The Influences of Caffeine on Heart Rate Variability of Preterm Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
wamir, Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01769118
First received: January 14, 2013
Last updated: May 6, 2015
Last verified: May 2015
  Purpose
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 Intervention
Autonomic Nervous System
Drug: Caffeine

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: The Influences of Caffeine on HRV of Preterm Infants

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Heart rate variability [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Heart rate, SD, SDNN, HF, LF, VLF, TP


Enrollment: 25
Study Start Date: January 2013
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Caffeine
caffeine will be given according to clinical judgment
Drug: Caffeine
Caffeine will be given according to departmental protocol

  Eligibility

Ages Eligible for Study:   25 Weeks to 34 Weeks   (Child)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: January 14, 2013
Last Updated: May 6, 2015
Health Authority: Israel: Ministry of Health

Keywords provided by 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

ClinicalTrials.gov processed this record on July 26, 2016