Adrenomedullin Changes After Sustained Inflation or Positive Pressure Ventilation at Birth

NCT03437499 | Completed DMC

• 1 other identifier: 300
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lung Injury

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Positive Pressure Ventilation

ACTIVE COMPARATOR

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

Procedure: Positive Pressure Ventilation

Sustained Inflation

EXPERIMENTAL

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

Procedure: Sustained Inflation

Interventions

Sustained Inflation PROCEDURE

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

Sustained Inflation

Positive Pressure Ventilation PROCEDURE

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

Positive Pressure Ventilation

Eligibility Criteria

• Age: 28 Weeks - 30 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• gestational age between 28+0 and 30+6
• need for respiratory support in the delivery room

You may not qualify if:

• major malformations (i.e. congenital heart disease, cerebral, lung and abdominal malformations)
• fetal hydrops
• lack of parental consent.
• Need for endotracheal intubation at birth

Sponsors & Collaborators

• Vittore Buzzi Children's Hospital: lead

Related Publications (3)

• 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.

  PMID: 25624390 RESULT

• 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.

  PMID: 8387282 RESULT

• 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.

  PMID: 26196743 RESULT

MeSH Terms

Conditions

Lung Injury

Interventions

Positive-Pressure Respiration

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Thoracic Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Gianluca Lista, MD PhD

  NICU-ASST-FBF-Sacco

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: February 19, 2018
• Study Start: March 1, 2013
• Primary Completion: October 31, 2014
• Study Completion: October 31, 2014
• Last Updated: February 19, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share