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Clinical Trials/NCT03411018
NCT03411018CompletedNot Applicable

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

Manuel Sanchez Luna1 site in 1 country600 target enrollmentStarted: January 1, 2012Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
600
Locations
1
Primary Endpoint
BRONCHOPULMONARY DySPLASIA

Study Overview

Brief 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.

Detailed 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
— to 36 Weeks (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Congenital malformations and Known Chromosomal disorders,

Outcomes

Primary Outcomes

BRONCHOPULMONARY DySPLASIA

Time Frame: 36 weeks of postmenstrual age.

Diagnosis of moderate-severe bronchopulmonary dysplasia (physiological definition)

mortality

Time Frame: before discharge

death

Secondary Outcomes

  • Mechanical ventilation(during hospitalization)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Manuel Sanchez Luna

Head of Neonatology, Clinical Professor

Hospital General Universitario Gregorio Marañon

Study Sites (1)

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