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Not yet recruiting NCT07274969

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

Observational Preterm Neonates Apnea of Prematurity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Preterm Neonates, Apnea of Prematurity. Basic parameters: up to 37 Weeks · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Change in mean arterial blood pressure after caffeine therapy in preterm neonates. [Time frame: 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. [Time frame: 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. [Time frame: Baseline before caffeine administration and at 1, 6, 12, and 24 hours after caffeine dose.]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07274969 · caffeine therapy

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