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Sustained Lung Inflation and Pulmonary Mechanics in Preterm Infant

Primary Purpose

Preterm Birth, Respiratory Distress Syndrome, Lung Diseases

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sustained lung inflation
mask using a T-piece system (Fabian,Acutronic Medical Systems AG, Switzerland).
Sponsored by
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preterm Birth focused on measuring Respiratory Distress Syndrome, Newborn, Delivery Room, Resuscitation, Premature birth, Infant, Newborn, Respiration Artificial

Eligibility Criteria

25 Weeks - 36 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Gestational age (GA) at least 25 weeks but less than 36 completed weeks by best obstetrical estimate

Exclusion Criteria:

  • Refusal of antenatal informed consent
  • Known major anomalies, pulmonary hypoplasia
  • Severe perinatal suffering

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    SLI group

    Control

    Arm Description

    In this group the preterm infants will receive sustained lung inflation (SLI) with mask in the delivery room; the parameters of respiratory mechanics will be monitored for 5 minutes by means of the forced oscillation technique.

    Preterm infants will be assisted in the delivery room with a continuous positive airway pressure (CPAP) of 5 cmH2O with mask and the parameters of respiratory mechanics will be monitored for 5 minutes by means of the forced oscillation technique.

    Outcomes

    Primary Outcome Measures

    Change in Reactance (Xrs) values measured by the forced oscillation technique (FOT)

    Secondary Outcome Measures

    Need for intubation within the first 72 hours of life
    Duration of respiratory support (ventilation, CPAP, supplemental oxygen)
    Death in hospital
    Number of surfactant doses
    Retinopathy of prematurity (ROP) stage 3 or greater requiring treatment
    Incidence of Patent Ductus Arteriosus (PDA) requiring treatment
    Incidence of Bronchopulmonary dysplasia
    Defined according to the criteria of Jobe and Bancalari (Jobe A, Bancalari E. Bronchopulmonary dysplasia. Am J Respir Crit Care Med 2001;163:1723-9)
    Incidence of Intracranial Hemorrhages (ICH)
    We used the ICH classification of Papile et al
    Length of hospital stay

    Full Information

    First Posted
    June 23, 2015
    Last Updated
    February 26, 2021
    Sponsor
    Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02493920
    Brief Title
    Sustained Lung Inflation and Pulmonary Mechanics in Preterm Infant
    Official Title
    Evaluation of Pulmonary Mechanics in Preterm Infant Treated With Sustained Lung Inflation at Birth
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Technical problems, unreliability of the measured parameters
    Study Start Date
    March 2016 (Anticipated)
    Primary Completion Date
    March 2017 (Anticipated)
    Study Completion Date
    March 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Lung protection should start in the delivery room where, from the first breaths, the preterm infant can be helped to clear the lung fluid and to recruit alveolar spaces and establish the functional residual capacity (FRC). Sustained lung inflation (SLI) applied at birth in the delivery room has been demonstrated to lead to clearance of lung fluid and achievement of a precocious functional residual capacity (FRC) both in animal and human studies. SLI associated to an adequate positive end expiratory pressure (PEEP) may help the efficacy of the respiratory effort in lung of preterm infants at risk for respiratory distress syndrome (RDS) and reduce need of mechanical ventilation (MV). Further studies are required to evaluate the clinical utility of this maneuver. The ability to monitor what happens to the lungs while applying different recruitment maneuvers in preterm infants would allow the definition of a procedure that allows optimal assistance to improve the FRC. One promising approach is provided by the forced oscillation technique (FOT). During forced oscillations, a small amplitude sinusoidal pressure stimulus is applied to the airway opening and the mechanical response of the respiratory system is studied by means of the total respiratory input impedance (Zin). Zin is a complex number that can be expressed as real part, called resistance (Rrs), and imaginary part, called reactance (Xrs). Particularly, it has been recently shown that Xrs measured at 5 Hz is very sensible to changes in the mechanics of lung periphery and provides accurate information about lung volume recruitment and derecruitment. The main purpose of this work is to apply FOT to the assessment of lung function in newborns submitted to SLI at birth. The investigators hypothesized that the application in the delivery room of the SLI in the preterm infant is effective in achieving a greater FRC and therefore a greater value of Xrs compared to a control group not treated with the SLI.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Preterm Birth, Respiratory Distress Syndrome, Lung Diseases
    Keywords
    Respiratory Distress Syndrome, Newborn, Delivery Room, Resuscitation, Premature birth, Infant, Newborn, Respiration Artificial

