Direct Effect of Caffeine on Diaphragmatic Muscles

NCT04483492 | Unknown FDA Drug

• 1 other identifier: KA-20029
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Caffeine

Outcome Measures

Primary Outcomes (1)

• diphragmatic contractility

  diphragmatic contractility measured by ultrasonographic evaluation

  30 minutes

Study Arms (1)

1

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

Drug: Caffeine citrate

Interventions

Caffeine citrate DRUG

diaphragm contractility after administration

1

Eligibility Criteria

• Age: 1 Day - 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

newborns under 32 weeks with respiratory support on their first week

You may qualify if:

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

You may not qualify if:

• babies with congenital malformations

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• 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.

  PMID: 25982138 BACKGROUND

• 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.

  PMID: 39140727 DERIVED

MeSH Terms

Interventions

caffeine citrate

Central Study Contacts

Hasan Tolga Celik, MD

CONTACT

+905305925584; htcelik@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 25, 2020
• First Posted: July 23, 2020
• Study Start: March 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: July 23, 2020

Record last verified: 2020-07

Locations

TU (1)