Direct Effect of Caffeine on Diaphragmatic Muscles

NCT ID: NCT04483492

Last Updated: 2020-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

56 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-01

Study Completion Date

2020-12-01

Brief Summary

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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

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Conditions

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Caffeine

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

newborns under 32 weeks with respiratory support if they are decided to start caffeine treatment

Caffeine citrate

Intervention Type DRUG

diaphragm contractility after administration

Interventions

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Caffeine citrate

diaphragm contractility after administration

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* babies with congenital malformations
Minimum Eligible Age

1 Day

Maximum Eligible Age

7 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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H. Tolga Çelik

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hacettepe University

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Hasan Tolga Celik, MD

Role: CONTACT

+905305925584

Facility Contacts

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Hasan Tolga Celik, MD

Role: primary

+905305925584

References

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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.

Reference Type BACKGROUND
PMID: 25982138 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39140727 (View on PubMed)

Other Identifiers

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KA-20029

Identifier Type: -

Identifier Source: org_study_id

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