Respiratory Management of Preterm Infants and Bronchopulmonary Dysplasia

Completed

• Conditions: Bronchopulmonary Dysplasia
• Interventions: Other: Mechanical ventilation exposure

• Registration Number: NCT03411018
• Lead Sponsor: Manuel Sanchez Luna

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 Timeline

• Study Start: 2012-01-01
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Study First Submitted: 2018-01-19
• Study First Submitted QC: 2018-01-24
• Study First Posted: 2018-01-25
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-23
• Last Update Posted: 2021-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

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

Exclusion Criteria

Congenital malformations and Known Chromosomal disorders,

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Conventional respiratory managed group.	Mechanical ventilation exposure	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
Less invasive managed group	Mechanical ventilation exposure	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

Primary Outcome Measures

Name	Time	Method
BRONCHOPULMONARY DySPLASIA	36 weeks of postmenstrual age.	Diagnosis of moderate-severe bronchopulmonary dysplasia (physiological definition)
mortality	before discharge	death

Secondary Outcome Measures

Name	Time	Method
Mechanical ventilation	during hospitalization	requirement of mechanical ventilation

Trial Locations

Locations (1)

Cristina Ramos-Navarro; 🇪🇸 Madrid, Spain