Premature NewbornNCT02893956
Conditions of Realization of the Echocardiography in Newborns
A study testing echocardiography with postural support and echocardiography with standard condition (usual) in people with Premature Newborn, run by University Hospital, Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 1 minute to 1 day
- Conditions the study is for
- Premature Newborn
- What is being tested?
- echocardiography with postural support and echocardiography with standard condition (usual)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2014to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 1 day
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read more
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
- Being tested
- echocardiography with postural support, echocardiography with standard condition (usual)
- Keywords
- Echocardiography, postural support, preterm neonate
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
echocardiography with postural supportProcedure or surgery
echocardiography with standard condition (usual)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| echocardiography with postural support then standard condition | Experimental | the first echocardiography (ultrasound) is performed with a postural support then the second echocardiography is performed with standard condition Receives: Procedure: echocardiography with postural support; Procedure: echocardiography with standard condition (usual) |
| echocardiography with standard condition then support postural | Active comparator | the first echocardiography (ultrasounds) is performed with standard condition (usual) and the second echocardiography is performed with a postural support Receives: Procedure: echocardiography with postural support; Procedure: echocardiography with standard condition (usual) |
What is being measured
The primary outcome is the main question the study is designed to answer.
value of the ratio of the acceleration time of pulmonary arterial flow.
for each echocardiography (support condition and postural support)
Measured: up to 1 hour
value of the ejection time of pulmonary arterial flow
for each echocardiography (support condition and postural support)
Measured: up to 1 hour
Secondary outcomes (3)
pain assessment with a clinical scale
assessment of the pain with a practical behavioral observation scale
Measured: up to 1 hour
number of participant with a Patent ductus arteriosus shunt
Measured: up to 2 hours
systolic pulmonary arterial pressure
Measured: up to 2 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startApr 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature NewbornStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02893956
- Sponsor's protocol ID
- 9252
- Status last verified
- Aug 2016
- First submitted
- 21 Jul 2016
- Last updated
- 9 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Postural Support During Echocardiography Modify Hemodynamic Features and Discomfort Induced by the Examination in Very Premature Neonates?
- ClinicalTrials.gov ID
- NCT02893956
- Acronym / sponsor ID
- 9252
- Conditions
- Premature Newborn
- Keywords
- Echocardiography, postural support, preterm neonate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 9 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| echocardiography with postural support then standard condition | Experimental | Procedure: echocardiography with postural support, Procedure: echocardiography with standard condition (usual)the first echocardiography (ultrasound) is performed with a postural support then the second echocardiography is performed with standard condition |
| echocardiography with standard condition then support postural | Active comparator | 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 |
Who may qualify
- Ages
- 1 minute to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| echocardiography with postural support | Procedure or surgery | echocardiography with postural support then standard condition, echocardiography with standard condition then support postural |
| echocardiography with standard condition (usual) | Procedure or surgery | echocardiography with postural support then standard condition, echocardiography with standard condition then support postural |
Primary outcome
value of the ratio of the acceleration time of pulmonary arterial flow.
Time frame: up to 1 hour
for each echocardiography (support condition and postural support)
value of the ejection time of pulmonary arterial flow
Time frame: up to 1 hour
for each echocardiography (support condition and postural support)
3 secondary outcomes
pain assessment with a clinical 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing echocardiography with postural support and echocardiography with standard condition (usual) in people with Premature Newborn, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
value of the ratio of the acceleration time of pulmonary arterial flow. (time frame: up to 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2016.