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

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.

Study Overview

• Status: Completed
• Conditions: Neonatal Respiratory Distress Syndrome
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• France
  • Ile-de-France
    • Paris, Ile-de-France, France, 75014
      • Groupe hospitalier Paris saint Joseph

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 months and older (Child)
• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal data	Number of Participants With same characteristics for: Gestational Age; Birth Weight; cord pH; Apgar M5	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.	Day 0

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Paris Saint Joseph
• Investigators: Principal Investigator: WALTER Elisabeth, MD, Groupe hospitalier Paris saint Joseph

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: June 29, 2016
• First Submitted That Met QC Criteria: July 1, 2016
• First Posted (Estimate): July 6, 2016

Study Record Updates

• Last Update Posted (Actual): April 27, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Hyaline Membrane Disease
• Other Study ID Numbers: DETRESSE Respiratoire