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

NCT ID: NCT02824497

Last Updated: 2023-04-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2015-05-31

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.

Conditions

Neonatal Respiratory Distress Syndrome

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: RETROSPECTIVE

Interventions

No intervention. It's a description study

Intervention Type: OTHER

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.

• Minimum Eligible Age: 32 Weeks
• Maximum Eligible Age: 40 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Hôpital Saint-Joseph

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

WALTER Elisabeth, MD

Role: PRINCIPAL_INVESTIGATOR

Fondation Hôpital Saint-Joseph

Locations

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, France

Countries

France

Other Identifiers

DETRESSE Respiratoire

Identifier Type: -

Identifier Source: org_study_id