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
About this trial
This is an interventional diagnostic trial for Lung Injury
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
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
NCT ID
NCT03437499
First Posted
February 5, 2018
Last Updated
February 12, 2018
Sponsor
Vittore Buzzi Children's Hospital
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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