Respiratory Management of Preterm Infants and Bronchopulmonary Dysplasia

NCT03411018 | Completed DMC

• 1 other identifier: CEIC 84/17
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchopulmonary Dysplasia

Keywords

lung protective strategies; Less invasive respiratory support; preterm infant

Outcome Measures

Primary Outcomes (2)

• BRONCHOPULMONARY DySPLASIA

  Diagnosis of moderate-severe bronchopulmonary dysplasia (physiological definition)

  36 weeks of postmenstrual age.

• mortality

  death

  before discharge

Secondary Outcomes (1)

• Mechanical ventilation

  during hospitalization

Study Arms (2)

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

Other: Mechanical ventilation exposure

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

Other: Mechanical ventilation exposure

Interventions

Mechanical ventilation exposure OTHER

Conventional respiratory managed group.; Less invasive managed group

Eligibility Criteria

• Age: Up to 36 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All preterm infant born with less than 32wGA since January 2012 to December 2017 admitted in our NICU.

You may qualify if:

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

You may not qualify if:

• Congenital malformations and Known Chromosomal disorders,

Sponsors & Collaborators

• Manuel Sanchez Luna: lead

Study Sites (1)

Cristina Ramos-Navarro

Madrid, 28033, Spain

Location

MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Premature Birth

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Cristina Ramos-Navarro

  Gregorio Marañon, Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Neonatology, Clinical Professor

Study Record Dates

• First Submitted: January 19, 2018
• First Posted: January 25, 2018
• Study Start: January 1, 2012
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: August 27, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)