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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Apnea of Prematurity; Preterm Neonates

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 Type: Observational
• Enrollment (Estimated): 40

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Preterm neonates receiving standard caffeine citrate therapy for apnea of prematurity, including a loading dose of 20-25 mg/kg followed by maintenance dosing (5-10 mg/kg daily). Cardiovascular parameters and side effects are monitored longitudinally.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Preterm neonates; Preterm neonates receiving standard caffeine citrate therapy for apnea of prematurity, including a loading dose of 20-25 mg/kg followed by maintenance dosing (5-10 mg/kg daily). Cardiovascular parameters and side effects are monitored longitudinally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline before caffeine administration and at 1, 6, 12, and 24 hours after caffeine dose.

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: September 28, 2025
• First Submitted That Met QC Criteria: December 9, 2025
• First Posted (Actual): December 10, 2025

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: apnea of prematurity; Preterm neonates
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Apnea
• Other Study ID Numbers: caffeine therapy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No