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

Neonatal Respiratory Distress Syndrome Clinical Trial

— DROPE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02824497
• Other study ID #: DETRESSE Respiratoire
• Status: Completed
• Start date: May 2015
• Est. completion date: May 2015

Study information

• Verified date: June 2016
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Hyaline Membrane Disease
• Neonatal Respiratory Distress Syndrome
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

Other:
• No intervention. It's a description study

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint Joseph	Paris	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

Outcome

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