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

NCT07274969 | Not Yet Recruiting

• 1 other identifier: caffeine therapy
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Apnea of Prematurity; Preterm Neonates

Keywords

Preterm neonates; apnea of prematurity

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (1)

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.

Eligibility Criteria

• Age: Up to 37 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Preterm neonates with gestational age \<37 weeks
• Receiving caffeine therapy for apnea of prematurity
• Hemodynamically stable before caffeine initiation

You may not qualify if:

• Presence of major congenital anomalies
• Use of vasopressors at baseline
• Severe intraventricular hemorrhage (Grade III-IV)

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Apnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at Pediatric Department, Assiut University

Study Record Dates

• First Submitted: September 28, 2025
• First Posted: December 10, 2025
• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: December 10, 2025

Record last verified: 2025-12