Adrenomedullin Changes After Sustained Inflation or Positive Pressure Ventilation at Birth

Not Applicable

Completed

• Conditions: Lung Injury
• Interventions: Procedure: Sustained Inflation; Procedure: Positive Pressure Ventilation

• Registration Number: NCT03437499
• Lead Sponsor: Vittore Buzzi Children's Hospital

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.

Study Timeline

• Study Start: 2013-03-01
• Primary Completion: 2014-10-31
• Study Completion: 2014-10-31
• Status Verified: 2018-02
• Study First Submitted: 2018-02-05
• Study First Submitted QC: 2018-02-12
• Last Update Submitted: 2018-02-12
• Study First Posted: 2018-02-19
• Last Update Posted: 2018-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sustained Inflation	Sustained Inflation	Prolonged inflation ( 25 cmH20 for 15 seconds) followed by PEEP set at 5 cmH2O
Positive Pressure Ventilation	Positive Pressure Ventilation	Positive Pressure Ventilation ( peak pressure set at 25 cmH20 and PEEP set at 5 cmH2O, with 40 inflations per minute)

Primary Outcome Measures

Name	Time	Method
AM levels in plasma and urine in preterm infants with respiratory failure	24 hours	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.