Sustained Lung Inflation and Pulmonary Mechanics in Preterm Infant

Lung Diseases Clinical Trial

Official title:

Evaluation of Pulmonary Mechanics in Preterm Infant Treated With Sustained Lung Inflation at Birth

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02493920
• Other study ID #: MECCANICA SLI
• Status: Withdrawn
• Phase: N/A
• Start date: March 2016
• Est. completion date: March 2018

Study information

• Verified date: February 2021
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Lung protection should start in the delivery room where, from the first breaths, the preterm infant can be helped to clear the lung fluid and to recruit alveolar spaces and establish the functional residual capacity (FRC). Sustained lung inflation (SLI) applied at birth in the delivery room has been demonstrated to lead to clearance of lung fluid and achievement of a precocious functional residual capacity (FRC) both in animal and human studies. SLI associated to an adequate positive end expiratory pressure (PEEP) may help the efficacy of the respiratory effort in lung of preterm infants at risk for respiratory distress syndrome (RDS) and reduce need of mechanical ventilation (MV).

Further studies are required to evaluate the clinical utility of this maneuver. The ability to monitor what happens to the lungs while applying different recruitment maneuvers in preterm infants would allow the definition of a procedure that allows optimal assistance to improve the FRC. One promising approach is provided by the forced oscillation technique (FOT). During forced oscillations, a small amplitude sinusoidal pressure stimulus is applied to the airway opening and the mechanical response of the respiratory system is studied by means of the total respiratory input impedance (Zin). Zin is a complex number that can be expressed as real part, called resistance (Rrs), and imaginary part, called reactance (Xrs). Particularly, it has been recently shown that Xrs measured at 5 Hz is very sensible to changes in the mechanics of lung periphery and provides accurate information about lung volume recruitment and derecruitment. The main purpose of this work is to apply FOT to the assessment of lung function in newborns submitted to SLI at birth. The investigators hypothesized that the application in the delivery room of the SLI in the preterm infant is effective in achieving a greater FRC and therefore a greater value of Xrs compared to a control group not treated with the SLI.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2018
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Weeks to 36 Weeks

Eligibility

Inclusion Criteria:

• Gestational age (GA) at least 25 weeks but less than 36 completed weeks by best obstetrical estimate

Exclusion Criteria:

• Refusal of antenatal informed consent

• Known major anomalies, pulmonary hypoplasia

• Severe perinatal suffering

Related Conditions & MeSH terms

• Lung Diseases
• Premature Birth
• Preterm Birth
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Other:
• Sustained lung inflation
Sustained lung inflation (SLI) will be performed with mask using a T-piece system (Fabian,Acutronic Medical Systems AG, Switzerland).Peak inflation pressure (PIP) of 25 cm H2O will be delivered for 15 seconds and then reduced to a PEEP of 5 cm H2O. A second SLI manoeuvre will be repeated in case of persistent hearth failure (HR <100 bpm).

Device:
• mask using a T-piece system (Fabian,Acutronic Medical Systems AG, Switzerland).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Reactance (Xrs) values measured by the forced oscillation technique (FOT)		Baseline and at 5 minutes of life (that is, before and at the end of the SLI)
Secondary	Need for intubation within the first 72 hours of life		72 hours of life
Secondary	Duration of respiratory support (ventilation, CPAP, supplemental oxygen)		During hospitalization - up to 36 weeks Post Menstrual Age (PMA)
Secondary	Death in hospital		During hospitalization - up to 40 weeks Post Menstrual Age (PMA)
Secondary	Number of surfactant doses		During hospitalization - up to 36 weeks Post Menstrual Age (PMA)
Secondary	Retinopathy of prematurity (ROP) stage 3 or greater requiring treatment		40 weeks Post Menstrual Age (PMA)
Secondary	Incidence of Patent Ductus Arteriosus (PDA) requiring treatment		During hospitalization - up to 36 weeks Post Menstrual Age (PMA)
Secondary	Incidence of Bronchopulmonary dysplasia	Defined according to the criteria of Jobe and Bancalari (Jobe A, Bancalari E. Bronchopulmonary dysplasia. Am J Respir Crit Care Med 2001;163:1723-9)	36 weeks Post Menstrual Age (PMA)
Secondary	Incidence of Intracranial Hemorrhages (ICH)	We used the ICH classification of Papile et al	During hospitalization- up to 40 weeks Post Menstrual Age (PMA)
Secondary	Length of hospital stay		Average discharge between 36 - 40 weeks PMA