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The Influences of Caffeine on Heart Rate Variability of Preterm Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01769118
Recruitment Status : Completed
First Posted : January 16, 2013
Last Update Posted : May 8, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Caffeine has a stimulatory effect on the ANS. This has not yet been investigated in preterm infant who get caffeine before stopping ventilation. The investigators hypothesis is that this stimulatory effect may be characterized by HRV analysis methods.

Condition or disease Intervention/treatment
Autonomic Nervous System Drug: Caffeine

Study Design

Study Type : Observational
Actual Enrollment : 25 participants
Time Perspective: Prospective
Official Title: The Influences of Caffeine on HRV of Preterm Infants
Study Start Date : January 2013
Primary Completion Date : January 2014
Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Caffeine
caffeine will be given according to clinical judgment
Drug: Caffeine
Caffeine will be given according to departmental protocol


Outcome Measures

Primary Outcome Measures :
  1. Heart rate variability [ Time Frame: 1 hour ]
    Heart rate, SD, SDNN, HF, LF, VLF, TP


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Weeks to 34 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
25 preterm infants
Criteria

Inclusion Criteria:

  • infants born before 34 weeks gestation

Exclusion Criteria:

  • sepsis
  • congenital malformations
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01769118


Locations
Israel
RMC
Haifa, Israel
Sponsors and Collaborators
Rambam Health Care Campus
More Information

Responsible Party: wamir, Dr., Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01769118     History of Changes
Other Study ID Numbers: 0442-12
First Posted: January 16, 2013    Key Record Dates
Last Update Posted: May 8, 2015
Last Verified: May 2015

Keywords provided by wamir, Rambam Health Care Campus:
Autonomic nervous system

Additional relevant MeSH terms:
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents