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Respiratory Management of Preterm Infants and Bronchopulmonary Dysplasia

M

Manuel Sanchez Luna

Status

Completed

Conditions

Bronchopulmonary Dysplasia

Treatments

Other: Mechanical ventilation exposure

Study type

Observational

Funder types

Other

Identifiers

NCT03411018
CEIC 84/17

Details and patient eligibility

About

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.

Full 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.

Enrollment

600 patients

Sex

All

Ages

Under 36 weeks old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Congenital malformations and Known Chromosomal disorders,

Trial design

600 participants in 2 patient groups

Conventional respiratory managed group.
Description:
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
Treatment:
Other: Mechanical ventilation exposure
Less invasive managed group
Description:
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
Treatment:
Other: Mechanical ventilation exposure

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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