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Completed

NCT Number: NCT03411018

Respiratory Management of Preterm Infants and Bronchopulmonary Dysplasia

This observational study evaluates the impact of respiratory management modifications implemented in our institution on the intubation rates and the death or Bronchopulmonary Dysplasia (BPD) outcome.

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Key information

Conditions

Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Respiratory Tract Diseases Urogenital Diseases Ventilator-Induced Lung Injury

Age range

Up to 36 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Cristina Ramos-Navarro

Madrid, 28033, Spain

About this study

Less invasive respiratory management has been implemented in most neonatal units as well as lung protective ventilatory strategies when intubation is required in order to minimize ventilator induced lung injury.

In our institution a new ventilatory protocol including less invasive surfactant administration, Synchronized nasal positive pressure ventilation and early rescue High frequency ventilation has been implemented during 2013-14.

Hypothesis: New less invasive and lung protective strategies to prevent lung injury had been effective in reducing intubation rates.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

All preterm Infants born with less than 32wGA admitted in our NICU.

Exclusion criteria

Congenital malformations and Known Chromosomal disorders,

Treatment and study plan

Mechanical ventilation exposure

Other

Primary outcomes

  1. BRONCHOPULMONARY DySPLASIA

    Time frame: 36 weeks of postmenstrual age.

    Diagnosis of moderate-severe bronchopulmonary dysplasia (physiological definition)

  2. mortality

    Time frame: before discharge

    death

Secondary outcomes

  1. Mechanical ventilation

    Time frame: during hospitalization

    requirement of mechanical ventilation

Sponsors and collaborators

Lead sponsor

Manuel Sanchez Luna

Other

Registry information

Official study title

The Impact of Modifications on Respiratory Management of Preterm Infants on the Death or Bronchopulmonary Dysplasia Outcome

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Jan 25, 2018
Registry last updated
Aug 27, 2021

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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