PRETERM YENİDOĞANLARDA ANNE KOKUSUNUN APNE GELİŞİMİNE, FİZYOLOJİK PARAMETRELERE VE KİLO ALIMINA ETKİSİ
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Frequency of Apnea Episodes
研究概览
简要总结
Apnea of prematurity is one of the most common complications in preterm infants hospitalized in neonatal intensive care units. This randomized controlled trial was conducted to evaluate the effect of maternal odor exposure as a developmental care intervention on apnea frequency, physiological parameters, and growth outcomes in preterm infants. Sixty preterm infants were randomly assigned to either a maternal odor intervention group or a routine care control group. The intervention group received maternal odor using a cotton cloth carrying the mother's natural scent for five consecutive days. The primary outcome was the daily number of apnea episodes. Secondary outcomes included oxygen saturation, heart rate, respiratory rate, body temperature, weight, and head circumference.
详细描述
Apnea of prematurity is a frequent complication of preterm birth and is associated with intermittent hypoxemia and adverse clinical outcomes. Developmental care interventions that provide familiar sensory stimulation may improve physiological stability in preterm infants. Maternal odor is a natural olfactory stimulus that may support autonomic regulation and respiratory stability through early sensory recognition.
This single-center, parallel-group, randomized controlled trial evaluated the effectiveness of maternal odor exposure in preterm infants admitted to the neonatal intensive care unit. Sixty eligible preterm infants were randomly assigned in a 1:1 ratio to either a maternal odor intervention group or a routine care control group. Maternal odor was provided using a cotton cloth impregnated with the mother's natural body odor, positioned approximately 10-15 cm from the infant's head for five consecutive days and replaced every 8 hours.
The primary outcome was the daily frequency of apnea episodes. Secondary outcomes included oxygen saturation (SpO₂), heart rate, respiratory rate, body temperature, weight, and head circumference. Outcomes were compared between groups to determine whether maternal odor exposure improves respiratory stability and physiological regulation in preterm infants.
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
- None
盲法说明
Blinding was not feasible because of the nature of the maternal odor intervention.
入排标准
- 年龄范围
- 5 Days 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants born between 26 and 37 weeks of gestation
- •Birth weight between 1000 and 2500 g
- •Hospitalized in the neonatal intensive care unit for at least 5 days
- •Receiving oral or enteral feeding
- •Written informed consent obtained from parent(s) or legal guardian(s)
排除标准
- •Endotracheal intubation, mechanical ventilation, or nasal continuous positive airway pressure
- •Receiving oxygen therapy
- •Congenital heart disease
- •Suspected or confirmed sepsis
- •Intracranial hemorrhage
- •Receiving analgesic, sedative, or muscle relaxant therapy
- •Previous surgical procedure
- •Development of a medical condition requiring withdrawal from the study or hospitalization for less than 5 days
结局指标
主要结局
Frequency of Apnea Episodes
时间窗: Daily for 5 consecutive days
Number of apnea episodes experienced by preterm infants during the 5-day study period. Apnea episodes were recorded prospectively using the Premature Observation Form.
次要结局
- Heart Rate(Measured four times daily for 5 consecutive days)
- Peripheral Oxygen Saturation(Measured four times daily for 5 consecutive days)
- Respiratory Rate(Measured four times daily for 5 consecutive days)
- Body Temperature(Measured four times daily for 5 consecutive days)
- Weight Gain(Baseline and Day 5)
- Head Circumference Growth(Baseline and Day 5)