An interventional study of echocardiography with postural support and echocardiography with standard condition (usual) in Premature Newborn, sponsored by University Hospital, Montpellier. Completed at 1 site in France. Open to participants aged 1 Minute to 1 Day. Per ClinicalTrials.gov, last updated 2016-09-09.
Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Prevention
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.
2,615 studies on the registry are indexed under Premature Birth; 507 are open to participants now.
This study's enrollment of 30 is below the median of 84 across 1,722 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →University Hospital, Montpellier is the lead sponsor of 1,261 studies on the registry; 226 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
-
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)
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)
value of the ratio of the acceleration time of pulmonary arterial flow.
for each echocardiography (support condition and postural support)
Time frame: up to 1 hour
value of the ejection time of pulmonary arterial flow
for each echocardiography (support condition and postural support)
Time frame: up to 1 hour
pain assessment with a clinical scale
assessment of the pain with a practical behavioral observation scale
Time frame: up to 1 hour
number of participant with a Patent ductus arteriosus shunt
Time frame: up to 2 hours
systolic pulmonary arterial pressure
Time frame: up to 2 hour
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of Apr 2014, a primary completion of Jun 2015 and a completion of Jun 2015. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Montpellier →