Effects on Coordination of Sucking, Swallowing and Breathing Process of a Valved Feeding System in Late-preterm Newborns. The Safe Oral Feeding Trial (SOFT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Evaluating the level of coordination in the sucking-swallowing-breathing pattern in the B-ESP group compared with the B-STD
研究概览
简要总结
Comparing with a randomized controlled trial two different feeding systems in two groups of late-preterm newborns for evaluating which is more efficient in promoting the coordination in the process of sucking-swallowing-breathing and better cardiorespiratory stability.
The B-ESP group will be fed with a feeding system with a valved ergonomic teat; the B-STD with a standard feeding system.
详细描述
The swallowing patterns are still immature in the newborn, especially if preterm. An incomplete synchronization in the process of sucking, swallowing and breathing could lead to some difficulty during feedings with desaturations and risk of milk inhalation in the upper airway tract. Moreover, a dysfunctional or immature pattern of sucking, swallowing and breathing also affect the post-prandial period, tiring the newborn and increasing the cardio-respiratory instability.
Breastfeeding promote the development of a physiological coordination of the process of sucking, swallowing and breathing, guaranteeing high and stable values of oxygenation during feedings. On the other hand, bottle-feeding could be responsible of a difficult coordination among the phases of swallowing and breathing. In an healthy, at term, brestfed newborn is observed a typical pattern of sucking-swallowing-expiration with a ratio of 1:1:1. In a bottlefed newborn this ratio is 2-12:1:4, with a relative increase of the period of sucking compared to the swallowing one, that could lead to apnoeas and desaturations.
The differences between the two feedings modality are more accentuated in the late-preterm newborn, which is more prone to cardio-respiratory instability compared to the healthy at term newborn, because of the immaturity of the respiratory centers in the brainstem, and of the processes responsible for the coordination of the sucking, swallowing and breathing .
However breastfeeding, in spite of the fact that is crucial for the development of the correct process of sucking, can be challenging in the premature infant because it requires a considerable physical effort.
Therefore, disposing of devices for nutrition able to facilitate oral feeding, simulating the physiologic breastfeeding, is necessary. In this way, we can contribute to the development of the proper sucking-swallowing-breathing pattern and to improve cardio-respiratory 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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 5 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age 34+0 - 36+6 weeks at birth;
- •Exclusive oral feeding;
- •Bottle-feeding for at least a meal a day;
排除标准
- •Newborns with exclusive breastfeeding;
- •Newborns with congenital anomalies, perinatal asphyxia, respiratory or neurological issues, genetic syndromes, infections, metabolic diseases;
- •Ongoing administration of medication able to interfere with esophageal or respiratory function;
- •Newborns who require respiratory support, including oxygen-therapy via nasal-cannula;
- •Newborns who require oral or nasal feeding tube;
研究组 & 干预措施
B-ESP
B-ESP group will be fed with a feeding system with a valved ergonomic teat.
干预措施: Valved ergonomic teat (Device)
B-STD
B-STD will be fed with a standard feeding system.
干预措施: Standard silicon teat (Device)
结局指标
主要结局
Evaluating the level of coordination in the sucking-swallowing-breathing pattern in the B-ESP group compared with the B-STD
时间窗: Calculated throughout 72 hours
This evaluation will be recorded at 24 and 72 hours of life and defined from the suckings/swallowings ratio. The literature describes this parameter as strongly associated to a higher maturity of the sucking-swallowing-breathing pattern; in fact, a ratio of sucking-swallowing-breathing of 1:1:1 describes the mature pattern, typical of the breastfeeding and considered the optimum for a newborn.
次要结局
- Coefficient of variation of time between sucking and swallowing(Calculated throughout 72 hours)
- Number of breastfed newborns at the time of dimission(Calculated throughout 72 hours)
- Evaluation of the sucking processes(Calculated throughout 72 hours)
- Mean percentage of incidence of breaths that precede and follow the swallowings(Calculated throughout 72 hours)
- Evaluation of cardiorespiratory stability(Calculated throughout 72 hours)
- Evaluation of meal tolerance(Calculated throughout 72 hours)
研究者
Francesco Cresi, MD, PhD
Principal Investigator
University of Turin, Italy