Conditions of Realization of the Echocardiography in Newborns
Primary Purpose
Premature Newborn
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
echocardiography with postural support
echocardiography with standard condition (usual)
Sponsored by

About this trial
This is an interventional prevention trial for Premature Newborn focused on measuring Echocardiography, postural support, preterm neonate
Eligibility Criteria
Inclusion Criteria:
- Newborn than 30 weeks of gestation neonates,
- Newborn with a post natal age < 48 hours,
- Newborn requiring invasive mechanical ventilation.
- Signed consent form of parent
Exclusion Criteria:
-
Sites / Locations
- University hospital of Montpellier
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
echocardiography with postural support then standard condition
echocardiography with standard condition then support postural
Arm Description
the first echocardiography (ultrasound) is performed with a postural support then the second echocardiography is performed with standard condition
the first echocardiography (ultrasounds) is performed with standard condition (usual) and the second echocardiography is performed with a postural support
Outcomes
Primary Outcome Measures
value of the ratio of the acceleration time of pulmonary arterial flow.
for each echocardiography (support condition and postural support)
value of the ejection time of pulmonary arterial flow
for each echocardiography (support condition and postural support)
Secondary Outcome Measures
pain assessment with a clinical scale
assessment of the pain with a practical behavioral observation scale
number of participant with a Patent ductus arteriosus shunt
systolic pulmonary arterial pressure
Full Information
NCT ID
NCT02893956
First Posted
July 21, 2016
Last Updated
September 2, 2016
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT02893956
Brief Title
Conditions of Realization of the Echocardiography in Newborns
Official Title
Does Postural Support During Echocardiography Modify Hemodynamic Features and Discomfort Induced by the Examination in Very Premature Neonates?
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Experimental nociceptive stimulation of the fetus and neonate induces pulmonary artery vasoconstriction. The investigators assessed whether echocardiography for Ductus arteriosus screening may generate this hemodynamic response and whether postural support would be able to modulate it.
Study design
Prospective, single center, randomized study in less than 29 weeks of gestation neonates, with a post natal age < 48 hours, and requiring invasive mechanical ventilation.
Crossover design with order of echocardiographies determined by computer randomization: in one group ultrasounds are performed with postural support, than standard conditions, in the other, ultrasounds are performed in standard conditions than with postural support.
The objective of the study is to assess the ratio of the acceleration time/ejection time of pulmonary arterial flow.
The others objectives are to assess echocardiographic-Doppler features (ductus arteriosus shunt pattern, pulmonary flow pattern, estimated systolic pulmonary arterial pressure, right and left ventricular functions using tissue Doppler imaging and speckle-tracking echocardiography), pain assessment with a clinical scale and heart rate variability analysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Newborn
Keywords
Echocardiography, postural support, preterm neonate
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
echocardiography with postural support then standard condition
Arm Type
Experimental
Arm Description
the first echocardiography (ultrasound) is performed with a postural support then the second echocardiography is performed with standard condition
Arm Title
echocardiography with standard condition then support postural
Arm Type
Active Comparator
Arm Description
the first echocardiography (ultrasounds) is performed with standard condition (usual) and the second echocardiography is performed with a postural support
Intervention Type
Procedure
Intervention Name(s)
echocardiography with postural support
Intervention Type
Procedure
Intervention Name(s)
echocardiography with standard condition (usual)
Primary Outcome Measure Information:
Title
value of the ratio of the acceleration time of pulmonary arterial flow.
Description
for each echocardiography (support condition and postural support)
Time Frame
up to 1 hour
Title
value of the ejection time of pulmonary arterial flow
Description
for each echocardiography (support condition and postural support)
Time Frame
up to 1 hour
Secondary Outcome Measure Information:
Title
pain assessment with a clinical scale
Description
assessment of the pain with a practical behavioral observation scale
Time Frame
up to 1 hour
Title
number of participant with a Patent ductus arteriosus shunt
Time Frame
up to 2 hours
Title
systolic pulmonary arterial pressure
Time Frame
up to 2 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Minute
Maximum Age & Unit of Time
1 Day
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Newborn than 30 weeks of gestation neonates,
Newborn with a post natal age < 48 hours,
Newborn requiring invasive mechanical ventilation.
Signed consent form of parent
Exclusion Criteria:
-
Facility Information:
Facility Name
University hospital of Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Conditions of Realization of the Echocardiography in Newborns
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