Effect of prophylactic caffeine on the sleep/wake cycles (SWC) in preterm neonates.

Effect of prophylactic caffeine on the sleep/wake cycles (SWC) in preterm neonates with RDS treated with nasal CPAP with a gestational age of 28-35 weeks.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20170627034782N3

Enrollment

Registered

2022-07-06

Start date

2022-09-23

Completion date

Unknown

Last updated

2022-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The effect of caffeine in quantity and quality of sleep/wake cycle in newborns by using of aEEG.

Interventions

Intervention 1: Intervention group: In the caffeine group (F), the premature neonates with a gestational age of 28- 35 weeks with RDS and requiring nCPAP will be receive 20 mg/kg caffeine as the ini

Eligibility

Sex/Gender

All

Age

1 Days to 1 Days

Inclusion criteria

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

Exclusion criteria: Perinatal Asphyxia ( apgar score fifth minute=0-3, umbilical cord PH180), Neonate not requiring nasal CPAP till 48 hours after birth.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Ramin Iranpour

Esfahan University of Medical Sciences

iranpour@med.mui.ac.ir+98 31 3668 1555

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026