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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
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Premature Newborn focused on measuring Echocardiography, postural support, preterm neonate

Eligibility Criteria

1 Minute - 1 Day (Child)All SexesDoes not accept healthy volunteers

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

First Posted
July 21, 2016
Last Updated
September 2, 2016
Sponsor
University Hospital, Montpellier
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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

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Conditions of Realization of the Echocardiography in Newborns

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