The Effect of Caffeine Therapy in Cardiovascular Stability in Preterm Neonates: a Prospective Study at the Neonatal Intensive Care Unit of Assiut University Children Hospital
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Change in mean arterial blood pressure after caffeine therapy in preterm neonates.
研究概览
简要总结
Preterm neonates younger than 37 weeks gestational age receiving caffeine therapy for apnea of prematurity in a NICU setting.
详细描述
The study population consists of 40 preterm neonates admitted to the Neonatal Intensive Care Unit at Assiut University Children Hospital. Inclusion criteria restrict participants to those with a gestational age below 37 weeks who are prescribed caffeine citrate therapy to manage apnea of prematurity. Neonates with major congenital anomalies or those requiring vasopressors at baseline are excluded. The cohort is monitored closely for cardiovascular parameters and adverse reactions related to caffeine administration. Demographic and clinical baseline data include prenatal risk factors, gestational and postnatal age, and birth weight. This focused population allows investigation of caffeine's impact on vulnerable cardiovascular physiology during early neonatal life.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 37 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm neonates with gestational age <37 weeks
- •Receiving caffeine therapy for apnea of prematurity
- •Hemodynamically stable before caffeine initiation
排除标准
- •Presence of major congenital anomalies
- •Use of vasopressors at baseline
- •Severe intraventricular hemorrhage (Grade III-IV)
结局指标
主要结局
Change in mean arterial blood pressure after caffeine therapy in preterm neonates.
时间窗: Baseline before caffeine administration and at 1, 6, 12, and 24 hours after caffeine dose.
Mean change in mean arterial blood pressure (mmHg) in preterm neonates receiving caffeine therapy for apnea of prematurity, comparing post-caffeine values with baseline pre-caffeine values.
Change in perfusion index after caffeine therapy in preterm neonates.
时间窗: Baseline before caffeine administration and at 1, 6, 12, and 24 hours after caffeine dose.
Mean change in perfusion index (unitless value from pulse oximeter) in preterm neonates receiving caffeine therapy for apnea of prematurity, comparing post-caffeine values with baseline pre-caffeine values.
Change in heart rate after caffeine therapy in preterm neonates.
时间窗: Baseline before caffeine administration and at 1, 6, 12, and 24 hours after caffeine dose.
Mean change in heart rate (beats per minute) in preterm neonates receiving caffeine therapy for apnea of prematurity, comparing post-caffeine values with baseline pre-caffeine values, and documenting episodes of tachycardia defined as heart rate greater than 180 beats per minute.
次要结局
未报告次要终点
研究者
Margret Azer
Resident at Pediatric Department, Assiut University
Assiut University