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临床试验/NCT01237015
NCT01237015Unknown不适用

Effect of Nasal Continuous Positive Airway Pressure (CPAP) on Sucking, Swallowing and Coordination of Breathing and Swallowing During Oral Feeding in Human Neonates

Université de Sherbrooke2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2010年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
10
试验地点
2
主要终点
Continuous monitoring of sucking, swallowing, breathing and cardiac parameters

研究概览

简要总结

Current knowledge suggests that, to be successful, oral feeding in preterm babies should be initiated as soon as possible, often at an age where immature respiration still requires ventilatory support in the form of continuous positive airway pressure (CPAP). While some neonatologist teams claim great success with initiation of oral feeding in immature babies with CPAP, others strictly wait for CPAP to be no longer necessary before any attempt at oral feeding. Such controversy is fuelled by ignorance of the effects of CPAP on nutritive sucking and swallowing, including their coordination with breathing, and the fear to induce deleterious problems such as pulmonary aspiration of milk and/or respiratory failure. Ensuing delay in becoming proficient with oral feeding unduly prolongs hospital stays of preterm babies.

The aim of this study is to evaluate the effects of nasal CPAP on oral feeding in human neonates. More specifically, CPAP effects on nutritive sucking and swallowing, including on breathing-swallowing coordination, will be carefully assessed. The investigators hypothesize that nasal CPAP will lead to no or minimal alterations of breathing-nutritive swallowing coordination and will not induce deleterious cardiorespiratory events.

Accordingly, each neonate will be evaluated during 2 bottle feedings spaced of 24 h, one with nasal CPAP 5 cm H2O and the other without any CPAP. Sucking and swallowing activity, respiration, heart rate and oxygenation will be continuously recorded before, during and after bottle-feeding.

By filling a gap in knowledge, results from the study will hopefully help neonatologists afraid of doing more harm than good when initiating bottle-feeding in preterm babies under CPAP to join the many teams for whom it is no more a problem.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Gestational age 24 weeks or more
  • Hospitalized in the neonatology unit or the maternity unit of CHUS Fleurimont
  • Feeds by complete oral feeding since 24 hours or more

排除标准

  • Upper airways anomaly
  • Brain injury : periventricular leukomalacia or intracranial hemorrhage > grade III (Papile classification)
  • Neuromuscular disease
  • Life-threatening congenital disease
  • Any symptomatic intercurrent acute disease (ex.: infection)

结局指标

主要结局

Continuous monitoring of sucking, swallowing, breathing and cardiac parameters

时间窗: 2 days

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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