Neonatal Respiratory Distress Syndrome Clinical Trial
— DROPEOfficial title:
Early Neonatal Respiratory Distress: Changes in Level IIb Hospital Over a Period of One Year
NCT number | NCT02824497 |
Other study ID # | DETRESSE Respiratoire |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 2015 |
Est. completion date | May 2015 |
Verified date | June 2016 |
Source | Groupe Hospitalier Paris Saint Joseph |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | May 2015 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 32 Weeks to 40 Weeks |
Eligibility | Inclusion Criteria: - Gestational Age (A) = 32 SA - Birth weight (PN) = 1000 g - Respiratory distress appeared in the first 2 of life and non-limiting in H2. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
France | Groupe Hospitalier Paris Saint Joseph | Paris | Ile-de-France |
Lead Sponsor | Collaborator |
---|---|
Groupe Hospitalier Paris Saint Joseph |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
Day 0 | |
Secondary | Neonatal data | Number of Participants With same characteristics for:
Gestational Age Birth Weight cord pH Apgar M5 |
Day 0 | |
Secondary | 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. |
Day 0 |
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