Caffeine for Preterm Infants With Apnea of Prematurity(AOP)

Caffeine Clinical Trial

Official title:

Caffeine for Preterm Infants With Apnea of Prematurity(AOP): a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03298347
• Other study ID #: 201733
• Status: Recruiting
• Phase: N/A
• First received: September 27, 2017
• Last updated: September 27, 2017
• Start date: October 1, 2017
• Est. completion date: October 1, 2018

Study information

• Verified date: September 2017
• Source: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Contact: Ma Juan, MD
• Phone: 18680887330
• Email: 416767068[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 1, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Month

Eligibility

Inclusion Criteria:

• gestational age less than 32 weeks;

• appear AOP;

• parents'consents are obtained.

Exclusion Criteria:

• major congenital abnormalities;

• Parents' rejection

Related Conditions & MeSH terms

• Apnea
• Apnea of Prematurity
• Caffeine
• Premature Birth

Intervention

Drug:
• 80mg/kg of caffeine
80mg/kg of caffeine is given to treat AOP
• 20mg/kg of caffeine
20mg/kg of caffeine is given to treat AOP

Locations

Country	Name	City	State
China	Daping Hospital and the Research Institute of Surgery of the Third Military Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the rate of AOP	AOP appears again in preterm infants	within 100 days