Adrenomedullin Changes After Sustained Inflation or Positive Pressure Ventilation at Birth

Lung Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03437499
• Other study ID #: 300
• Status: Completed
• Phase: N/A
• First received: February 5, 2018
• Last updated: February 12, 2018
• Start date: March 1, 2013
• Est. completion date: October 31, 2014

Study information

• Verified date: February 2018
• Source: Vittore Buzzi Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: October 31, 2014
• Est. primary completion date: October 31, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 28 Weeks to 30 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Lung Injury

Intervention

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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vittore Buzzi Children's Hospital

References & Publications (3)

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. — View Citation

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 inf — View Citation

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):1048-53. doi: 10.1016/j.bbrc.2015.07.067. Epub 2015 Jul — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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