Respiratory Management of Preterm Infants and 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.

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

Conditions
-----------------
Bronchopulmonary Dysplasia

Intervention / Treatment
-----------------
* Other: Mechanical ventilation exposure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All preterm Infants born with less than 32wGA admitted in our NICU. Exclusion Criteria: Congenital malformations and Known Chromosomal disorders,

Ages Eligible for Study
-----------------
Maximum Age: 36 Weeks

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Conventional respiratory managed group.<br>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 | Other: Mechanical ventilation exposure<br> <br> |
| Less invasive managed group<br>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 | Other: Mechanical ventilation exposure<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BRONCHOPULMONARY DySPLASIA | Diagnosis of moderate-severe bronchopulmonary dysplasia (physiological definition) | 36 weeks of postmenstrual age. | 
| mortality | death | before discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mechanical ventilation | requirement of mechanical ventilation | during hospitalization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lung protective strategies, Less invasive respiratory support, preterm infant