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Comparing The Prophylactic Effects of Caffeine versus Aminophylline on the Apnea of Prematurity in Neonates of Kabul City: A randomized clinical trial

Comparing The Prophylactic Effects of Caffeine versus Aminophylline on the Apnea of Prematurity in Neonates of Kabul City: A randomized clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
DRKS
Registry ID
DRKS00020404
Enrollment
80
Registered
2020-03-16
Start date
2023-06-29
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Prematurity and low birth weight P07

Interventions

Group 1: 40 neonates in group A will be managed by Caffeine citrate 20 mg/kg intravenously as the initial dose on the 1st day of life, and then 5 mg/kg intravenously daily as the maintenance dose for

Sponsors

Ministry of Higher Education, Research Committee
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to 8 Days

Inclusion criteria

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

Exclusion criteria: Neonates have visible or physically detected malformation, birth asphyxia, and parent who declined consent

Design outcomes

Primary

MeasureTime frame
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. 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.

Secondary

MeasureTime frame
1- The duration of oxygen therapy in days. Oxygen treatment is indicated when oxygen saturation falls below the target level (85% for neonates equal or more than 28 weeks gestation and 91% for neonates less than 28 weeks gestation), and the development of apnea, or cyanosis. 2- The duration of mechanical ventilation is days. The indications for initiation of mechanical ventilation are: PaO2 60 mmHg, intractable or recurrent apnea, gasping or poor respiration, O2 saturation 60 mmHg) despite CPAP pressure of 7–8 cm H2O and FiO2 of 0.8 or recurrent episodes of apnea. 3- The proportion of neonates who need mechanical ventilation. 4- The relative risks of neonatal irritability (excessive crying for more than 4hr), tachycardia (heart rate more than 180beats/minute), seizure (involuntary movements with disturbed conscious) and death during the intervention period. All are possible side effects of Caffeine citrate.

Countries

Afghanistan

Contacts

Public ContactMansoor Aslamzai

Kabul University of Medical science

mansooraslamzai@gmail.com+93700603998

Outcome results

None listed

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