Conditions of Realization of the Echocardiography in Newborns

Not Applicable

Completed

• Conditions: Premature Newborn
• Interventions: Procedure: echocardiography with postural support; Procedure: echocardiography with standard condition (usual)

• Registration Number: NCT02893956
• Lead Sponsor: University Hospital, Montpellier

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Study First Submitted: 2016-07-21
• Status Verified: 2016-08
• Study First Submitted QC: 2016-09-02
• Last Update Submitted: 2016-09-02
• Study First Posted: 2016-09-09
• Last Update Posted: 2016-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
echocardiography with postural support then standard condition	echocardiography with standard condition (usual)	the first echocardiography (ultrasound) is performed with a postural support then the second echocardiography is performed with standard condition
echocardiography with postural support then standard condition	echocardiography with postural support	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	echocardiography with standard condition (usual)	the first echocardiography (ultrasounds) is performed with standard condition (usual) and the second echocardiography is performed with a postural support
echocardiography with standard condition then support postural	echocardiography with postural support	the first echocardiography (ultrasounds) is performed with standard condition (usual) and the second echocardiography is performed with a postural support

Primary Outcome Measures

Name	Time	Method
value of the ratio of the acceleration time of pulmonary arterial flow.	up to 1 hour	for each echocardiography (support condition and postural support)
value of the ejection time of pulmonary arterial flow	up to 1 hour	for each echocardiography (support condition and postural support)

Secondary Outcome Measures

Name	Time	Method
pain assessment with a clinical scale	up to 1 hour	assessment of the pain with a practical behavioral observation scale
number of participant with a Patent ductus arteriosus shunt	up to 2 hours
systolic pulmonary arterial pressure	up to 2 hour

Trial Locations

Locations (1)

University hospital of Montpellier; 🇫🇷 Montpellier, France