Respiratory Management of Preterm Infants and Bronchopulmonary Dysplasia

August 23, 2021 updated by: Manuel Sanchez Luna

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28033
        • Cristina Ramos-Navarro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 8 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

Congenital malformations and Known Chromosomal disorders,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Manuel Sanchez Luna

Investigators

  • Principal Investigator: Cristina Ramos-Navarro, Gregorio Marañon, Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2012

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

January 19, 2018

First Submitted That Met QC Criteria

January 24, 2018

First Posted (Actual)

January 25, 2018

Study Record Updates

Last Update Posted (Actual)

August 27, 2021

Last Update Submitted That Met QC Criteria

August 23, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEIC 84/17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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