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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 37
SponsorAssiut University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Preterm neonates with gestational age <37 weeks

Receiving caffeine therapy for apnea of prematurity

Hemodynamically stable before caffeine initiation

Disqualifiers

Presence of major congenital anomalies

Use of vasopressors at baseline

Severe intraventricular hemorrhage (Grade III-IV)

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

40 Participants
are grouped into 1 trial group
Group A: Preterm neonates

Trial outcomes

Primary outcomes

1

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.
2

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.
3

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.

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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