Medium vs Low Oxygen Threshold for the Surfactant Administration

April 15, 2021 updated by: Virgilio Paolo Carnielli

Comparison of Two Fraction Oxygen Inspired (FiO2) Thresholds for the Surfactant Administration in Preterm Infants With Respiratory Disease Syndrome: a Single-center Randomized Phase IV Clinical Trial

The aim of this study will be to assess the better fraction inspired oxygen (FiO2) threshold for the surfactant treatment in preterm infants with respiratory distress syndrome (RDS) randomized to receive exogenous surfactant at 25% or 35% of FiO2 threshold. The pulmonary gas-exchanges will be evaluated by oxygen saturation (SpO2) to FiO2 ratio (SFR) and will be used to define the better FiO2 threshold for the surfactant treatment.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Exogenous surfactant therapy is an effective treatment of neonatal respiratory distress syndrome (RDS) and has been associated with reduced severity of respiratory distress and mortality. The 2019 European guidelines for neonatal RDS treatment suggest as the threshold of inspired oxygen (FiO2) for the surfactant treatment at 30% for all gestational age, but there are no randomized studies that confirm this indication. Some observational studies reported that a relevant number of patients who are not routinely treated with surfactant had respiratory complications, thus they received exogenous surfactant. To date, the optimal FiO2 threshold for surfactant administration remains unclear.

In this single-center, randomized, phase 4 trial, preterm infants (gestational age<32 weeks) with RDS will be randomized to receive exogenous surfactant at 25% or 35% of FiO2 threshold. According to the unit policy, the exogenous surfactant will be administered by an endotracheal tube in intubated infants, or by Intubation-Surfactant-Extubation (InSurE) / Less Invasive Surfactant Administration (LISA) methods in infants who will not remain intubated. The method used for the surfactant administration will be at the discretion of the caring physician.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 7 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • gestational age less than 32 weeks;
  • diagnosis of respiratory distress (RDS);
  • need for ventilatory support;
  • written informed consent.

Exclusion Criteria:

  • congenital malformations;
  • genetic disorders;
  • perinatal asphyxia.
  • neonatal pneumonia or wet lung or meconium aspiration syndrome at birth.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low FiO2 threshold
A fraction of inspired oxygen (FiO2) of 25% to have an oxygen saturation (SpO2) of 90-92%.
Drug: Poractant Alfa 80 mg/mL Intratracheal Suspension
Exogenous surfactant (Poractant Alfa) administration at a dose of 200 mg/kg.
Experimental: Medium FiO2 threshold
A fraction of inspired oxygen (FiO2) of 35% to have an oxygen saturation (SpO2) of 90-92%.
Drug: Poractant Alfa 80 mg/mL Intratracheal Suspension
Exogenous surfactant (Poractant Alfa) administration at a dose of 200 mg/kg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory pulmonary function
Time Frame: At day 3 of life
The oxygen saturation (SpO2) to fraction of inspired oxygen (FiO2) ratio (SFR)
At day 3 of life

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endotracheal intubation
Time Frame: At day 3, 7 and 28 of life, and at 36 weeks of postmenstrual age or at the discharge if it occurs first
The need of endotracheal intubation after surfactant administration
At day 3, 7 and 28 of life, and at 36 weeks of postmenstrual age or at the discharge if it occurs first
Oxygen therapy
Time Frame: At day 3, 7 and 28 of life, and at 36 weeks of postmenstrual age or at the discharge if it occurs first
The need of oxygen therapy
At day 3, 7 and 28 of life, and at 36 weeks of postmenstrual age or at the discharge if it occurs first
Respiratory Support-1
Time Frame: At day 3, 7 and 28 of life, and at 36 weeks of postmenstrual age or at the discharge if it occurs first
The need of respiratory support
At day 3, 7 and 28 of life, and at 36 weeks of postmenstrual age or at the discharge if it occurs first
Respiratory Support-1
Time Frame: At day 3, 7 and 28 of life, and at 36 weeks of postmenstrual age or at the discharge if it occurs first
Oxygenation index as indicator of the intensity of ventilatory
At day 3, 7 and 28 of life, and at 36 weeks of postmenstrual age or at the discharge if it occurs first
Respiratory severity-1
Time Frame: At day 3, 7 and 28 of life, and at 36 weeks of postmenstrual age or at the discharge if it occurs first
Silvermann score as secondary respiratory severity index
At day 3, 7 and 28 of life, and at 36 weeks of postmenstrual age or at the discharge if it occurs first
Respiratory severity-2
Time Frame: At day 3, 7 and 28 of life, and at 36 weeks of postmenstrual age or at the discharge if it occurs first
Lung ultrasound score (LUS) score as secondary respiratory severity index
At day 3, 7 and 28 of life, and at 36 weeks of postmenstrual age or at the discharge if it occurs first
Long-term respiratory pulmonary function
Time Frame: At day 7 and 28 of life, and at 36 weeks of postmenstrual age or at the discharge if it occurs first, and 1 year of corrected age
The oxygen saturation (SpO2) to fraction of inspired oxygen (FiO2) ratio (SFR)
At day 7 and 28 of life, and at 36 weeks of postmenstrual age or at the discharge if it occurs first, and 1 year of corrected age
Complications of prematurity
Time Frame: From birth to 36 weeks of postmenstrual age or discharge if it occurred first
The incidence of intraventricular hemorrhage of grade 3-4, periventricular leukomalacia, bronchopulmonary dysplasia, sepsis and retinopathy of prematurity
From birth to 36 weeks of postmenstrual age or discharge if it occurred first
In-hospital death
Time Frame: From birth to 36 week of gestation or discharge if it occurred first
death before 36 weeks of gestation
From birth to 36 week of gestation or discharge if it occurred first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virgilio Paolo Carnielli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2021

Primary Completion (Anticipated)

July 1, 2024

Study Completion (Anticipated)

April 30, 2025

Study Registration Dates

First Submitted

December 12, 2019

First Submitted That Met QC Criteria

December 12, 2019

First Posted (Actual)

December 13, 2019

Study Record Updates

Last Update Posted (Actual)

April 19, 2021

Last Update Submitted That Met QC Criteria

April 15, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2535
  • 2019-002923-13 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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