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    SLI group
    Arm Type
    Experimental
    Arm Description
    In this group the preterm infants will receive sustained lung inflation (SLI) with mask in the delivery room; the parameters of respiratory mechanics will be monitored for 5 minutes by means of the forced oscillation technique.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Preterm infants will be assisted in the delivery room with a continuous positive airway pressure (CPAP) of 5 cmH2O with mask and the parameters of respiratory mechanics will be monitored for 5 minutes by means of the forced oscillation technique.
    Intervention Type
    Other
    Intervention Name(s)
    Sustained lung inflation
    Other Intervention Name(s)
    lung recruitment
    Intervention Description
    Sustained lung inflation (SLI) will be performed with mask using a T-piece system (Fabian,Acutronic Medical Systems AG, Switzerland).Peak inflation pressure (PIP) of 25 cm H2O will be delivered for 15 seconds and then reduced to a PEEP of 5 cm H2O. A second SLI manoeuvre will be repeated in case of persistent hearth failure (HR <100 bpm).
    Intervention Type
    Device
    Intervention Name(s)
    mask using a T-piece system (Fabian,Acutronic Medical Systems AG, Switzerland).
    Primary Outcome Measure Information:
    Title
    Change in Reactance (Xrs) values measured by the forced oscillation technique (FOT)
    Time Frame
    Baseline and at 5 minutes of life (that is, before and at the end of the SLI)
    Secondary Outcome Measure Information:
    Title
    Need for intubation within the first 72 hours of life
    Time Frame
    72 hours of life
    Title
    Duration of respiratory support (ventilation, CPAP, supplemental oxygen)
    Time Frame
    During hospitalization - up to 36 weeks Post Menstrual Age (PMA)
    Title
    Death in hospital
    Time Frame
    During hospitalization - up to 40 weeks Post Menstrual Age (PMA)
    Title
    Number of surfactant doses
    Time Frame
    During hospitalization - up to 36 weeks Post Menstrual Age (PMA)
    Title
    Retinopathy of prematurity (ROP) stage 3 or greater requiring treatment
    Time Frame
    40 weeks Post Menstrual Age (PMA)
    Title
    Incidence of Patent Ductus Arteriosus (PDA) requiring treatment
    Time Frame
    During hospitalization - up to 36 weeks Post Menstrual Age (PMA)
    Title
    Incidence of Bronchopulmonary dysplasia
    Description
    Defined according to the criteria of Jobe and Bancalari (Jobe A, Bancalari E. Bronchopulmonary dysplasia. Am J Respir Crit Care Med 2001;163:1723-9)
    Time Frame
    36 weeks Post Menstrual Age (PMA)
    Title
    Incidence of Intracranial Hemorrhages (ICH)
    Description
    We used the ICH classification of Papile et al
    Time Frame
    During hospitalization- up to 40 weeks Post Menstrual Age (PMA)
    Title
    Length of hospital stay
    Time Frame
    Average discharge between 36 - 40 weeks PMA

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Weeks
    Maximum Age & Unit of Time
    36 Weeks
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Gestational age (GA) at least 25 weeks but less than 36 completed weeks by best obstetrical estimate Exclusion Criteria: Refusal of antenatal informed consent Known major anomalies, pulmonary hypoplasia Severe perinatal suffering
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mariarosa Colnaghi, MD
    Organizational Affiliation
    NICU, IRCCS Cà Granda, Ospedale Maggiore Policlinico, Milan
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Sustained Lung Inflation and Pulmonary Mechanics in Preterm Infant

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