Premature Newborn
Conditions
Keywords
Echocardiography, postural support, preterm neonate
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.
Interventions
PROCEDUREechocardiography with postural support
PROCEDUREechocardiography with standard condition (usual)
Sponsors
University Hospital, Montpellier
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Minutes to 1 Days
Healthy volunteers
No
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
France
Outcome results
None listed