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The Impact of Lung Recruitment Maneuver in 24-32 Weekers, and the Incidence of Bronchopulmonary Dysplasia

Primary Purpose

Bronchopulmonary Dysplasia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
lung recruitment maneuver (LRM) with DrageerVN500
Sponsored by
Dr. R. Adhi Teguh Perma Iskandar, Sp.A(K)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bronchopulmonary Dysplasia focused on measuring lung recruitment maneuver, preterm babies, Bronchopulmonary dysplasia

Eligibility Criteria

undefined - 48 Hours (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 24-32 weeks preterm babies.
  • Babies on assist-control volume guarantee ventilation with FiO2 > 30% to reach oxygen saturations within 90-95%.
  • Age less than 48 hours.
  • Born in Cipto Mangunkusumo Hospital and Bunda Menteng Hospital.
  • Parents/guardians agreed to participate in this study with sign informed consent.

Exclusion Criteria:

  • Weight birth <750 grams.
  • APGAR score at 10 minutes are <5.
  • Born with congenital heart disease except patent ductus arteriosus or presistence foramen ovale.
  • Born with congenital disorder that need surgery intervention (for example :

diaphragmatic hernia, atresia ani, esophageal atresia, duodenal atresia.

  • Born with congenital disorder that worsening of the respiratory distress (for example

    • hydrops fetalis, phrenic nerve paralysis, abnormality of chest wall, abnormality of air way (for example : Choanal atresia, Laryngeal stenosis, cleft palate.
  • Born inborn error metabolism disease.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    lung recruitment maneuver (LRM) group

    without lung recruitment maneuver (LRM) group

    Arm Description

    The lung recruitment maneuver (LRM) will be done by increasing of PEEP 0,2 cm H2O every 3 minutes, until reach the opening pressure. After that PEEP decrease gradually until get the closing pressure. Than the investigators will back to the opening pressure for 3 minutes, and the final PEEP will be put backo 0,2 above closing pressure.

    Another group get standart protocol only.

    Outcomes

    Primary Outcome Measures

    Knowing the relationship between lung recruitment maneuver in 24-32 weeks preterm babies with the incidence of Bronchopulmonary dysplasia
    Preterm babies ( 24-32 weeks) with Lung Recruitment maneuver will have lower incidence of Bronchopulmonary dysplasia compare to control.

    Secondary Outcome Measures

    Knowing the relationship between lung recruitment maneuver in 24-32 weekers, with their alveolar intergrity (serum levels of surfactan protein-D)
    Preterm babies ( 24-32 weeks) with Lung Recruitment maneuver will have lower serum levels of surfactan protein -D compare to control.
    Knowing the relationship between lung recruitment maneuver in 24-32 weekers, with their lung endothel intergrity (serum levels of CD-31+)
    Preterm babies ( 24-32 weeks) with Lung Recruitment maneuver will have lower serum concentrarion of CD-31+ compare to control.
    Knowing the relationship between lung recruitment maneuver in 24-32 weeks preterm babies with their lung endothel intergrity (serum levels of CD-42b-)
    Preterm babies ( 24-32 weeks) with Lung Recruitment maneuver will have lower serum concentrarion of CD-42b- compare to control.
    Knowing the relationship between lung recruitment maneuver in 24-32 weeks preterm babies with their micro circulation (oxygen index)
    Preterm babies ( 24-32 weeks) with Lung Recruitment maneuver will have higher oxygen index compare to control.
    Knowing the relationship between lung recruitment maneuver in 24-32 weeks preterm babies with their their micro circulation (tc-pCO2 - PaCO2 index)
    preterm babies ( 24-32 weeks) with Lung Recrutment manuver will have transcutaneous-arterial partial carbon dioxide gap lower than control ( less than 6 mmHg ). babies with better microcirculation status will show less than 6 mmHg transcutaneous-arterial partial carbon dioxide gap.
    Knowing the relationship between lung recruitment maneuver in 24-32 weeks preterm babies with their incidence patent ductus arteriosus (PDA) significant
    Preterm babies ( 24-32 weeks) with Lung Recruitment maneuver will make lower incident of Patent Ductus Arteriosus compare to control.
    Knowing the relationship between lung recruitment maneuver in 24-32 weeks preterm babies with their macro circulation
    Preterm babies ( 24-32 weeks) with Lung Recruitment maneuver will make right and left cardiac output higher compare to control.

