed to study the effect of Oro-pharyngeal administration of mother's milk before regular gavage feeding on gastrointestinal movement in preterm infants.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

Laboratory assessment of GIT hormonal level will be masked

入排标准

年龄范围
1 Day 至 60 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Preterm infants delivered at less than 32 weeks gestation and less than 1500 grams birth weight will be included in the study

排除标准

  • Preterm infants > 32 weeks gestation unable to be fed on own mother's colostrum or milk.
  • Preterm infants with major congenital anomalies or chromosomal abnormalities.
  • Preterm infants delivered to mothers with confirmed chorioamnionitis.
  • Preterm infants with confirmed early onset sepsis.

结局指标

主要结局

Cholecystokinin

时间窗: 24 hours

Plasma Cholecystokinin hormone level

Motilin hormone

时间窗: 24 hours

Plasma Motilin hormone level

Secretin hormone

时间窗: 24 hours

Plasma Secretin hormone level

Gastrin hormone

时间窗: 24 hours

Plasma Gastrin hormone level

次要结局

  • Holding feeds(24 hours)
  • Feeding residual(24 hours)

研究者

发起方
Mansoura University Children Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nehad Nasef

Professor of Pediatrics

Mansoura University Children Hospital

研究点 (2)

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