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

NCT02824497 | Completed DMC

• 1 other identifier: DETRESSE Respiratoire
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Neonatal data

  Day 0

• The terms of the allocation:

  Day 0

Interventions

No intervention. It's a description study OTHER

Eligibility Criteria

• Age: 32 Weeks - 40 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Gestational Age (A) ≥ 32 SA
• Birth weight (PN) ≥ 1000 g
• Respiratory distress appeared in the first 2 of life and non-limiting in H2.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome, Newborn

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• WALTER Elisabeth, MD

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2016
• First Posted: July 6, 2016
• Study Start: May 1, 2015
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: April 27, 2023

Record last verified: 2016-06

Locations

FR (1)