Respiratory Management of Preterm Infants and Bronchopulmonary Dysplasia

NCT ID: NCT03411018

Last Updated: 2021-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-01

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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Bronchopulmonary Dysplasia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Conventional respiratory managed group.

Preterm infants born with less than 32 weeks gestational age (wGA) that entered in the neonatal Intensive care unit (NICU) from January 1 2012 to December 31 2013. These preterm infants were managed according to prior ventilatory protocol: Prophylactic Continuous positive airway pressure (CPAP) in delivery room, early surfactant administration by INSURE technique and volume target mechanical ventilation with rescue high frequency ventilation when needed. Mechanical ventilation exposure will be analyzed

Mechanical ventilation exposure

Intervention Type OTHER

Less invasive managed group

Preterm Infants born with less than 32wGA that entered the NICU from January 1 2014 to December 31 2017. This infants are managed according to the actual ventilatory protocol. Prophylactic CPAP in delivery room, early surfactant administration by less invasive technique, nasal Synchronized positive pressure ventilation for CPAP failure and early rescue high frequency ventilation with minimally target volume.Mechanical ventilation exposure will be analyzed

Mechanical ventilation exposure

Intervention Type OTHER

Interventions

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Mechanical ventilation exposure

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

Congenital malformations and Known Chromosomal disorders,
Maximum Eligible Age

36 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Manuel Sanchez Luna

OTHER

Sponsor Role lead

Responsible Party

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Manuel Sanchez Luna

Head of Neonatology, Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Cristina Ramos-Navarro

Role: PRINCIPAL_INVESTIGATOR

Gregorio MaraƱon, Hospital

Locations

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Cristina Ramos-Navarro

Madrid, , Spain

Site Status

Countries

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Spain

Other Identifiers

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CEIC 84/17

Identifier Type: -

Identifier Source: org_study_id

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