Effect of prophylactic caffeine on the sleep/wake cycles (SWC) in preterm neonates.
Phase 3
- Conditions
- The effect of caffeine in quantity and quality of sleep/wake cycle in newborns by using of aEEG.
- Registration Number
- IRCT20170627034782N3
- Lead Sponsor
- Esfahan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 34
Inclusion Criteria
Preterm neonate with a gestational age of 28-35 weeks,
Spontaneous breathing with clinical sign and symptom of RDS requiring nasal CPAP.
Exclusion Criteria
Perinatal Asphyxia ( apgar score fifth minute=0-3, umbilical cord PH<7, umbilical cord bicarbonate <12 meq/l),
Evidence of PDA which is confirmed by echocardiography,
Evidence of IVH ( grade 3-4) which is confirmed by cranial sonography,
Existence of air leakage,
Neonate with congenital brain anomaly,
Neonate with tachycardia (heart rate >180),
Neonate not requiring nasal CPAP till 48 hours after birth.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The number of sleep-wake cycle during of one 24 hour. Timepoint: From 48 hours after birth till 24 hour later continuously. Method of measurement: Brain monitoring with amplitude Electroencephalography (aEEG).
- Secondary Outcome Measures
Name Time Method Apnea of prematurity. Timepoint: 24 hour cardio-respiratory monitoring. Method of measurement: pulse oximeter with Spo2 continuous monitoring.;The mean duration of active phase of sleep. Timepoint: From 48 hours after birth till 24 hour later continuously. Method of measurement: Brain monitoring with amplitude Electroencephalography (aEEG).;The mean duration of quiet phase of sleep. Timepoint: From 48 hours after birth till 24 hour later continuously. Method of measurement: Brain monitoring with amplitude Electroencephalography (aEEG).;The mean heart rate. Timepoint: Every 6 hour, since birth till 72 hour after birth. Method of measurement: Cardio-respiratory monitoring by pulse oximeter.;The mean arterial oxygen saturation. Timepoint: Every 6 hour, since birth till 72 hour after birth. Method of measurement: Every 6 hour, since birth till 72 hour after birth.;Chronic lung disease. Timepoint: Daily. Method of measurement: Physical exam and chest xray.