Effect of Oropharyngeal Colostrum Administration on Early Feeding Skills in Premature Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Early Feeding Skills Assessment
研究概览
简要总结
this study aimed to determine the effect of oropharyngeal colostrum administration on premature newborns on early feeding cues and transition time to full oral feeding.
详细描述
Breastfeeding has immunologic, nutritional, and neurodevelopmental benefits for premature infants. Follow-up of premature infants in the Neonatal Intensive Care Unit (NICU) for observation and treatment due to immature gestational age, organ or system diseases, and inadequate oral sucking power cause physical and psychological separation of mother and infant, and this is an essential factor leading to breastfeeding failure. Despite the abundant evidence in the literature for the benefits of breast milk and especially colostrum for premature infants, breastfeeding and lactation rates are still very low in this vulnerable population due to poor sucking/swallowing/respiratory coordination.
Although the development of oral feeding skills in premature infants is a challenge for health professionals and parents, oral feeding skills are one of the critical indicators for the discharge of premature infants. Although motor activities such as sucking, swallowing, and breathing are known to be present in the prenatal period, it is not known precisely when this coordination is achieved at the earliest after birth. Approximately 40% of premature infants have difficulty transitioning from enteral to oral feeding. A systematic review showed that premature infants experience problems with oral feeding in the first four years of life, with a prevalence of 42%. Physiological intervention methods that support the transition of premature infants to oral feeding include non-nutritive sucking, oral-motor stimulation, and oral care with colostrum or breast milk. Oropharyngeal colostrum administration is an intervention method reported to activate the digestive hormones of minimal enteral feeding, encourage feeding, accelerate the maturation of the gastrointestinal system, and shorten the transition to full oral feeding with positive stimulation. When the literature is examined, it is reported that premature infants fed with colostrum from the NICU also have increased breastfeeding continuity after discharge. The most crucial difference between our study and the studies available in the literature is related to how oropharyngeal administered colostrum affects the infant's early feeding cues (coordination of sucking-swallowing and respiration during feeding) and how much it accelerates/shortens the transition to oral feeding. In the literature, no study is similar to our study examining how oropharyngeal colostrum administration affects this process in the transition to full oral feeding using a measurement tool on the subject.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 26 Weeks 至 33 Weeks(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The gestational week at the time of delivery is between 260-33+6 gestational weeks, determined according to the mother's last menstrual date and obstetric evaluation results.
- •Started feeding with an orogastric catheter, in the process of transition from catheter feeding to oral feeding
- •Meeting early feeding readiness criteria (stable respiration and oxygen saturation during feeding, responsiveness to perioral/oral stimulation and licking, etc.)
- •750 g or more during the study
- •Stable vital signs (respiratory rate <60/min, heart rate 140-185 beats/min, axillary temperature 36.5-37.4°C) (Acunaş et al., 2018)
- •NICU admission ≤ 24 hours of life; protocol can be started within 72 hours,
- •No muscle relaxants, sedatives, or severe neurological disease
- •Allowing parents of premature infants
排除标准
- •Congenital or chromosomal anomalies, lack of cardiorespiratory stabilization, birth asphyxia (cord ph/arterial ph <
- •, twin or more multiple births, intrauterine growth retardation, necrotizing enterocolitis, pneumothorax, skull fracture, severe atelectasis, circulatory disorder, severe sepsis, having a chest tube, having a history of pathologic jaundice, having a history of antenatal gastrointestinal system disease, born with cleft palate/lip, born to mothers with confirmed chorioamnionitis were excluded.
结局指标
主要结局
Early Feeding Skills Assessment
时间窗: 10 days
Evaluation will begin with oral colostrum administration to premature infants. The tool allows the assessment of preterm infants' readiness for oral feeding and oral feeding skills, the observation of symptoms associated with problem feeding, and the planning of feeding interventions targeting areas where the infant has difficulty or needs support during the transition to oral feeding. Both the revised EFS and the Turkish version of the EFS include 19 items in 5 subscales. These subscales are respiratory regulation, oral-motor function, swallowing coordination, feeding participation, and physiological stability.
次要结局
- Full oral feeding time(20 days)
- Weight gain(10 days)
研究者
Sinem Yalnızoglu Caka
Assoc. Prof.
Kocaeli University
