An observational study in Preterm Neonates and Apnea of Prematurity, sponsored by Assiut University. Not yet recruiting. Open to participants aged Up to 37 Weeks. Per ClinicalTrials.gov, last updated 2025-12-10.
Sponsored by Assiut University · Observational
Preterm neonates younger than 37 weeks gestational age receiving caffeine therapy for apnea of prematurity in a NICU setting.
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.
282 studies on the registry are indexed under Apnea; 54 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 78 observational studies indexed under Apnea.
Browse Apnea studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
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Exclusion Criteria:
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.
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.
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.
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.
No study locations are listed for this record.
Start is estimated for Jun 2026; primary completion for Aug 2027, 14 months later.
Of 35 observational studies under Apnea, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 38. This study's planned 14 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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