Caffeine for Preterm Infants With Apnea of Prematurity(AOP)

Army Medical University of People's Liberation Army

Status: Unknown

Conditions: Caffeine; Apnea of Prematurity

Treatments: Drug: 20mg/kg of caffeine; Drug: 80mg/kg of caffeine

Study type: Interventional

Funder types: Other

Identifiers

NCT03298347

201733

Details and patient eligibility

About

Nowadays,caffein is commonly used for AOP, and it reduces the intubation rate in preterm infants. However, intubation is needed in about 20%-50% of partial neonates. How to reduce the intubation rate effectively is a challenge for neonatologists.

Full description

Less evidences about more dose of caffein used in preterm infants.

Enrollment: 100 estimated patients

Sex: All

Ages: 1 minute to 1 month old

Volunteers: No Healthy Volunteers

Inclusion criteria

• gestational age less than 32 weeks;
• appear AOP;
• parents'consents are obtained.

Exclusion criteria

• major congenital abnormalities;
• Parents' rejection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

80mg/kg of caffeine

Experimental group

Description:

80mg/kg of caffeine is given to treat AOP.

Treatment:

Drug: 80mg/kg of caffeine

20mg/kg of caffeine

Active Comparator group

Description:

20mg/kg of caffeine is given to treat AOP.

Treatment:

Drug: 20mg/kg of caffeine