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NCT03411018 Clinical Trial

Respiratory Management of Preterm Infants and Bronchopulmonary Dysplasia

Bronchopulmonary Dysplasia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03411018
Other study ID # CEIC 84/17
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2012
Est. completion date December 31, 2017

Study information
Verified date August 2021
Source Hospital General Universitario Gregorio Marañon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 600
Est. completion date December 31, 2017
Est. primary completion date December 31, 2017
Accepts healthy volunteers No
Gender All
Age group N/A to 36 Weeks
Eligibility Inclusion Criteria: All preterm Infants born with less than 32wGA admitted in our NICU. Exclusion Criteria: Congenital malformations and Known Chromosomal disorders,

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Mechanical ventilation exposure

Locations
Country Name City State
Spain Cristina Ramos-Navarro Madrid

Sponsors (1)
Lead Sponsor Collaborator
Manuel Sanchez Luna

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary BRONCHOPULMONARY DySPLASIA Diagnosis of moderate-severe bronchopulmonary dysplasia (physiological definition) 36 weeks of postmenstrual age.
Primary mortality death before discharge
Secondary Mechanical ventilation requirement of mechanical ventilation during hospitalization
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