Conditions of Realization of the Echocardiography in Newborns

University Hospital Center (CHU)

Status: Completed

Conditions: Premature Newborn

Treatments: Procedure: echocardiography with standard condition (usual); Procedure: echocardiography with postural support

Study type: Interventional

Funder types: Other

Identifiers

NCT02893956

9252

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 1 minute to 1 day old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

echocardiography with postural support then standard condition

Experimental group

Description:

the first echocardiography (ultrasound) is performed with a postural support then the second echocardiography is performed with standard condition

Treatment:

Procedure: echocardiography with standard condition (usual)

Procedure: echocardiography with postural support

echocardiography with standard condition then support postural

Active Comparator group

Description:

the first echocardiography (ultrasounds) is performed with standard condition (usual) and the second echocardiography is performed with a postural support

Treatment:

Procedure: echocardiography with standard condition (usual)

Procedure: echocardiography with postural support