Conditions of Realization of the Echocardiography in Newborns

Premature Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02893956
• Other study ID #: 9252
• Status: Completed
• Phase: N/A
• First received: July 21, 2016
• Last updated: September 2, 2016
• Start date: April 2014
• Est. completion date: June 2015

Study information

• Verified date: August 2016
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Day

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Premature Birth
• Premature Newborn

Intervention

Procedure:
• echocardiography with postural support

• echocardiography with standard condition (usual)

Locations

Country	Name	City	State
France	University hospital of Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	value of the ratio of the acceleration time of pulmonary arterial flow.	for each echocardiography (support condition and postural support)	up to 1 hour	No
Primary	value of the ejection time of pulmonary arterial flow	for each echocardiography (support condition and postural support)	up to 1 hour	No
Secondary	pain assessment with a clinical scale	assessment of the pain with a practical behavioral observation scale	up to 1 hour	No
Secondary	number of participant with a Patent ductus arteriosus shunt		up to 2 hours	No
Secondary	systolic pulmonary arterial pressure		up to 2 hour	No