Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

Mechanika układu oddechowego do dostarczania zindywidualizowanego egzogennego środka powierzchniowo czynnego (REMEDIES)

2 listopada 2026 zaktualizowane przez: Anna Lavizzari, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Randomizowana, kontrolowana próba mechaniki oscylacyjnej w porównaniu z kryteriami opartymi na utlenianiu dla terapii środkami powierzchniowo czynnymi

This study is an interventional, non-pharmacological, multicentric, randomized, controlled, superiority, non-profit study. Its primary objective is to evaluate if the administration of surfactant based on FOT assessment will allow a 5-day reduction in the duration of respiratory support as compared to standard practice in preterm infants between 27+0 and 32+6 weeks' gestation. The secondary objectives are:

  1. to determine if a lung mechanics-based approach for administering surfactant will change treatment timing; and
  2. to assess the impact of the novel approach on other neonatal general outcomes. The study will take place within the neonatal intensive care units. Non-invasive respiratory support will be delivered by nasal CPAP with a starting pressure of 5-8 cmH2O. FiO2 will be titrated in order to achieve the target SpO2 91-95%.

Infants matching the clinical criteria for inclusion will be randomized in two arms following the current data protection and confidentiality regulations. Central, computer-generated randomization (allocation 1:1) with variable block sizes according to gestational age will be used. Infants will be stratified according to gestational age (27+0 -28+6 weeks; 29+0 -30+6 weeks; 31+0 -32+6 weeks) and center.

Study Arms:

A) Surfactant administration following oxygenation-based criteria (clinical assessment) (control) B) Surfactant administration following both lung mechanics assessment OR oxygenation-based criteria (clinical assessment) (intervention).

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

458

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Włochy
      • Milan, Włochy
        • Rekrutacyjny
        • Fondazione IRCCs Cà Granda Ospedale Maggiore Policlinico
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

6 miesięcy do 7 miesięcy (Dziecko)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  1. Gestational age (GA) ≥ 27+0 and < 33+0 weeks
  2. Spontaneously breathing infants, requiring non-invasive respiratory support (nasal CPAP or bilevel nasal CPAP). Criteria for commencement of non-invasive respiratory support: FiO2 >0.30 for target SpO2 88-93% or Silverman score ≥ 5.
  3. Inborn
  4. Written parental consent obtained
  5. Administration of Caffeine bolus 20 mg/kg IV or PO as per standard care

Exclusion Criteria:

  1. Major congenital anomalies
  2. Need of intubation in delivery suite according to the AAP guidelines for neonatal resuscitation or early at the admission in NICU (within one hour from birth).
  3. Surfactant therapy prior to the study entry
  4. Severe birth asphyxia, defined by APGAR score ≤ 5 at 10 minutes after birth OR continued need for resuscitation 10 minutes after birth OR pH < 7.0 or base excess (BE) < -12 mmol/l on umbilical cord or on an arterial or capillary blood sample obtained within 1 hour from birth OR moderate to severe encephalopathy
  5. Respiratory failure secondary to conditions other that RDS as identified by lung imaging (air leaks, lung malformations…)
  6. Any clinical condition which may place the infants at undue risk as deemed by clinicians
  7. Participation to trials with competitive outcomes or likely to have an impact on the primary outcome of the study
  8. Outborn patients

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Potroić

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: A/Control

Surfactant administration following clinical assessment
Inny: Surfactant administration following clinical assessment

Surfactant is administered following oxygenation-based criteria
Eksperymentalny: B/Intervention

Surfactant administration following both lung mechanics assessment and clinical assessment
Inny: Surfactant administration following lung mechanics assessment in addition to clinical assessment

Surfactant is administered following oxygenation-based criteria and if the Xrs is ≤ -23.3 cmH2O*s /L

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Days of respiratory support
Ramy czasowe: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"

Number of days of required respiratory support
From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
First surfactant administration
Ramy czasowe: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"

Time of first surfactant administration (in hours)
From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
Days of non-invasive respiratory support
Ramy czasowe: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"

Number of days of non-invasive respiratory support
From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
Days of invasive respiratory support
Ramy czasowe: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"

Number of days of invasive respiratory support
From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
Patients intubated and mechanically ventilated
Ramy czasowe: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"

Number of patients intubated and mechanically ventilated
From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
Patients receiving multiple surfactant doses
Ramy czasowe: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"

Number of patients receiving multiple surfactant doses
From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
Days on supplemental oxygen
Ramy czasowe: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"

Number of days on supplemental oxygen
From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
Total cumulative oxygen exposure
Ramy czasowe: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"

Total cumulative oxygen exposure computed as the time integral of the FiO2 values
From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
Infants receiving more than 28 days of respiratory support
Ramy czasowe: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"

Number of infants receiving more than 28 days of respiratory support
From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
Infants developing BPD
Ramy czasowe: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"

Number of infants developing BPD according to the definition by NICHD 2016
From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
Infants developing air-leaks
Ramy czasowe: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"

Number of infants developing air-leaks
From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
Infants developing prematurity-associated complications
Ramy czasowe: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"

Number of infants developing prematurity-associated complications (severe intraventricular haemorrhage (IVH), periventricular leukomalacia (PVL), necrotizing enterocolitis (NEC), sepsis, retinopathy of prematurity (ROP), patent ductus arteriosus requiring pharmacological or surgical treatment)
From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
Infants discharged home with oxygen or respiratory support
Ramy czasowe: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"

Number of infants discharged home with oxygen or respiratory support
From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
Days to achieve full-enteral feeding
Ramy czasowe: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"

Number of days to achieve full-enteral feeding (160 ml/kg/day of milk intake)
From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
Days of hospitalization
Ramy czasowe: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"

Number of days of hospitalization
From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
Infants receiving postnatal steroids
Ramy czasowe: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"

Number of infants receiving postnatal steroids
From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Współpracownicy

Politecnico di Milano

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

15 grudnia 2023

Zakończenie podstawowe (Szacowany)

30 maja 2028

Ukończenie studiów (Szacowany)

31 grudnia 2028

Daty rejestracji na studia

Pierwszy przesłany

9 grudnia 2022

Pierwszy przesłany, który spełnia kryteria kontroli jakości

28 marca 2023

Pierwszy wysłany (Rzeczywisty)

30 marca 2023

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

5 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

2 listopada 2026

Ostatnia weryfikacja

1 listopada 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • Sperimentazione 3115
  • Studio Numero 6379 (Inny identyfikator: Comitato Etico Milano Area 2)

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Subskrybuj