Sustained Lung Inflation and Pulmonary Mechanics in Preterm Infant

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Lung Diseases; Preterm Birth; Respiratory Distress Syndrome
• Intervention / Treatment: Other: Sustained lung inflation; Device: mask using a T-piece system (Fabian,Acutronic Medical Systems AG, Switzerland).

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 8 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SLI group; In this group the preterm infants will receive sustained lung inflation (SLI) with mask in the delivery room; the parameters of respiratory mechanics will be monitored for 5 minutes by means of the forced oscillation technique.	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).; Other Names: lung recruitment; Device: mask using a T-piece system (Fabian,Acutronic Medical Systems AG, Switzerland).
No Intervention: Control; Preterm infants will be assisted in the delivery room with a continuous positive airway pressure (CPAP) of 5 cmH2O with mask and the parameters of respiratory mechanics will be monitored for 5 minutes by means of the forced oscillation technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for intubation within the first 72 hours of life		72 hours of life
Duration of respiratory support (ventilation, CPAP, supplemental oxygen)		During hospitalization - up to 36 weeks Post Menstrual Age (PMA)
Death in hospital		During hospitalization - up to 40 weeks Post Menstrual Age (PMA)
Number of surfactant doses		During hospitalization - up to 36 weeks Post Menstrual Age (PMA)
Retinopathy of prematurity (ROP) stage 3 or greater requiring treatment		40 weeks Post Menstrual Age (PMA)
Incidence of Patent Ductus Arteriosus (PDA) requiring treatment		During hospitalization - up to 36 weeks Post Menstrual Age (PMA)
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)
Incidence of Intracranial Hemorrhages (ICH)	We used the ICH classification of Papile et al	During hospitalization- up to 40 weeks Post Menstrual Age (PMA)
Length of hospital stay		Average discharge between 36 - 40 weeks PMA

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Investigators: Principal Investigator: Mariarosa Colnaghi, MD, NICU, IRCCS Cà Granda, Ospedale Maggiore Policlinico, Milan

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2016
• Primary Completion (Anticipated): March 1, 2017
• Study Completion (Anticipated): March 1, 2018

Study Registration Dates

• First Submitted: June 23, 2015
• First Submitted That Met QC Criteria: July 9, 2015
• First Posted (Estimate): July 10, 2015

Study Record Updates

• Last Update Posted (Actual): March 2, 2021
• Last Update Submitted That Met QC Criteria: February 26, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Infant, Newborn; Premature birth; Resuscitation; Respiratory Distress Syndrome, Newborn; Delivery Room; Respiration Artificial
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Infant, Newborn, Diseases; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Infant, Premature, Diseases; Lung Diseases; Premature Birth; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: MECCANICA SLI