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

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.

Study Overview

• Status: Completed
• Conditions: Lung Injury
• Intervention / Treatment: Procedure: Positive Pressure Ventilation; Procedure: Sustained Inflation

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 Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Positive Pressure Ventilation; Positive Pressure Ventilation ( peak pressure set at 25 cmH20 and PEEP set at 5 cmH2O, with 40 inflations per minute)	Procedure: Positive 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
Experimental: Sustained Inflation; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hours

Collaborators and Investigators

• Sponsor: Vittore Buzzi Children's Hospital
• Investigators: Study Chair: Gianluca Lista, MD PhD, NICU-ASST-FBF-Sacco

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2013
• Primary Completion (Actual): October 31, 2014
• Study Completion (Actual): October 31, 2014

Study Registration Dates

• First Submitted: February 5, 2018
• First Submitted That Met QC Criteria: February 12, 2018
• First Posted (Actual): February 19, 2018

Study Record Updates

• Last Update Posted (Actual): February 19, 2018
• Last Update Submitted That Met QC Criteria: February 12, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Wounds and Injuries; Thoracic Injuries; Lung Injury
• Other Study ID Numbers: 300

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No