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临床试验/NCT02027688
NCT02027688已完成不适用

Feeding Progression in Preterm Infants

University of Pennsylvania4 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2014年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
55
试验地点
4
主要终点
Time to full oral feeds

研究概览

简要总结

Preterm infants face many feeding challenges during hospitalization which can prolong hospitalization, raise parental anxiety and can lead to medical instability. The Feeding Progression study will randomize preterm infants to one of two currently accepted oral feeding schedules; oral feed attempts every 3 hours or every 6 hours. The study will collect data on oral feeding success, milk transfer, sucking strength, growth and medical complications.

详细描述

Preterm infants are at high risk for feeding issues. Feeding difficulties lead to prolonged hospitalization, increase medical complications and raise parental anxiety. The transition from tube feeding to oral feeding is an especially important step in a preterm infant's early life. Currently, there is limited evidence to guide this transition. There are two commonly used schedules for transitioning preterm infants to oral feeding: an every 6 hour schedule and an every 3 hour schedule. However, there is currently no evidence to guide providers in their choice of oral feeding schedule.

The primary objective of this study is to explore whether an every 6 (q6) hour oral feeding schedule will improve time to full oral feedings as compared to an every 3 (q3) hour oral feeding schedule. The secondary objectives are to test whether every 6 hour feeding allows for improved medical stability and oral-motor coordination as compared to the other commonly used q3 hour schedule. Each infant will be randomly assigned to a q6 hour or q3 hour oral feeding schedule. Data on oral feeding progression, respiratory status and oral motor proficiency will be collected and compared. The study will collect data on how long it takes each infant to get to full oral feeds, respiratory status throughout their time of oral feeding, whether there were any episodes of medical complications, measures of oral motor feeding skills, and the time to discharge from the hospital. This study is a crucial first step towards determining which feeding schedule is optimal for preterm infants to ensure timely attainment of full oral feeds and hospital discharge without compromising medical stability.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
— 至 120 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Gestational age between 23 0/7-33 0/7 weeks
  • Eligible for oral (PO) feeding as determined by the attending Neonatologist

排除标准

  • Infants with major congenital malformations
  • Infants with chromosomal defects
  • Diagnosis of Neonatal Abstinence Syndrome or opiate withdrawal
  • Grade 3 or 4 Intraventricular Hemorrhage

结局指标

主要结局

Time to full oral feeds

时间窗: 38 weeks gestation on average

Assess the relationship between feeding schedule and time to reach full oral feeds in preterm infants.

次要结局

  • Time to discharge(40 weeks gestation on average)
  • Medical Complications(38 weeks gestation on average)
  • Growth(40 weeks gestation on average)
  • Feeding skills(40 weeks gestation on average)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sara DeMauro

MD, MSCE

University of Pennsylvania

研究点 (4)

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