Comparing The Prophylactic Effects of Caffeine versus Aminophylline on the Apnea of Prematurity in Neonates of Kabul City: A randomized clinical trial
Phase 4
- Conditions
- Prematurity and low birth weightP07Disorders related to short gestation and low birth weight, not elsewhere classified
- Registration Number
- DRKS00020404
- Lead Sponsor
- Ministry of Higher Education, Research Committee
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
Preterm neonates who fulfill both of the following criteria will be enrolled in the study.
• Gestational age =34weeks.
• Weight less than 1500g.
Exclusion Criteria
Neonates have visible or physically detected malformation, birth asphyxia, and parent who declined consent
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1- The risk of apnea: Apnea is defined as a cessation of breathing for 20 seconds or longer, or a shorter pause accompanied by bradycardia (heart rate less than 100 beats per minute for 4 seconds or longer), or low blood oxygen saturation (SpO2 less than 80% for 4 second or longer) in infants less than 37 weeks of gestation. The apnea will be diagnosed by a Cardio-respiratory Monitor. Persistent of apnea attacks in preterm neonates with no other obvious causes or despite the correction of secondary causes is accepted as apnea of prematurity. The risk of apnea a group would be calculated from the number of preterm neonates with newly diagnosed apnea during 10 days of intervention divided by the number of total preterm neonates of the same group and date.<br>2- The total duration of apnea attacks will be demonstrated in days. The duration of apnea attacks will be calculated from the starting day up to the ending day of apnea.<br>
- Secondary Outcome Measures
Name Time Method