    Full Information

    First Posted
    August 12, 2020
    Last Updated
    September 14, 2020
    Sponsor
    Dr. R. Adhi Teguh Perma Iskandar, Sp.A(K)
    Collaborators
    Indonesian Medical Education and Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04555889
    Brief Title
    The Impact of Lung Recruitment Maneuver in 24-32 Weekers, and the Incidence of Bronchopulmonary Dysplasia
    Official Title
    The Impact of Lung Recruitment Maneuver in 24-32 Weeks Preterm Babies With Assist-control Volume Guarantee Mode to Their Hemodynamic Status and the Incidence of Bronchopulmonary Dysplasia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 31, 2020 (Anticipated)
    Primary Completion Date
    October 31, 2022 (Anticipated)
    Study Completion Date
    December 30, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Dr. R. Adhi Teguh Perma Iskandar, Sp.A(K)
    Collaborators
    Indonesian Medical Education and Research Institute

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    hypothesis : The incident of dysplasia bronchopulmonary and/or death in 24-32 weekers babies on assist-control volume guarantee ventilation are lower in lung recruitment maneuver (LRM) group compare to control. The serum levels of surfactant protein-D in 24-32 weekers babies on assist-control volume guarantee ventilation are lower in lung recruitment maneuver (LRM) group compare to control. The serum concentration of CD-31+ and CD-42b- in 24-32 weekers babies on assist-control volume guarantee ventilation are lower in lung recruitment maneuver (LRM) group compare to control. The right and left cardiac output in 24-32 weekers babies on assist-control volume guarantee mode are more higher in lung recruitment maneuver (LRM) group, than group that did not get LRM The incident Patent Ductus Arteriosus in 24-32 weekers babies on assist-control volume guarantee ventilation are lower in lung recruitment maneuver (LRM) group compare to control. The difference tc-pCO2 - PaCO2 , tcO2 index , and strong ion difference (SID) in 24-32 weekers babies on assist-control volume guarantee ventilation are lower in lung recruitment maneuver (LRM) group compare to control.
    Detailed Description
    description of the protocol : All Babies that meet inclusion criteria would immediately given surfactan. Babies will do echocardiography, blood gas analize, blood sample, transcutaneous monitor. After that babies will be randomized, the intervention group will get standart protocol + lung recruitment maneuver (LRM) and another group get standart protocol only. The lung recruitment maneuver (LRM) will be done by increasing of PEEP 0,2 cm H2O every 3 minutes, until reach the opening pressure. After that PEEP decrease gradually until get the closing pressure. Than the investigators will back to the opening pressure for 3 minutes, and the final PEEP will be put back 0,2 above closing pressure. After 3rd days (72 hours) babies, the investigators will exime serum levels of surfactan protein-D, CD-31+ and CD-42b- , blood gas , tc-pCO2 - PaCO2 , tcO2 index. After that babies will observe within 28 days to detect Bronchopulmonary dysplasia

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bronchopulmonary Dysplasia
    Keywords
    lung recruitment maneuver, preterm babies, Bronchopulmonary dysplasia

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The impact of lung recruitment maneuver in 24-32 weekers with assist-control volume guarantee mode to their hemodynamic status and the incidence of Bronchopulmonary dysplasia
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    All babies wether they experience the intervention ofr not they can not tell to other peoples. Only The lab analyzer will be blind to the subject of study, other measurement can not be blind.
    Allocation
    Randomized
    Enrollment
    110 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    lung recruitment maneuver (LRM) group
    Arm Type
    Experimental
    Arm Description
    The lung recruitment maneuver (LRM) will be done by increasing of PEEP 0,2 cm H2O every 3 minutes, until reach the opening pressure. After that PEEP decrease gradually until get the closing pressure. Than the investigators will back to the opening pressure for 3 minutes, and the final PEEP will be put backo 0,2 above closing pressure.
    Arm Title
    without lung recruitment maneuver (LRM) group
    Arm Type
    No Intervention
    Arm Description
    Another group get standart protocol only.
    Intervention Type
    Device
    Intervention Name(s)
    lung recruitment maneuver (LRM) with DrageerVN500
    Intervention Description
    interventions involving device that may help to gradually lung development
    Primary Outcome Measure Information:
    Title
    Knowing the relationship between lung recruitment maneuver in 24-32 weeks preterm babies with the incidence of Bronchopulmonary dysplasia
    Description
    Preterm babies ( 24-32 weeks) with Lung Recruitment maneuver will have lower incidence of Bronchopulmonary dysplasia compare to control.
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Knowing the relationship between lung recruitment maneuver in 24-32 weekers, with their alveolar intergrity (serum levels of surfactan protein-D)
    Description
    Preterm babies ( 24-32 weeks) with Lung Recruitment maneuver will have lower serum levels of surfactan protein -D compare to control.
    Time Frame
    12 weeks
    Title
    Knowing the relationship between lung recruitment maneuver in 24-32 weekers, with their lung endothel intergrity (serum levels of CD-31+)
    Description
    Preterm babies ( 24-32 weeks) with Lung Recruitment maneuver will have lower serum concentrarion of CD-31+ compare to control.
    Time Frame
    12 weeks
    Title
    Knowing the relationship between lung recruitment maneuver in 24-32 weeks preterm babies with their lung endothel intergrity (serum levels of CD-42b-)
    Description
    Preterm babies ( 24-32 weeks) with Lung Recruitment maneuver will have lower serum concentrarion of CD-42b- compare to control.
    Time Frame
    12 weeks
    Title
    Knowing the relationship between lung recruitment maneuver in 24-32 weeks preterm babies with their micro circulation (oxygen index)
    Description
    Preterm babies ( 24-32 weeks) with Lung Recruitment maneuver will have higher oxygen index compare to control.
    Time Frame
    12 weeks
    Title
    Knowing the relationship between lung recruitment maneuver in 24-32 weeks preterm babies with their their micro circulation (tc-pCO2 - PaCO2 index)
    Description
    preterm babies ( 24-32 weeks) with Lung Recrutment manuver will have transcutaneous-arterial partial carbon dioxide gap lower than control ( less than 6 mmHg ). babies with better microcirculation status will show less than 6 mmHg transcutaneous-arterial partial carbon dioxide gap.
    Time Frame
    12 weeks
    Title
    Knowing the relationship between lung recruitment maneuver in 24-32 weeks preterm babies with their incidence patent ductus arteriosus (PDA) significant
    Description
    Preterm babies ( 24-32 weeks) with Lung Recruitment maneuver will make lower incident of Patent Ductus Arteriosus compare to control.
    Time Frame
    12 weeks
    Title
    Knowing the relationship between lung recruitment maneuver in 24-32 weeks preterm babies with their macro circulation
    Description
    Preterm babies ( 24-32 weeks) with Lung Recruitment maneuver will make right and left cardiac output higher compare to control.
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    48 Hours
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 24-32 weeks preterm babies. Babies on assist-control volume guarantee ventilation with FiO2 > 30% to reach oxygen saturations within 90-95%. Age less than 48 hours. Born in Cipto Mangunkusumo Hospital and Bunda Menteng Hospital. Parents/guardians agreed to participate in this study with sign informed consent. Exclusion Criteria: Weight birth <750 grams. APGAR score at 10 minutes are <5. Born with congenital heart disease except patent ductus arteriosus or presistence foramen ovale. Born with congenital disorder that need surgery intervention (for example : diaphragmatic hernia, atresia ani, esophageal atresia, duodenal atresia. Born with congenital disorder that worsening of the respiratory distress (for example hydrops fetalis, phrenic nerve paralysis, abnormality of chest wall, abnormality of air way (for example : Choanal atresia, Laryngeal stenosis, cleft palate. Born inborn error metabolism disease.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dr. R. Adhi T Perma Iskandar, Sp.A (K)
    Phone
    +62 85779153162
    Email
    adhitpi@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    DR.Dr. Risma K Kaban, Sp.A (K)
    Phone
    +62 816902051
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dr. R. Adhi T Perma Iskandar, Sp.A (K)
    Organizational Affiliation
    RSCMPerinatology
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    Heated, humidified high-flow nasal cannula vs. nasal CPAP in infants with moderate respiratory distress
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    Experimental Ventilator-induced Lung Injury: Exacerbation by Positive End-Expiratory Pressure
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    Transitional Hemodynamics in Preterm Neonates: Clinical Relevance
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    Description
    Bronchopulmonary dysplasia: risk prediction models for very-lowbirth-weight infants

    Learn more about this trial

    The Impact of Lung Recruitment Maneuver in 24-32 Weekers, and the Incidence of Bronchopulmonary Dysplasia

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