Direct Effect of Caffeine on Diaphragmatic Muscles

Caffeine Clinical Trial

Official title:

Direct Effect of Caffeine on Diaphragmatic Muscles

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04483492
• Other study ID #: KA-20029
• Status: Recruiting
• Start date: March 1, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: July 2020
• Source: Hacettepe University
• Contact: Hasan Tolga Celik, MD
• Phone: +905305925584
• Email: htcelik[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 7 Days

Eligibility

Inclusion Criteria:

• newborns under 32 weeks with respiratory support

• caffeine is decided to give

Exclusion Criteria:

• babies with congenital malformations

Related Conditions & MeSH terms

• Caffeine

Intervention

Drug:
• Caffeine citrate
diaphragm contractility after administration

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diphragmatic contractility	diphragmatic contractility measured by ultrasonographic evaluation	30 minutes