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?

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.

Study Overview

• Status: Completed
• Conditions: Premature Newborn
• Intervention / Treatment: Procedure: echocardiography with postural support; Procedure: echocardiography with standard condition (usual)

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • University hospital of Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 minute to 1 day (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: echocardiography with postural support then standard condition; the first echocardiography (ultrasound) is performed with a postural support then the second echocardiography is performed with standard condition	Procedure: echocardiography with postural support; Procedure: echocardiography with standard condition (usual)
Active Comparator: echocardiography with standard condition then support postural; the first echocardiography (ultrasounds) is performed with standard condition (usual) and the second echocardiography is performed with a postural support	Procedure: echocardiography with postural support; Procedure: echocardiography with standard condition (usual)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
systolic pulmonary arterial pressure		up to 2 hour

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: July 21, 2016
• First Submitted That Met QC Criteria: September 2, 2016
• First Posted (Estimate): September 9, 2016

Study Record Updates

• Last Update Posted (Estimate): September 9, 2016
• Last Update Submitted That Met QC Criteria: September 2, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Echocardiography; preterm neonate; postural support
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: 9252

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO