Adrenomedullin Changes After Sustained Inflation or Positive Pressure Ventilation at Birth

Vittore Buzzi Children's Hospital

Status: Completed

Conditions: Lung Injury

Treatments: Procedure: Sustained Inflation; Procedure: Positive Pressure Ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT03437499

300

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 28 to 30 weeks old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

Positive Pressure Ventilation

Active Comparator group

Description:

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

Treatment:

Procedure: Positive Pressure Ventilation

Sustained Inflation

Experimental group

Description:

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

Treatment:

Procedure: Sustained Inflation