Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Enteral Lipid Supplementation and Bronchoplumonary Dysplasia of Premature Infants (PRELUDE)

11. juni 2026 opdateret af: Aristotle University Of Thessaloniki

Enteral Lipid Supplementation and Bronchoplumonary Dysplasia of Premature Infants: A Randomized Controlled Trial (The PRELUDE Trial)

The Impact of Omega-3 (DHA - Docosahexaenoic Acid) and Omega-6 (ARA - Arachidonic Acid) Supplementation on the Development of Bronchopulmonary Dysplasia in Extremely and Very Preterm Infants (24-29 weeks of gestational age).

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The intervention group will receive enteral supplementation with ARA and DHA (in a 2:1 ratio) in addition to standard care and feeding, while the control group will receive standard care and feeding. The intervention will commence within the first three days of life and will continue until 36 weeks postmenstrual age for both groups.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

74

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

Infants born at Papageorgiou Hospital in Neonatology Department and NICU of Aristotle University of Thessaloniki with GA equal to or less than 29 weeks are eligible to participate in the study.

Exclusion Criteria:

Congenital malformations, chromosomal abnormalities or critical illness with short life expectancy.

Study participation requires written informed parental consent within 48h after birth.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Enteral supplementation
Enteral supplementation with ARA and DHA (in a 2:1 ratio) in addition to standard care and feeding.
Kosttilskud: Enteral supplementation with ARA and DHA (in a 2:1 ratio) in addition to standard care and feeding
The intervention group will receive enteral supplementation containing arachidonic acid (ARA) and docosahexaenoic acid (DHA) in a 2:1 ratio, in addition to standard care and feeding. Supplementation will begin within the first three days of life and will continue until 36 weeks postmenstrual age.
Aktiv komparator: Routine practice
Routine clinical care and nutritional support
Andet: Standard care and feeding
The control group will receive routine clinical care and nutritional support according to current neonatal unit protocols, without additional ARA/DHA supplementation.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The presence or absence of bronchopulmonary dysplasia (BPD), as assessed by the need for respiratory support or supplemental oxygen at 36 weeks postmenstrual age.
Tidsramme: Up to 36th week of postmenstrual age
The occurrence of BPD will be determined based on the requirement for respiratory support or supplemental oxygen at 36 weeks postmenstrual age.
Up to 36th week of postmenstrual age

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Classification of BPD
Tidsramme: Up to 36th week of postmenstrual age
Classification of Jensen et al. (2019) proposed a revised definition of BPD based on a modification of the NICHD (2001) criteria, which classifies the severity of bronchopulmonary dysplasia at 36 weeks postmenstrual age according to the level of positive pressure respiratory support, rather than the use of supplemental oxygen. This classification is independent of the prior duration or current concentration of oxygen therapy and is defined as follows: no BPD (no respiratory support), Grade 1 (nasal cannula ≤2 L/min), Grade 2 (nasal cannula >2 L/min or non-invasive ventilation), and Grade 3 (invasive mechanical ventilation).
Up to 36th week of postmenstrual age
The presence of comorbidities such as retinopathy of prematurity, necrotizing enterocolitis, intraventricular haemorrhage, periventricular leukomalacia, patent ductus arteriosus, and late-onset sepsis
Tidsramme: Up to 40th week of postmenstrual age
Up to 40th week of postmenstrual age
Need of respiratory support
Tidsramme: Up to 40th week of postmenstrual age
The number of days requiring respiratory support (mechanical ventilation, continuous positive airway pressure (CPAP), high flow nasal cannula 3L/min or oxygen therapy).
Up to 40th week of postmenstrual age
Mean oxygen demand (FiO2) during respiratory support
Tidsramme: Up to 40th week of postmenstrual age
Up to 40th week of postmenstrual age
Mean tidal volume (ml/kg) during respiratory support
Tidsramme: Up to 36th week of postmenstrual age
Up to 36th week of postmenstrual age
Mean respiratory rate (RR/min) during respiratory support
Tidsramme: Up to 36th week of postmenstrual age
Up to 36th week of postmenstrual age
Use of postnatal steroids (yes/no)
Tidsramme: Up to 40th week of postmenstrual age
Up to 40th week of postmenstrual age
Change in weight z-score from birth to 36 weeks of postmenstrual age
Tidsramme: Up to 36th week of postmenstrual age
Up to 36th week of postmenstrual age

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Aristotle University Of Thessaloniki

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

4. marts 2025

Primær færdiggørelse (Anslået)

30. november 2026

Studieafslutning (Anslået)

1. marts 2027

Datoer for studieregistrering

Først indsendt

30. maj 2026

Først indsendt, der opfyldte QC-kriterier

11. juni 2026

Først opslået (Faktiske)

17. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 393/16-01-2025

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Deidentified Individual Participant Data (IPD) that underline published results, along with related data dictionaries, will be available from 3 months to 36 months following results' publication, only to researchers who will provide a methodologically sound proposal, for types of analyses to achieve aims in the approved proposal or for individual participant data meta-analysis, and only after acceptance of the proposed protocol by our Institution's IRB.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Bronkopulmonal dysplasi (BPD)

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Serbia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner