Direct Effect of Caffeine on Diaphragmatic Muscles | NCT04483492

Studies
Direct Effect of Caffeine on Diaphragmatic Muscles

NCT04483492

Sponsor

Hacettepe University

Status

Unknown status

Last Update Posted

Jul 23, 2020Actual

Enrollment

56Estimated

Phase

Not provided

Conditions

Caffeine

Interventions

Caffeine citrate

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2019Actual

Primary Completion Date

Dec 1, 2020Estimated

Completion Date

Dec 1, 2020Estimated

First Submitted Date

Jun 25, 2020

First Submission Date that Met QC Criteria

Jul 20, 2020

First Posted Date

Jul 23, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 20, 2020

Last Update Posted Date

Jul 23, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

H. Tolga Çelik, Principal Investigator, Hacettepe UniversityPrincipal Investigator

Lead Sponsor

Hacettepe UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The mechanism of methylxanthines is thought to increase chemoreceptor responsiveness to CO2 in central nervous system. Besides, effect of methylxanthines on diaphragmatic contractility has also been found in experimental studies. A study of premature newborns has showed caffeine increase diaphragmatic activity and tidal volume. But, there is limited data about caffeine direct effect on diaphragma.

Objective: The investigators aimed to show the direct effect of caffeine on diphragmatic contractility.

Method: The babies under 32 weeks with respiratory support, are being enrolled in this study if caffeine treatment is decided to receive. Evaluation of muscle contraction is being made by ultrasound before and 30 minutes after caffeine loading dose. Right and left sides of diaphragm thickness are being measured by two clinicians on B mode ultrasound by anterior subcostal view. The velocity before and after caffeine administration will be calculated, dividing excursion frequency (parameter) for inspiratory time. Movement of the diaphragm at inspiratory and expiratory phases are also observed on M mode and the difference between the two phases are measured.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

56Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		newborns under 32 weeks with respiratory support if they are decided to start caffeine treatment	Drug: Caffeine citrate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Caffeine citrate	Drug	diaphragm contractility after administration	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
diphragmatic contractility	diphragmatic contractility measured by ultrasonographic evaluation	30 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

newborns under 32 weeks with respiratory support
caffeine is decided to give

Exclusion Criteria:

babies with congenital malformations

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

7 Days

Standard Ages

Child

Study Population

newborns under 32 weeks with respiratory support on their first week

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hasan Tolga Celik, MD	Contact	+905305925584		htcelik@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hacettepe University	Recruiting	Ankara			Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25982138	Background	Kraaijenga JV, Hutten GJ, de Jongh FH, van Kaam AH. The Effect of Caffeine on Diaphragmatic Activity and Tidal Volume in Preterm Infants. J Pediatr. 2015 Jul;167(1):70-5. doi: 10.1016/j.jpeds.2015.04.040. Epub 2015 May 15.
39140727	Derived	Kayki G, Celik HT, Ayaz E, Tandircioglu UA, Oguz B, Yigit S, Yurdakok M. Direct Effect of Caffeine on Diaphragmatic Muscles in Preterm Babies Through Ultrasonographic Examination. Turk Arch Pediatr. 2024 Apr 5;59(3):277-282. doi: 10.5152/TurkArchPediatr.2024.23290.