NCT01769118

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 16, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

May 8, 2015

Status Verified

May 1, 2015

Enrollment Period

1 year

First QC Date

January 14, 2013

Last Update Submit

May 6, 2015

Conditions

Autonomic Nervous System

Keywords

Autonomic nervous system

Outcome Measures

Primary Outcomes (1)

  • Heart rate variability

    Heart rate, SD, SDNN, HF, LF, VLF, TP

    1 hour

Study Arms (1)

Caffeine

caffeine will be given according to clinical judgment

Drug: Caffeine

Interventions

CaffeineDRUG

Caffeine will be given according to departmental protocol

Caffeine

Eligibility Criteria

Age25 Weeks - 34 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

25 preterm infants

You may qualify if:

  • infants born before 34 weeks gestation

You may not qualify if:

  • sepsis
  • congenital malformations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RMC

Haifa, Israel

Location

MeSH Terms

Interventions

Caffeine

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

January 14, 2013

First Posted

January 16, 2013

Study Start

January 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

May 8, 2015

Record last verified: 2015-05

Locations

IL(1)