Caffeine for Preterm Infants With Apnea of Prematurity(AOP)

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

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.

Study Overview

• Status: Unknown
• Conditions: Apnea of Prematurity; Caffeine
• Intervention / Treatment: Drug: 80mg/kg of caffeine; Drug: 20mg/kg of caffeine

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ma Juan, MD; Phone Number: 18680887330; Email: 416767068@qq.com
• Study Contact Backup: Name: Shi Yuan, MD;PhD; Phone Number: 13508300283; Email: petshi530@vip.163.com

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400042
      • Recruiting
      • Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 minute to 1 month (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• major congenital abnormalities;
• Parents' rejection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 80mg/kg of caffeine; 80mg/kg of caffeine is given to treat AOP.	Drug: 80mg/kg of caffeine; 80mg/kg of caffeine is given to treat AOP
Active Comparator: 20mg/kg of caffeine; 20mg/kg of caffeine is given to treat AOP.	Drug: 20mg/kg of caffeine; 20mg/kg of caffeine is given to treat AOP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the rate of AOP	AOP appears again in preterm infants	within 100 days

Collaborators and Investigators

• Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Investigators: Study Director: Shi Yuan, MD;PhD, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2017
• Primary Completion (Anticipated): October 1, 2018
• Study Completion (Anticipated): October 1, 2018

Study Registration Dates

• First Submitted: September 27, 2017
• First Submitted That Met QC Criteria: September 27, 2017
• First Posted (Actual): October 2, 2017

Study Record Updates

• Last Update Posted (Actual): October 2, 2017
• Last Update Submitted That Met QC Criteria: September 27, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Apnea; Premature Birth; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Purinergic Antagonists; Purinergic Agents; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Central Nervous System Stimulants; Caffeine
• Other Study ID Numbers: 201733

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No