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

Assiut University

Status: Begins enrollment in 4 months

Conditions: Preterm Neonates; Apnea of Prematurity

Study type: Observational

Funder types: Other

Identifiers

NCT07274969

caffeine therapy

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: Under 37 weeks old

Volunteers: No Healthy Volunteers

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)

Trial design

40 participants in 1 patient group

Preterm neonates

Description:

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.