Direct Effect of Caffeine on Diaphragmatic Muscles

• Conditions: Caffeine
• Interventions: Drug: Caffeine citrate

• Registration Number: NCT04483492
• Lead Sponsor: Hacettepe University

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 available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-03-01
• Study First Submitted: 2020-06-25
• Status Verified: 2020-07
• Study First Submitted QC: 2020-07-20
• Last Update Submitted: 2020-07-20
• Study First Posted: 2020-07-23
• Last Update Posted: 2020-07-23
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

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

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Exclusion Criteria

• babies with congenital malformations

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Caffeine citrate	newborns under 32 weeks with respiratory support if they are decided to start caffeine treatment

Primary Outcome Measures

Name	Time	Method
diphragmatic contractility	30 minutes	diphragmatic contractility measured by ultrasonographic evaluation

Trial Locations

Locations (1)

Hacettepe University; 🇹🇷 Ankara, Turkey