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Adrenomedullin Changes After Sustained Inflation or Positive Pressure Ventilation at Birth

Primary Purpose

Lung Injury

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sustained Inflation
Positive Pressure Ventilation
Sponsored by
Vittore Buzzi Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Injury

Eligibility Criteria

28 Weeks - 30 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • gestational age between 28+0 and 30+6
  • need for respiratory support in the delivery room

Exclusion Criteria:

  • major malformations (i.e. congenital heart disease, cerebral, lung and abdominal malformations)
  • fetal hydrops
  • lack of parental consent.
  • Need for endotracheal intubation at birth

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Positive Pressure Ventilation

    Sustained Inflation

    Arm Description

    Positive Pressure Ventilation ( peak pressure set at 25 cmH20 and PEEP set at 5 cmH2O, with 40 inflations per minute)

    Prolonged inflation ( 25 cmH20 for 15 seconds) followed by PEEP set at 5 cmH2O

    Outcomes

    Primary Outcome Measures

    AM levels in plasma and urine in preterm infants with respiratory failure
    to investigate, in a cohort of preterm infants with respiratory failure at birth, the short-term AM release (plasma and urine samples at different time-points) after initial resuscitation with SI or PPV.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 5, 2018
    Last Updated
    February 12, 2018
    Sponsor
    Vittore Buzzi Children's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03437499
    Brief Title
    Adrenomedullin Changes After Sustained Inflation or Positive Pressure Ventilation at Birth
    Official Title
    Effects of Sustained Inflation or Positive Pressure Ventilation on Release of Adrenomedullin in Preterm Infants With Respiratory Failure at Birth
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    March 1, 2013 (Actual)
    Primary Completion Date
    October 31, 2014 (Actual)
    Study Completion Date
    October 31, 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Vittore Buzzi Children's Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    In this clinical trial the Investigators aimed to assess the Adrenomedullin (AM) release in urine and plasma in preterm infants undergoing Sustained Inflation or Positive Pressure Ventilation at birth to manage respiratory failure.
    Detailed Description
    Background and objectives: The respiratory management in the DR may play an important role in the development and prevention of lung injury. The sustained lung inflation (SI) is a promising approach to facilitate cardio-respiratory transition, but currently, although it has been shown to decrease the duration of MV, seems not to guarantee relevant benefits compared to Positive Pressure Ventilation (PPV). In order to clarify the impact of these two different approaches on lung tissues, this study measures Adrenomedullin (AM), which is a biomarker involved in lung development. Methods: we conducted a prospective case control-study in a cohort of very low birth weight (VLBW) infants (< 1500 g) of 28+0-30+6 weeks of gestational age (GA), who received SI or PPV during stabilization in DR. Exclusion criteria were major malformations (i.e. congenital heart disease, cerebral, lung and abdominal malformations), fetal hydrops, lack of parental consent and need for endotracheal intubation at birth. Blood samples for AM measurement were collected at birth from the arterial umbilical cord before resuscitation maneuvers, then at 1 hour from birth and at 24 hours from birth. Moreover, urine samples were collected, in correspondence with the first urine emission while in NICU and at 24 hours of life.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lung Injury

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Positive Pressure Ventilation
    Arm Type
    Active Comparator
    Arm Description
    Positive Pressure Ventilation ( peak pressure set at 25 cmH20 and PEEP set at 5 cmH2O, with 40 inflations per minute)
    Arm Title
    Sustained Inflation
    Arm Type
    Experimental
    Arm Description
    Prolonged inflation ( 25 cmH20 for 15 seconds) followed by PEEP set at 5 cmH2O
    Intervention Type
    Procedure
    Intervention Name(s)
    Sustained Inflation
    Intervention Description
    Application of positive pressure by face mask with T-piece resuscitator for a prolonged period of 15 seconds at a peak pressure of 25 cmH20 followed by PEEP set at 5 cmH2O
    Intervention Type
    Procedure
    Intervention Name(s)
    Positive Pressure Ventilation
    Intervention Description
    Application of positive pressure by face mask with T-piece resuscitator at a peak pressure of 25 cmH20, PEEP set at 5 cmH2, for 40 inflations/minute
    Primary Outcome Measure Information:
    Title
    AM levels in plasma and urine in preterm infants with respiratory failure
    Description
    to investigate, in a cohort of preterm infants with respiratory failure at birth, the short-term AM release (plasma and urine samples at different time-points) after initial resuscitation with SI or PPV.
    Time Frame
    24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    28 Weeks
    Maximum Age & Unit of Time
    30 Weeks
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: gestational age between 28+0 and 30+6 need for respiratory support in the delivery room Exclusion Criteria: major malformations (i.e. congenital heart disease, cerebral, lung and abdominal malformations) fetal hydrops lack of parental consent. Need for endotracheal intubation at birth
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gianluca Lista, MD PhD
    Organizational Affiliation
    NICU-ASST-FBF-Sacco
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    25624390
    Citation
    Lista G, Boni L, Scopesi F, Mosca F, Trevisanuto D, Messner H, Vento G, Magaldi R, Del Vecchio A, Agosti M, Gizzi C, Sandri F, Biban P, Bellettato M, Gazzolo D, Boldrini A, Dani C; SLI Trial Investigators. Sustained lung inflation at birth for preterm infants: a randomized clinical trial. Pediatrics. 2015 Feb;135(2):e457-64. doi: 10.1542/peds.2014-1692.
    Results Reference
    result
    PubMed Identifier
    8387282
    Citation
    Kitamura K, Kangawa K, Kawamoto M, Ichiki Y, Nakamura S, Matsuo H, Eto T. Adrenomedullin: a novel hypotensive peptide isolated from human pheochromocytoma. Biochem Biophys Res Commun. 1993 Apr 30;192(2):553-60. doi: 10.1006/bbrc.1993.1451.
    Results Reference
    result
    PubMed Identifier
    26196743
    Citation
    Zhang S, Patel A, Moorthy B, Shivanna B. Adrenomedullin deficiency potentiates hyperoxic injury in fetal human pulmonary microvascular endothelial cells. Biochem Biophys Res Commun. 2015 Sep 4;464(4):1048-1053. doi: 10.1016/j.bbrc.2015.07.067. Epub 2015 Jul 18.
    Results Reference
    result

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    Adrenomedullin Changes After Sustained Inflation or Positive Pressure Ventilation at Birth

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