Clinical Trial: Early Neonatal Respiratory Distress: Changes in Level IIb Hospital Over a Period of One Year

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Early Neonatal Respiratory Distress: Changes in Level IIb Hospital Over a Period of One Year

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.

Detailed Summary:

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:

      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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Neonatal data [ Time Frame: Day 0 ]

    Number of Participants With same characteristics for:

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


Original Secondary Outcome: Same as current

Information By: Groupe Hospitalier Paris Saint Joseph

Dates:
Date Received: June 29, 2016
Date Started: May 2015
Date Completion:
Last Updated: July 21, 2016
Last Verified: June 2016