NCT03298347

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

October 2, 2017

Status Verified

September 1, 2017

Enrollment Period

1 year

First QC Date

September 27, 2017

Last Update Submit

September 27, 2017

Conditions

CaffeineApnea of Prematurity

Outcome Measures

Primary Outcomes (1)

  • the rate of AOP

    AOP appears again in preterm infants

    within 100 days

Study Arms (2)

80mg/kg of caffeine

EXPERIMENTAL

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

Drug: 80mg/kg of caffeine

20mg/kg of caffeine

ACTIVE COMPARATOR

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

Drug: 20mg/kg of caffeine

Interventions

80mg/kg of caffeineDRUG

80mg/kg of caffeine is given to treat AOP

80mg/kg of caffeine
20mg/kg of caffeineDRUG

20mg/kg of caffeine is given to treat AOP

20mg/kg of caffeine

Eligibility Criteria

Age1 Minute - 1 Month
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • major congenital abnormalities;
  • Parents' rejection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Chongqing, Chongqing Municipality, 400042, China

RECRUITING

MeSH Terms

Conditions

Apnea

Interventions

Caffeine

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Shi Yuan, MD;PhD

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

    STUDY DIRECTOR

Central Study Contacts

Ma Juan, MD

CONTACT

18680887330416767068@qq.com

Shi Yuan, MD;PhD

CONTACT

13508300283petshi530@vip.163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

September 27, 2017

First Posted

October 2, 2017

Study Start

October 1, 2017

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

October 2, 2017

Record last verified: 2017-09

Locations

CN(1)