The Effect of Caffeine Therapy in Cardiovascular Stability in Preterm Neonates at Assiut University Children Hospital NICU

N/ANot Yet RecruitingNCT07274969

Assiut University40 enrolled

Overview

Preterm neonates younger than 37 weeks gestational age receiving caffeine therapy for apnea of prematurity in a NICU setting.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Preterm Neonates Apnea of Prematurity

Eligibility

Sex: ALLMax age: 37 Weeks

Medical Language ↔ Plain English

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.

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.

Time frame: Baseline before caffeine administration and at 1, 6, 12, and 24 hours after caffeine dose.

Change in perfusion index after caffeine therapy in preterm neonates.

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.

Time frame: Baseline before caffeine administration and at 1, 6, 12, and 24 hours after caffeine dose.

Change in heart rate after caffeine therapy in preterm neonates.

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.

Time frame: Baseline before caffeine administration and at 1, 6, 12, and 24 hours after caffeine dose.

Data from ClinicalTrials.gov

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