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Early Neonatal Respiratory Distress: Changes in Level IIb Hospital Over a Period of One Year (DROPE)

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ClinicalTrials.gov Identifier: NCT02824497
Recruitment Status : Completed
First Posted : July 6, 2016
Last Update Posted : July 22, 2016
Sponsor:
Information provided by (Responsible Party):
Groupe Hospitalier Paris Saint Joseph

Brief 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. 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.

Condition or disease Intervention/treatment
Neonatal Respiratory Distress Syndrome Other: No intervention. It's a description study

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.

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Ecologic or Community
Time Perspective: Retrospective
Official Title: Early Neonatal Respiratory Distress: Changes in Level IIb Hospital Over a Period of One Year
Study Start Date : May 2015
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Neonatal data [ Time Frame: Day 0 ]

    Number of Participants With same characteristics for:

    • Gestational Age
    • Birth Weight
    • cord pH
    • Apgar M5

  2. The terms of the allocation: [ Time Frame: Day 0 ]

    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.



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Ages Eligible for Study:   32 Weeks and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02824497


Locations
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France
Groupe Hospitalier Paris Saint Joseph
Paris, Ile-de-France, France, 75014
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
Investigators
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Principal Investigator: WALTER Elisabeth, MD Groupe Hospitalier Paris Saint Joseph
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Responsible Party: Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier: NCT02824497    
Other Study ID Numbers: DETRESSE Respiratoire
First Posted: July 6, 2016    Key Record Dates
Last Update Posted: July 22, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Hyaline Membrane Disease
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases