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

NCT ID: NCT07274969

Last Updated: 2025-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-06-30

Study Completion Date

2027-12-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Preterm Neonates Apnea of Prematurity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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)
Maximum Eligible Age

37 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Margret Azer

Resident at Pediatric Department, Assiut University

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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caffeine therapy

Identifier Type: -

Identifier Source: org_study_id

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