ClinicalTrials.gg
Sign In
Status unknownNCT03298347Updated Oct 2, 2017

Caffeine for Preterm Infants With Apnea of Prematurity(AOP)

An interventional study of 80mg/kg of caffeine and 20mg/kg of caffeine in Caffeine and Apnea of Prematurity, sponsored by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University. Status unknown at 1 site in China. Open to participants aged 1 Minute to 1 Month. Per ClinicalTrials.gov, last updated 2017-10-02.

Sponsored by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
1 Minute to 1 Month
Sex
All
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Caffeine
  • Apnea of Prematurity

Browse trials for

03

In context

Apnea

1,417 studies on the registry are indexed under Apnea; 152 are open to participants now.

This study's planned enrollment of 100 is above the median of 51 across 962 interventional studies indexed under Apnea.

Browse Apnea studies →

Lead sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University is the lead sponsor of 120 studies on the registry; 42 are open to participants now.

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

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Minute to 1 Month
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • major congenital abnormalities;
  • Parents' rejection
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    80mg/kg of caffeine

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

    Drug: 80mg/kg of caffeine

  • Active comparator
    20mg/kg of caffeine

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

    Drug: 20mg/kg of caffeine

Interventions

  • Drug80mg/kg of caffeine

    80mg/kg of caffeine is given to treat AOP

  • Drug20mg/kg of caffeine

    20mg/kg of caffeine is given to treat AOP

06

What researchers measure

Primary outcomes

  1. the rate of AOP

    AOP appears again in preterm infants

    Time frame: within 100 days

07

Study locations

1 of 1 sites recruiting
  • Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
    Chongqing, Chongqing Municipality 400042, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2017; primary completion for Oct 2018, 12 months later.

Of 296 non-industry interventional studies with no phase under Apnea, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 12 months is below that.

Counting every sponsor, half of 354 studies reached it within 23 months; a quarter within 11 and three quarters within 45.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 27, 2017
First posted
Oct 2, 2017
StartEst.
Oct 1, 2017
Primary completionEst.
Oct 1, 2018
CompletionEst.
Oct 1, 2018
Last update
Oct 2, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 2, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03298347
Lead sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Responsible party
Ma Juan (Director, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University) — Principal investigator
First posted
Oct 2, 2017
Start date
Oct 1, 2017 (estimated)
Primary completion
Oct 1, 2018 (estimated)
Completion
Oct 1, 2018 (estimated)
Last update
Oct 2, 2017

Study contacts

Ma Juan, MD
Contact
416767068@qq.com
18680887330
Shi Yuan, MD;PhD
Contact
petshi530@vip.163.com
13508300283
Shi Yuan, MD;PhD
study director · Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Apnea →

Other studies from this sponsor

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

Start the discussion