Conditions of Realization of the Echocardiography in Newborns

Study Overview
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Brief Summary
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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.

Official Title
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Does Postural Support During Echocardiography Modify Hemodynamic Features and Discomfort Induced by the Examination in Very Premature Neonates?

Conditions
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Premature Newborn

Intervention / Treatment
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* Procedure: echocardiography with postural support
* Procedure: echocardiography with standard condition (usual)


Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 1 Day

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: echocardiography with postural support then standard condition<br>the first echocardiography (ultrasound) is performed with a postural support then the second echocardiography is performed with standard condition | Procedure: echocardiography with postural support<br> <br> Procedure: echocardiography with standard condition (usual)<br> <br> |
| Active Comparator: echocardiography with standard condition then support postural<br>the first echocardiography (ultrasounds) is performed with standard condition (usual) and the second echocardiography is performed with a postural support | Procedure: echocardiography with postural support<br> <br> Procedure: echocardiography with standard condition (usual)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| value of the ratio of the acceleration time of pulmonary arterial flow. | for each echocardiography (support condition and postural support) | up to 1 hour | 
| value of the ejection time of pulmonary arterial flow | for each echocardiography (support condition and postural support) | up to 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain assessment with a clinical scale | assessment of the pain with a practical behavioral observation scale | up to 1 hour | 
| number of participant with a Patent ductus arteriosus shunt |  | up to 2 hours | 
| systolic pulmonary arterial pressure |  | up to 2 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Echocardiography, postural support, preterm neonate