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Completed

NCT Number: NCT02824497

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

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.

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Key information

Age range

32 week–40 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupe Hospitalier Paris Saint Joseph

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention. It's a description study

Other

Primary outcomes

  1. Obstetric data

    Time frame: Day 0

    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.

Secondary outcomes

  1. Neonatal data

    Time frame: Day 0

    Number of Participants With same characteristics for:

    • Gestational Age
    • Birth Weight
    • cord pH
    • Apgar M5
  2. The terms of the allocation:

    Time frame: Day 0

    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.

Sponsors and collaborators

Lead sponsor

Fondation Hôpital Saint-Joseph

Other

Registry information

Acronym: DROPE

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 6, 2016
Registry last updated
Apr 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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