Clinical trial NCT02824497: Early Neonatal Respiratory Distress: Changes in Level IIb Hospital Over a Period of One Year
Official title: Early Neonatal Respiratory Distress: Changes in Level IIb Hospital Over a Period of One Year
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neonatal Respiratory Distress Syndrome
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2016-07-06
Enrollment: 100
Sex: ALL
Minimum age (years): 32
Maximum age (years): 40
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Obstetric data
timeFrame: Day 0
Secondary outcomes:
measure: Neonatal data
timeFrame: Day 0
measure: The terms of the allocation:
timeFrame: Day 0
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: WALTER Elisabeth, MD
role: PRINCIPAL_INVESTIGATOR
References: