NCT02893956

Conditions of Realization of the Echocardiography in Newborns

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 1 Minute – 1 Day
• Healthy volunteers: Not accepted

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.

Conditions

• Premature Newborn

Interventions

Type	Name	Description
PROCEDURE	echocardiography with postural support
PROCEDURE	echocardiography with standard condition (usual)

Timeline

• Start date: 2014-04-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2016-09-09
• Last updated: 2016-09-09

Locations

1 site across 1 country: France