MedDataX Logo

Caffeine for Preterm Infants With Apnea of Prematurity(AOP)

NCT ID: NCT03298347

Last Updated: 2017-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2018-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Caffeine Apnea of Prematurity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

80mg/kg of caffeine

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

Group Type EXPERIMENTAL

80mg/kg of caffeine

Intervention Type DRUG

80mg/kg of caffeine is given to treat AOP

20mg/kg of caffeine

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

Group Type ACTIVE_COMPARATOR

20mg/kg of caffeine

Intervention Type DRUG

20mg/kg of caffeine is given to treat AOP

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

80mg/kg of caffeine

80mg/kg of caffeine is given to treat AOP

Intervention Type DRUG

20mg/kg of caffeine

20mg/kg of caffeine is given to treat AOP

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* major congenital abnormalities;
* Parents' rejection
Minimum Eligible Age

1 Minute

Maximum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

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

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ma Juan

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Shi Yuan, MD;PhD

Role: STUDY_DIRECTOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ma Juan, MD

Role: CONTACT

[email protected]
18680887330

Shi Yuan, MD;PhD

Role: CONTACT

[email protected]
13508300283

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Shi Yuan, PhD,MD

Role: primary

[email protected]
13508300283

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

201733

Identifier Type: -

Identifier Source: org_study_id