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Clinical Trials/NCT02824497
NCT02824497
Completed
Not Applicable

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

Fondation Hôpital Saint-Joseph1 site in 1 country100 target enrollmentMay 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neonatal Respiratory Distress Syndrome
Sponsor
Fondation Hôpital Saint-Joseph
Enrollment
100
Locations
1
Primary Endpoint
Obstetric data
Status
Completed
Last Updated
3 years ago

Overview

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 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.

Registry
clinicaltrials.gov
Start Date
May 2015
End Date
May 2015
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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.

Outcomes

Primary Outcomes

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 Outcomes

  • The terms of the allocation:(Day 0)
  • Neonatal data(Day 0)

Study Sites (1)

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