Adrenomedullin Changes After Sustained Inflation or Positive Pressure Ventilation at Birth

Effects of Sustained Inflation or Positive Pressure Ventilation on Release of Adrenomedullin in Preterm Infants With Respiratory Failure at Birth

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03437499

Enrollment

Registered

2018-02-19

Start date

2013-03-01

Completion date

2014-10-31

Last updated

2018-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Injury

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.

Interventions

PROCEDURESustained 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

PROCEDUREPositive Pressure Ventilation

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

28 Weeks to 30 Weeks

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026