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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03437499
Other study ID # 300
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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