Neonatal Respiratory DistressREchoPPNCT05737095
Study of the Feasibility of Early Lung Ultrasound in Neonatal Respiratory Distress in Premature Newborns Born Between 32 Weeks of Amenorrhea and 36 Weeks Plus 6 Days of Amenorrhea, Hospitalized in the Neonatal Pediatrics and Intensive Care Units of the Dijon University Hospital
An observational study of Neonatal Respiratory Distress and Preterm Birth, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Monocentric study carried out in the Neonatal and Intensive Care Units of the Dijon University Hospital. The objective is to evaluate the feasibility of performing a pulmonary ultrasound within 6 hours after admission in premature infants born between 32 weeks of amenorrhea and 36 weeks of amenorrhea + 6 days who are… Read more about this study
- Who is it for?
- Ages 0 to 2 hours
- Conditions the study is for
- Neonatal Respiratory Distress, Preterm Birth
- What is being tested?
- Pulmonary ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 69 participants
- Where
- 1 siteFrance
- Study dates
- 27 Nov 2022to 20 Dec 2024
- Phase
- Observational
- 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 0 to 2 hours
- All sexes
- No healthy volunteers
- Child
Study population: Premature infants
Who may be able to join
- Verbal consent from at least one legal guardian
- Premature infant (between 32 weeks of amenorrhea and 36 weeks of amenorrhea + 6 days) admitted for neonatal respiratory distress that began in the first 2 hours of life
- Hospitalized at the Dijon University Hospital in the Neonatal Pediatrics and Intensive Care Units
Who cannot join
- individual is not affiliated to the national health care system
- major intrathoracic or abdominal malformation
Trial locations and contacts
1 site in 1 country.
About this study
Monocentric study carried out in the Neonatal and Intensive Care Units of the Dijon University Hospital.
The objective is to evaluate the feasibility of performing a pulmonary ultrasound within 6 hours after admission in premature infants born between 32 weeks of amenorrhea and 36 weeks of amenorrhea + 6 days who are hospitalized for initial respiratory distress.
Pulmonary ultrasound is performed within 6 hours of admission and an ultrasound score is calculated according to the images observed.
Continued management according to protocols without taking into account the ultrasound data.
Follow-up of patients until discharge from hospital or D28 of life (whichever comes first)
- Conditions
- Neonatal Respiratory Distress, Preterm Birth
- Being tested
- Pulmonary ultrasound
- Medical subject headings
- Pulmonary Atelectasis, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary ultrasoundProcedure or surgery
Within 6 hours of admission to Neonatal Pediatrics and Intensive Care
| Study group | Role | What they receive |
|---|---|---|
| Premature infants | premature infants born between 32 and 36 weeks of amenorrhea + 6 days hospitalized for respiratory distress Receives: Procedure: Pulmonary ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of infants receiving a lung ultrasound within 6 hours of admission divided by the number of infants meeting the inclusion criteria
Number of infants receiving a lung ultrasound within 6 hours of admission divided by the number of infants meeting the inclusion criteria
Measured: Within 6 hours of admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start27 Nov 2022
- Primary completion20 Dec 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Respiratory DistressStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05737095
- Sponsor's protocol ID
- TERNOY-LANZINI 2022
- Acronym
- REchoPP
- Status last verified
- Feb 2025
- First submitted
- 8 Feb 2023
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Feasibility of Early Lung Ultrasound in Neonatal Respiratory Distress in Premature Newborns Born Between 32 Weeks of Amenorrhea and 36 Weeks Plus 6 Days of Amenorrhea, Hospitalized in the Neonatal Pediatrics and Intensive Care Units of the Dijon University Hospital
- ClinicalTrials.gov ID
- NCT05737095
- Acronym / sponsor ID
- REchoPP / TERNOY-LANZINI 2022
- Conditions
- Neonatal Respiratory Distress, Preterm Birth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 27 Nov 2022 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 21 Feb 2023 (actual)
- 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.
Monocentric study carried out in the Neonatal and Intensive Care Units of the Dijon University Hospital.
The objective is to evaluate the feasibility of performing a pulmonary ultrasound within 6 hours after admission in premature infants born between 32 weeks of amenorrhea and 36 weeks of amenorrhea + 6 days who are hospitalized for initial respiratory distress.
Pulmonary ultrasound is performed within 6 hours of admission and an ultrasound score is calculated according to the images observed.
Continued management according to protocols without taking into account the ultrasound data.
Follow-up of patients until discharge from hospital or D28 of life (whichever comes first)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Premature infants | – | Procedure: Pulmonary ultrasoundpremature infants born between 32 and 36 weeks of amenorrhea + 6 days hospitalized for respiratory distress |
Who may qualify
- Ages
- 0 to 2 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Premature infants
Key inclusion criteria (3 listed)
- Verbal consent from at least one legal guardian
- Premature infant (between 32 weeks of amenorrhea and 36 weeks of amenorrhea + 6 days) admitted for neonatal respiratory distress that began in the first 2 hours of life
- Hospitalized at the Dijon University Hospital in the Neonatal Pediatrics and Intensive Care Units
Key exclusion criteria (2 listed)
- individual is not affiliated to the national health care system
- major intrathoracic or abdominal malformation
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 |
|---|---|---|
| Pulmonary ultrasoundWithin 6 hours of admission to Neonatal Pediatrics and Intensive Care | Procedure or surgery | Premature infants |
Primary outcome
Number of infants receiving a lung ultrasound within 6 hours of admission divided by the number of infants meeting the inclusion criteria
Time frame: Within 6 hours of admission
Number of infants receiving a lung ultrasound within 6 hours of admission divided by the number of infants meeting the inclusion criteria
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 24 Feb 2025.
- 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?
An observational study of Neonatal Respiratory Distress and Preterm Birth, run by Centre Hospitalier Universitaire Dijon 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 3 inclusion and 2 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 24 Feb 2025. 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?
Number of infants receiving a lung ultrasound within 6 hours of admission divided by the number of infants meeting the inclusion criteria (time frame: Within 6 hours of admission). 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 24 Feb 2025.