Neonatal Respiratory Distress SyndromeDROPENCT02824497
Early Neonatal Respiratory Distress: Changes in Level IIb Hospital Over a Period of One Year
An observational study of Neonatal Respiratory Distress Syndrome, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Respiratory distress is one of the first hospital grounds during the neonatal period. The clinical presentation and severity vary by gestational age and cause. She reports to various etiological factors as maternal, neonatal or sometimes entangled. Read more about this study
- Who is it for?
- Ages 32 to 40 weeks
- Conditions the study is for
- Neonatal Respiratory Distress Syndrome
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- May 2015to May 2015
- 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 32 to 40 weeks
- All sexes
- No healthy volunteers
- Child
Study population: infants 32 weeks gestation or older with early and persistent respiratory distress to 2 hours of life (H2) over a period of one year, to a type IIb motherhood.
Who may be able to join
- Gestational Age (A) ≥ 32 SA
- Birth weight (PN) ≥ 1000 g
- Respiratory distress appeared in the first 2 of life and non-limiting in H2.
Who cannot join
- AG <32 SA
- PN <1000g
- Malformation diagnosed ante or immediate postpartum justifying a specific urgent care.
- Respiratory distress appeared before H2 and H2-limited before, whatever the company therapeutic.
- Respiratory distress appeared after H2.
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
Respiratory distress is one of the first hospital grounds during the neonatal period. The clinical presentation and severity vary by gestational age and cause. She reports to various etiological factors as maternal, neonatal or sometimes entangled. The symptomatic management has benefited from organizational progress (perinatal care) and techniques, including antenatal steroids, the use of exogenous surfactant and non-invasive ventilation early, so that the use of intubation is less frequent. The short-term evolution of patients with early respiratory distress is based on gestational age, cause and initial management.
Read the detailed description
Main objective:
To describe the care and short-term respiratory become newborns 32 weeks gestation or older with early and persistent respiratory distress to 2 hours of life (H2) over a period of one year in a type IIb motherhood.
Methodology :
Design: retrospective, descriptive, single-center, non-interventional
Performed in the Saint Joseph neonatal unit. Study duration: 1 year (01/05/2013-04/30/2014).
Acquisition of data:
The patients were selected from the hospitalization reports of infants by taking the following key words: respiratory distress, invasive and noninvasive ventilation, intubation, exogenous surfactant, pneumothorax.
Data collected:
- Obstetric data:
- Mode of delivery: route of delivery, presentation at birth.
- Maternal morbidity.
- antenatal corticosteroids in infants less than 34 weeks.
- Neonatal data:
- Gestational Age
- Birth Weight
- cord pH
- Apgar M5
- The terms of the allocation:
- Tracheal Intubation
- ventilation modes (controlled mechanical ventilation (VMC), non-invasive ventilation (NIV), nasal cannula), the maximum reached FiO2 (fraction of inspired oxygen), ventilation time for each ventilation mode. These different methods were studied in the delivery room during hospitalization (in intensive care and neonatal intensive care "NICU").
- The place of hospitalization: resuscitation and / or NICU.
- The transfer to the NICU resuscitation if necessary.
- Received drugs (exogenous surfactant, antibiotics, caffeine)
- The successful primary diagnosis.
- Conditions
- Neonatal Respiratory Distress Syndrome
- Being tested
- No intervention. It's a description study
- Medical subject headings
- Respiratory Distress Syndrome, Newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention. It's a description studyOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Obstetric data
Number of Participants With same characteristics for:
- Mode of delivery: route of delivery, presentation at birth.
- Maternal morbidity.
- antenatal corticosteroids in infants less than 34 weeks.
Measured: Day 0
Secondary outcomes (2)
Neonatal data
Number of Participants With same characteristics for:
- Gestational Age
- Birth Weight
- cord pH
- Apgar M5
Measured: Day 0
The terms of the allocation:
Number of Participants With same characteristics for:
- Tracheal Intubation
- ventilation modes (controlled mechanical ventilation (VMC), non-invasive ventilation (NIV), nasal cannula), the maximum reached FiO2, ventilation time for each ventilation mode. These different methods were studied in the delivery room during hospitalization (in intensive care and neonatal intensive care "NICU")
- The place of hospitalization: resuscitation and / or NICU.
