Effects of Prefeeding Oral Stimulation on Feeding Performance in Preterm Infants Born Between 26 and 33+6 Weeks' Gestational Age: a Case-control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- Length of Transition Period
研究概览
简要总结
The objective of this study is to evaluate the efficacy of an oral stimulation program on the length of the transition period in preterm infants (primary outcome), the length of hospital stay and the breastfeeding rates at discharge (secondary outcomes).
详细描述
Oral feeding issues in preterm infants are a growing concern for neonatologists because the difficulties preterm infants show in transitioning from tube to independent oral feeding lead to delayed hospital discharge, maternal stress and rising financial burden.
Safety in infant oral feeding implies minimal risk of aspiration and requires the adequate coordination of sucking, swallowing and respiration.
Sucking and swallowing are present in early foetal life, but the coordination of sucking with swallowing and breathing is not thought to occur before 34 weeks post-menstrual age (PMA). Thus, preterm infants tend to suck, swallow and breathe in an alternate, rather than coordinated fashion.
Accelerated maturation of sucking reflex and earlier readiness for bottle-feeding is reported when preterm neonates were given non-nutritive sucking (NNS) opportunities during gavage feeding. Recent evidence suggests that the sensory consequences associated with the production of NNS have beneficial effects on oral feeding performance and the development of specific sucking skills.
At present, it is customary for infants who have stable cardiopulmonary status to be introduced to oral feeding around 33 to 34 weeks PMA. They usually take days or weeks in the transition period of combined gavage and oral feeding before reaching full oral feeding.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •preterm infants from 26 to 33+6 weeks' gestational age, as determined by date of last menstruation and first-trimester ultrasound, hospitalized in our neonatal unit.
排除标准
- •Congenital malformations (chromosomal disorders, malformations of head and face, neurological, cardiac, digestive or pulmonary malformations)
- •Severe asphyxia (hypoxic-ischemic encephalopathy)
- •Presence of third or fourth degree intracranial haemorrhage
- •Severe periventricular leukomalacia
- •Severe chronic lung disease
- •Severe hospital infection during the study period
- •Necrotising enterocolitis during the study period
- •Feeding interruption for more than 10 days during the study period
- •Death during the study period
- •Transfer to another hospital before discharge.
结局指标
主要结局
Length of Transition Period
时间窗: participants were followed from date of randomization until full enteral feeding was acquired,an expected average of 5 weeks
transition period was defined as the period from the introduction of enteral feeding to full enteral feeding
次要结局
- Length of Hospital Stay(participants were followed for the duration of hospital stay, an expected average of 5 weeks)
- Breastfeeding Rate at Discharge(hospital discharge, an expected average of 5 weeks from the beginning of oral feeding introduction)
研究者
Dr Manon BACHE
Paediatrician
Centre Hospitalier du Luxembourg