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Medium vs Low Oxygen Threshold for the Surfactant Administration

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ClinicalTrials.gov Identifier: NCT04199364
Recruitment Status : Not yet recruiting
First Posted : December 13, 2019
Last Update Posted : September 3, 2020
Sponsor:
Information provided by (Responsible Party):
Virgilio Paolo Carnielli, Ospedali Riuniti Ancona

Brief Summary:
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 30% 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.

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome Drug: Poractant Alfa 80 mg/mL Intratracheal Suspension Phase 4

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 30% 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Participants will be masked.
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : November 1, 2020
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : October 31, 2024


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.




Primary Outcome Measures :
  1. Respiratory pulmonary function [ Time Frame: At day 3 of life ]
    The oxygen saturation (SpO2) to fraction of inspired oxygen (FiO2) ratio (SFR)


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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)

  8. 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

  9. In-hospital death [ Time Frame: From birth to 36 week of gestation or discharge if it occurred first ]
    death before 36 weeks of gestation



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Ages Eligible for Study:   24 Weeks to 32 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04199364


Contacts
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Contact: Virgilio Carnielli, MD, PHD 0715962045 v.carnielli@staff.univpm.it
Contact: Valentina Dell'Orto, MD 0715962014 valentinagiovanna.dellorto@ospedaliriuniti.marche.it

Sponsors and Collaborators
Virgilio Paolo Carnielli
Publications:

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Responsible Party: Virgilio Paolo Carnielli, Director of Neonatology, Ospedali Riuniti Ancona
ClinicalTrials.gov Identifier: NCT04199364    
Other Study ID Numbers: 2535
2019-002923-13 ( EudraCT Number )
First Posted: December 13, 2019    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Virgilio Paolo Carnielli, Ospedali Riuniti Ancona:
RDS
Surfactant
Threshold
Oxygen
Preterm
Infant
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Poractant alfa
Pulmonary Surfactants
Respiratory System Agents