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临床试验/NCT07306793
NCT07306793招募中不适用

The Effect of Oral Motor Intervention and Chronobiological Approach to Feeding Models Applied to Preterm Infants on Infants' Readiness to Feed, Transition to Total Oral Feeding, and Body Weight

Aydin Adnan Menderes University1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2025年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
54
试验地点
1
主要终点
Readiness for Feeding

研究概览

简要总结

This is a randomized controlled experimental study evaluating the effects of oral motor intervention and chronobiological approach to feeding model applied to preterm infants on feeding readiness, transition to total oral feeding and body weight.

详细描述

Premature birth is defined as birth occurring before the 37th week of gestation, and approximately 15 million babies are born this way worldwide each year. Premature babies experience feeding difficulties because their oral feeding skills, sucking-swallowing-breathing coordination, and oral structures are not fully developed. Their oral motor systems typically mature between 32-34 weeks of gestation. The development of the oral motor system is crucial for adequate nutrition, growth, and weight gain. Several methods are used to improve the oral motor development of premature babies. Oral motor interventions involve physical stimuli applied to intraoral structures such as the lips, tongue, cheeks, gums, and palate. These methods aim to increase the functional strength of oral muscles and target neuro-behavioral synergy.

Oral motor interventions applied in NICUs have been shown to accelerate the transition to oral feeding, increase weight gain, and shorten hospital stays in premature infants. Premature Infant Oral Motor Intervention (PIOMI) is one of the interventions applied in NICUs. Studies have shown that PIOMI is more effective than other interventions in this field. Furthermore, no negative side effects of PIOMI have been reported.

Breast milk is an ideal source of nutrition for the growth and development of preterm infants. It provides essential nutrients for the baby's growth and development, as well as containing biological cues that help regulate circadian rhythms. For the fetus, which has become accustomed to the mother's circadian rhythms during intrauterine life, it supports this transition process by providing similar cues after birth. The composition of breast milk can vary depending on gestational age, lactation stage, and pumping time. Differences are particularly observed between day and night breast milk in terms of circadian rhythms. Daytime milk contains higher levels of substances such as immune system-related nucleotides, interleukins, and antioxidants, while nighttime milk is rich in sleep-regulating components such as melatonin and tryptophan. This difference is important for the transmission of the mother's biological rhythms to the baby, contributing to the regulation of the baby's sleep-wake cycle and improving its environmental adaptation.

The chronobiological feeding model suggests that expressed breast milk be given in periods of day and night, or more specifically, in six-hour cycles, in accordance with the daily cycle. This approach aims to support the development of the infant's circadian rhythm through expressed breast milk in situations where breastfeeding is not possible. A review of the literature revealed no studies that combined PIOMI with chronobiological feeding. Therefore, this research was planned to determine the effects of oral motor intervention (PIOMI) and chronobiological feeding on feeding readiness, transition to total oral feeding and body weight in preterm infants hospitalized in the NICU.

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
None

入排标准

年龄范围
29 Weeks 至 33 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Preterm infants with a postnatal age of 29-33 weeks,
  • Whose vital signs and clinical condition have been stable for at least 24 hours,
  • Whose APGAR score at 1 and 5 minutes (Activity-Pulse-Grimace-Appearance-Respiration) is 4 or higher.

排除标准

  • Infants with major congenital anomalies (such as congenital heart disease, cleft palate, cleft lip) or birth trauma,
  • Infants with RDS,
  • Infants diagnosed with asphyxia,
  • Infants with intraventricular hemorrhage,
  • Infants with Neonatal Withdrawal Syndrome,
  • Infants with Fetal Alcohol Syndrome,
  • Infants included in the study group who develop any complications or whose stable condition deteriorates during the follow-up period,
  • Infants with feeding intolerance or who are interrupted from feeding for more than 48 hours,
  • Infants who develop sepsis,
  • Infants who develop necrotizing enterocolitis,
  • Infants receiving mechanical ventilation support,
  • Infants who receive narcotic analgesia or sedation,

研究组 & 干预措施

PIOMI study group

Experimental

Premature infant group undergoing Oral Motor Intervention.

干预措施: PIOMI study group (Other)

Nutrition Study Group with a Chronobiological Approach

Experimental

Group of infants fed using chronobiological approaches

干预措施: Nutrition Study Group with a Chronobiological Approach (Other)

No Intervention

Other

Control group.

干预措施: Control group (Other)

结局指标

主要结局

Readiness for Feeding

时间窗: Newborns At 29-33 Gestatıonal Weeks

On days 1, 8, 11, and 14 of the study, the readiness of the infants for oral feeding will be assessed using the Premature Infant Readiness for Oral Feeding Assessment Scale. The Turkish validity and reliability of this scale, developed by Çamur and Çetinkaya, shows a cutoff point of 29. The maximum possible score on the scale is 36. A higher score indicates better readiness.

Transitioning to Total Oral Feeding

时间窗: Newborns at 29-33 Gestatıonal Weeks

Infants' nutritional information will be assessed daily using an infant monitoring form.

Body Weight

时间窗: Newborns at 29-33 Gestatıonal Weeks

Infants' body weights will be measured on days 1, 8, 11, and 14, on the day they start total oral feeding, and on the day they are discharged, at 8:30 AM, wearing only a clean diaper.

次要结局

未报告次要终点

研究者

发起方
Aydin Adnan Menderes University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Esra Bozkurt

MSc

Aydin Adnan Menderes University

研究点 (1)

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