Medium vs Low Oxygen Threshold for the Surfactant Administration

NCT04199364 | Unknown Phase 4

• 2 other identifiers: 25352019-002923-13
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Respiratory Distress Syndrome

Keywords

RDS; Surfactant; Threshold; Oxygen; Preterm; Infant

Outcome Measures

Primary Outcomes (1)

• Respiratory pulmonary function

  The oxygen saturation (SpO2) to fraction of inspired oxygen (FiO2) ratio (SFR)

  At day 3 of life

Secondary Outcomes (9)

• Endotracheal intubation

  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

  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

  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

  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

  At day 3, 7 and 28 of life, and at 36 weeks of postmenstrual age or at the discharge if it occurs first

Study Arms (2)

Low FiO2 threshold

EXPERIMENTAL

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

Medium FiO2 threshold

EXPERIMENTAL

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

Interventions

Poractant Alfa 80 mg/mL Intratracheal Suspension DRUG

Exogenous surfactant (Poractant Alfa) administration at a dose of 200 mg/kg.

Low FiO2 threshold; Medium FiO2 threshold

Eligibility Criteria

• Age: 24 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Virgilio Paolo Carnielli: lead

Related Publications (19)

• Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Te Pas A, Plavka R, Roehr CC, Saugstad OD, Simeoni U, Speer CP, Vento M, Visser GHA, Halliday HL. European Consensus Guidelines on the Management of Respiratory Distress Syndrome - 2019 Update. Neonatology. 2019;115(4):432-450. doi: 10.1159/000499361. Epub 2019 Apr 11.

  PMID: 30974433 BACKGROUND

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  PMID: 8441430 BACKGROUND

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  PMID: 27365307 BACKGROUND

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  PMID: 23595061 BACKGROUND

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  PMID: 22150698 BACKGROUND

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  PMID: 22935774 BACKGROUND

• Gulczynska E, Szczapa T, Hozejowski R, Borszewska-Kornacka MK, Rutkowska M. Fraction of Inspired Oxygen as a Predictor of CPAP Failure in Preterm Infants with Respiratory Distress Syndrome: A Prospective Multicenter Study. Neonatology. 2019;116(2):171-178. doi: 10.1159/000499674. Epub 2019 May 21.

  PMID: 31112987 BACKGROUND

• Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Plavka R, Saugstad OD, Simeoni U, Speer CP, Vento M, Visser GH, Halliday HL. European Consensus Guidelines on the Management of Respiratory Distress Syndrome - 2016 Update. Neonatology. 2017;111(2):107-125. doi: 10.1159/000448985. Epub 2016 Sep 21.

  PMID: 27649091 BACKGROUND

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  PMID: 23359726 BACKGROUND

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• Narendran V, Donovan EF, Hoath SB, Akinbi HT, Steichen JJ, Jobe AH. Early bubble CPAP and outcomes in ELBW preterm infants. J Perinatol. 2003 Apr-May;23(3):195-9. doi: 10.1038/sj.jp.7210904.

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• Pang H, Zhang B, Shi J, Zang J, Qiu L. Diagnostic value of lung ultrasound in evaluating the severity of neonatal respiratory distress syndrome. Eur J Radiol. 2019 Jul;116:186-191. doi: 10.1016/j.ejrad.2019.05.004. Epub 2019 May 7.

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• Trachsel D, McCrindle BW, Nakagawa S, Bohn D. Oxygenation index predicts outcome in children with acute hypoxemic respiratory failure. Am J Respir Crit Care Med. 2005 Jul 15;172(2):206-11. doi: 10.1164/rccm.200405-625OC. Epub 2005 Apr 7.

  PMID: 15817802 BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome; Premature Birth

Interventions

poractant alfa

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Virgilio Carnielli, MD, PHD

CONTACT

0715962045; v.carnielli@staff.univpm.it

Valentina Dell'Orto, MD

CONTACT

0715962014; valentinagiovanna.dellorto@ospedaliriuniti.marche.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Neonatology

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: December 13, 2019
• Study Start: June 1, 2021
• Primary Completion: July 1, 2024
• Study Completion: April 30, 2025
• Last Updated: April 19, 2021

Record last verified: 2021-04