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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07274969

Enrollment

Registered

2025-12-10

Start date

2026-06-30

Completion date

2027-12-30

Last updated

2025-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apnea of Prematurity, Preterm Neonates

Keywords

Preterm neonates, apnea of prematurity

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 37 Weeks

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)

Design outcomes

Primary

Measure	Time frame	Description
Change in mean arterial blood pressure after caffeine therapy in preterm neonates.	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.	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.	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.

Outcome results