An interventional study of Sustained Inflation and Positive Pressure Ventilation in Lung Injury, sponsored by Vittore Buzzi Children's Hospital. Completed. Open to participants aged 28 Weeks to 30 Weeks. Per ClinicalTrials.gov, last updated 2018-02-19.
Sponsored by Vittore Buzzi Children's Hospital · Not applicable, Interventional, and Diagnostic
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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.
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.
114 studies on the registry are indexed under Lung Injury; 33 are open to participants now.
This study's enrollment of 45 is below the median of 62 across 75 interventional studies indexed under Lung Injury.
Browse Lung Injury studies →Vittore Buzzi Children's Hospital is the lead sponsor of 10 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Positive Pressure Ventilation ( peak pressure set at 25 cmH20 and PEEP set at 5 cmH2O, with 40 inflations per minute)
Procedure: Positive Pressure Ventilation
Prolonged inflation ( 25 cmH20 for 15 seconds) followed by PEEP set at 5 cmH2O
Procedure: Sustained Inflation
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
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
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.
Time frame: 24 hours
No study locations are listed for this record.
Plan to share: No
Ran from Mar 2013 to primary completion in Oct 2014, 19 months.
Of 28 interventional studies with no phase under Lung Injury, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 69. This study's 19 months is below that.
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This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Vittore Buzzi Children's Hospital