Clinical trial NCT02493920: Sustained Lung Inflation and Pulmonary Mechanics in Preterm Infant
Official title: Evaluation of Pulmonary Mechanics in Preterm Infant Treated With Sustained Lung Inflation at Birth
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Preterm Birth
Respiratory Distress Syndrome
Lung Diseases
Keywords: Respiratory Distress Syndrome, Newborn
Delivery Room
Resuscitation
Premature birth
Infant, Newborn
Respiration Artificial
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2015-07-10
Enrollment: 0
Sex: ALL
Minimum age (years): 25
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Reactance (Xrs) values measured by the forced oscillation technique (FOT)
timeFrame: Baseline and at 5 minutes of life (that is, before and at the end of the SLI)
Secondary outcomes:
measure: Need for intubation within the first 72 hours of life
timeFrame: 72 hours of life
measure: Duration of respiratory support (ventilation, CPAP, supplemental oxygen)
timeFrame: During hospitalization - up to 36 weeks Post Menstrual Age (PMA)
measure: Death in hospital
timeFrame: During hospitalization - up to 40 weeks Post Menstrual Age (PMA)
measure: Number of surfactant doses
timeFrame: During hospitalization - up to 36 weeks Post Menstrual Age (PMA)
measure: Retinopathy of prematurity (ROP) stage 3 or greater requiring treatment
timeFrame: 40 weeks Post Menstrual Age (PMA)
measure: Incidence of Patent Ductus Arteriosus (PDA) requiring treatment
timeFrame: During hospitalization - up to 36 weeks Post Menstrual Age (PMA)
measure: Incidence of Bronchopulmonary dysplasia
timeFrame: 36 weeks Post Menstrual Age (PMA)
measure: Incidence of Intracranial Hemorrhages (ICH)
timeFrame: During hospitalization- up to 40 weeks Post Menstrual Age (PMA)
measure: Length of hospital stay
timeFrame: Average discharge between 36 - 40 weeks PMA
Other outcomes:
Locations:
Study officials:
affiliation: NICU, IRCCS Cà Granda, Ospedale Maggiore Policlinico, Milan
name: Mariarosa Colnaghi, MD
role: PRINCIPAL_INVESTIGATOR
References: