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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| echocardiography with postural support then standard condition | Experimental | the first echocardiography (ultrasound) is performed with a postural support then the second echocardiography is performed with standard condition |
|
| echocardiography with standard condition then support postural | Active Comparator | the first echocardiography (ultrasounds) is performed with standard condition (usual) and the second echocardiography is performed with a postural support |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| echocardiography with postural support | Procedure |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University hospital of Montpellier | Montpellier | 34295 | France |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| echocardiography with standard condition (usual) | Procedure |
|
| systolic pulmonary arterial pressure | up to 2 hour |
| D000091642 | Urogenital Diseases |