- The transfer to the NICU resuscitation if necessary.
- Received drugs (exogenous surfactant, antibiotics, caffeine)
- The successful primary diagnosis.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study startMay 2015
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Respiratory Distress SyndromeStudies of the same condition, open and under way.
- 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
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- WALTER Elisabeth, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02824497
- Sponsor's protocol ID
- DETRESSE Respiratoire
- Acronym
- DROPE
- Status last verified
- Jun 2016
- First submitted
- 29 Jun 2016
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Neonatal Respiratory Distress: Changes in Level IIb Hospital Over a Period of One Year
- ClinicalTrials.gov ID
- NCT02824497
- Acronym / sponsor ID
- DROPE / DETRESSE Respiratoire
- Conditions
- Neonatal Respiratory Distress Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 6 Jul 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.
Respiratory distress is one of the first hospital grounds during the neonatal period. The clinical presentation and severity vary by gestational age and cause. She reports to various etiological factors as maternal, neonatal or sometimes entangled. The symptomatic management has benefited from organizational progress (perinatal care) and techniques, including antenatal steroids, the use of exogenous surfactant and non-invasive ventilation early, so that the use of intubation is less frequent. The short-term evolution of patients with early respiratory distress is based on gestational age, cause and initial management.
Detailed description
Main objective:
To describe the care and short-term respiratory become newborns 32 weeks gestation or older with early and persistent respiratory distress to 2 hours of life (H2) over a period of one year in a type IIb motherhood.
Methodology :
Design: retrospective, descriptive, single-center, non-interventional
Performed in the Saint Joseph neonatal unit. Study duration: 1 year (01/05/2013-04/30/2014).
Acquisition of data:
The patients were selected from the hospitalization reports of infants by taking the following key words: respiratory distress, invasive and noninvasive ventilation, intubation, exogenous surfactant, pneumothorax.
Data collected:
- Obstetric data:
- Mode of delivery: route of delivery, presentation at birth.
- Maternal morbidity.
- antenatal corticosteroids in infants less than 34 weeks.
- Neonatal data:
- Gestational Age
- Birth Weight
- cord pH
- Apgar M5
- The terms of the allocation:
- Tracheal Intubation
- ventilation modes (controlled mechanical ventilation (VMC), non-invasive ventilation (NIV), nasal cannula), the maximum reached FiO2 (fraction of inspired oxygen), ventilation time for each ventilation mode. These different methods were studied in the delivery room during hospitalization (in intensive care and neonatal intensive care "NICU").
- The place of hospitalization: resuscitation and / or NICU.
- The transfer to the NICU resuscitation if necessary.
- Received drugs (exogenous surfactant, antibiotics, caffeine)
- The successful primary diagnosis.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
Who may qualify
- Ages
- 32 to 40 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- infants 32 weeks gestation or older with early and persistent respiratory distress to 2 hours of life (H2) over a period of one year, to a type IIb motherhood.
Key inclusion criteria (3 listed)
- Gestational Age (A) ≥ 32 SA
- Birth weight (PN) ≥ 1000 g
- Respiratory distress appeared in the first 2 of life and non-limiting in H2.
Key exclusion criteria (5 listed)
- AG <32 SA
- PN <1000g
- Malformation diagnosed ante or immediate postpartum justifying a specific urgent care.
- Respiratory distress appeared before H2 and H2-limited before, whatever the company therapeutic.
- Respiratory distress appeared after H2.
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 |
|---|---|---|
| No intervention. It's a description study | Other | – |
Primary outcome
Obstetric data
Time frame: Day 0
Number of Participants With same characteristics for: * Mode of delivery: route of delivery, presentation at birth. * Maternal morbidity. * antenatal corticosteroids in infants less than 34 weeks.
2 secondary outcomes
Neonatal data
Time frame: Day 0
The terms of the allocation:
Time frame: Day 0
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 27 Apr 2023.
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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.
WALTER Elisabeth, MD principal investigator
Fondation Hôpital Saint-Joseph
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 Syndrome, run by Fondation Hôpital Saint-Joseph 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 5 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 27 Apr 2023. 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?
Obstetric data (time frame: Day 0). 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 27 Apr 2023.