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
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Assiut University
- Enrollment
- 40
- Primary Endpoint
- Change in mean arterial blood pressure after caffeine therapy in preterm neonates.
Overview
Brief Summary
Preterm neonates younger than 37 weeks gestational age receiving caffeine therapy for apnea of prematurity in a NICU setting.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- — to 37 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Preterm neonates with gestational age \<37 weeks
- •Receiving caffeine therapy for apnea of prematurity
- •Hemodynamically stable before caffeine initiation
Exclusion Criteria
- •Presence of major congenital anomalies
- •Use of vasopressors at baseline
- •Severe intraventricular hemorrhage (Grade III-IV)
Outcomes
Primary Outcomes
Change in mean arterial blood pressure after caffeine therapy in preterm neonates.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Margret Azer
Resident at Pediatric Department, Assiut University
Assiut University