: Effect of Intranasal Breast Milk Administration on Cerebral Oxygenation, Vital Signs and Transition Time to Full Oral Feeding in Preterm Babies: Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Physiologic Parameter Follow-up Form-Oxygen saturation (sPO2)
研究概览
简要总结
The aim of the study was to investigate the effect of intranasal breast milk administration on cerebral oxygenation level, vital signs and time to full oral feeding in preterm infants.
详细描述
Breast milk is rich in pluripotent stem cells, including pluripotent stem cells that produce neuronal cells in vitro. Therefore, intranasal breast milk administration in neonates may potentially allow the transport of stem cells and other molecules into brain tissue through the nasal vasculature and permeable neonatal blood-brain barrier. In recent years, studies on intranasal breast milk administration in newborns have been published. In studies, there is evidence that intranasal breast milk may be effective in reducing cerebral damage after intracranial hemorrhage in preterm newborns and that the application can be tolerated by preterm newborns.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 28 Weeks 至 37 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Birth weight >1000 gr,
- •APGAR score >7 at 5 minutes after birth,
- •Availability of breast milk,
- •No medical diagnosis affecting cerebral oxygenation (intraventricular hemorrhage, cardiovascular and neurological disorders, anemia),
- •No congenital anomalies or chromosomal abnormalities,
- •No congenital anomaly (such as cleft palate) affecting nasal patency.
排除标准
- •Being able to feed orally in all feedings
- •Being fed entirely on formula milk,
- •Administration of medication via the nasal route,
- •Being intubated or receiving continuous positive air pressure (CPAP) support,
- •Maternal substance abuse, alcohol abuse, HIV infection, untreated active tuberculosis, chemotherapy or radiotherapy treatment,
- •The mother has mastitis, breast trauma, abscesses or is taking any medication that passes into the milk,
- •The mother does not want to express milk.
研究组 & 干预措施
Control Group
Preterm newborns in the control group will not receive any intervention.
Intranasal Breast Milk Group
Preterm infants (28-37 gestation week) in the intervention group will receive 0.2 ml of breast milk intranasally three times a day for three days.
干预措施: Intranasal human breast milk (Other)
结局指标
主要结局
Physiologic Parameter Follow-up Form-Oxygen saturation (sPO2)
时间窗: First measurement- 5 minutes before the intervention (T0)
Oxygen saturation (sPO2) in the Physiological Parameter Monitoring Form will be measured 5 minutes before the intervention.
Infant Information Form
时间窗: First measurement-First day of hospitalization
The form developed by the researchers in line with the literature includes the identifying information of the preterm infant (gender, date of birth, gestational week at birth, mode of delivery, APGAR score, birth weight, postmenstrual age)
Physiologic Parameter Follow-up Form-Cerebral rSO2
时间窗: First measurement- 5 minutes before the intervention (T0)
Cerebral rSO2 in the Physiological Parameter Monitoring Form will be measured 5 minutes before the intervention.
Physiologic Parameter Follow-up Form-Heart Rate (HR)
时间窗: First measurement- 5 minutes before the intervention (T0)
Heart rate in the Physiological Parameter Monitoring Form will be measured 5 minutes before the intervention.
Physiologic Parameter Follow-up Form-Respiratory rate
时间窗: First measurement- 5 minutes before the intervention (T0)
Respiratory rate in the Physiological Parameter Monitoring Form will be measured 5 minutes before the intervention.
Nutrition Follow-up Form-intranasal breast milk content
时间窗: First measurement- intranasal breast milk content
Intranasal breast milk content (fresh/thawed) in the Nutrition Follow-up Form will be recorded before the intervention.
次要结局
- Physiologic Parameter Follow-up Form -Cerebral rSO2(Second measurement- 30. minutes after the intervention (T1))
- Physiologic Parameter Follow-up Form -Oxygen saturation (sPO2)(Second measurement- 30. minutes after the intervention (T1))
- Physiologic Parameter Follow-up Form -Heart Rate (HR)(Second measurement- 30. minutes after the intervention (T1))
- Physiologic Parameter Follow-up Form -Respiratory rate(Second measurement- 30. minutes after the intervention (T1))
- Nutrition Follow-up Form-Nutrient content(Second measurement-Nutrient content)
- Nutrition Follow-up Form-Number of vomits(Second measurement- Number of vomits)
- Nutrition Follow-up Form-Number of defecations(Second measurement- Number of defecations)
- Nutrition Follow-up Form-The time of transition to full oral feeding(Second measurement- The time of transition to full oral feeding)
- Nutrition Follow-up Form-Discharge time(Second measurement- Discharge time)
- Physiologic Parameter Follow-up Form -Cerebral rSO2(Second measurement- 5. minutes after the intervention (T1))
- Physiologic Parameter Follow-up Form -Cerebral rSO2(Second measurement- 15. minutes after the intervention (T1))
- Physiologic Parameter Follow-up Form -Oxygen saturation (sPO2)(Second measurement- 5. minutes after the intervention (T1))
- Physiologic Parameter Follow-up Form -Oxygen saturation (sPO2)(Second measurement- 15. minutes after the intervention (T1))
- Physiologic Parameter Follow-up Form -Heart Rate (HR)(Second measurement- 5. minutes after the intervention (T1))
- Physiologic Parameter Follow-up Form -Heart Rate (HR)(Second measurement- 15. minutes after the intervention (T1))
- Physiologic Parameter Follow-up Form -Respiratory rate(Second measurement- 5. minutes after the intervention (T1))
- Physiologic Parameter Follow-up Form -Respiratory rate(Second measurement- 15. minutes after the intervention (T1))