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临床试验/NCT03513146
NCT03513146已完成不适用

Impact of Oropharyngeal Administration of Mother's Milk Prior to Gavage Feeding on Hospital Acquired Neonatal Infection

Mansoura University Children Hospital2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年5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
200
试验地点
2
主要终点
Hospital Acquired late onset neonatal sepsis

研究概览

简要总结

The protective effect of mother's milk and colostrum on oropharyngeal cavity is not achievable with gavage feeding. This may be increase the risk of colonization of the oropharyngeal cavity with pathogenic bacteria and subsequent increase in the risk of neonatal sepsis. We aim to study the impact of Oropharyngeal Administration of Mother's Milk (OPAMM) before gavage feeding on clinical outcome, bacterial colonization of the GIT of preterm infants with pathogenic bacteria. We also aim to study the immune-protective effect of OPAMM on the incidence of nosocomial sepsis.

详细描述

Preterm, very low Birth Weight (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 an inflammatory cascade, edema of the bowel, and subsequent development of necrotizing enterocolitis (NEC).

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

The gut of preterm infants is frequently colonized with pathogenic bacteria due to prematurity, increase gut mucosal permeability, delayed initiation of feeding, formula feeding, and frequent use of antibiotics. This pathogenic bacteria increase the chance of development of nosocomial acquired sepsis and NEC.

Mother's milk, particularly colostrum, is rich in cytokines and other immune agents that provide bacteriostatic, bacteriocidal, antiviral, anti-inflammatory and immunomodulatory protective agents against infection. Thus early gut priming and initiation of enteral feeding of preterm infants with mother's colostrum and milk decrease pathogenic bacterial colonization and subsequent development of sepsis and NEC.

During breast feeding, mother's milk comes in contact with the mouth and oro-pharyngeal pouch which, theoretically, stimulate both oropharyngeal 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 oropharyngeal as well as GIT mucosa.

研究设计

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

盲法说明

Microbiological assessment of bacterial colonization of the oropharyngeal cavity and the GIT will be masked

入排标准

年龄范围
1 Day 至 90 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 mothers' 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

Hospital Acquired late onset neonatal sepsis

时间窗: Neonatal care unit admission

Culture proven neonatal sepsis acquired during neonatal care admission

次要结局

  • Colonization of the oro-pharyngeal pouch with pathogenic micro-organism(Neonatal care unit admission)
  • Colonization of the GIT with pathogenic micro-organism(Neonatal care unit admission)
  • Necrotizing enterocolitis(Neonatal care unit admission)
  • Ventilator associated pneumonia(Neonatal care unit admission)

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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