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

The UK 22 Week Study

27. maj 2026 opdateret af: Imperial College London

Clinical Management and Short-Term Outcomes of Neonates Born at 22 Weeks in the UK (The 22 Week Study)

In the UK, babies born at 22 weeks of pregnancy have only been offered survival-focused care (sometimes called resuscitation or stabilisation) since 2019. Very few babies are born this early each year and sadly a lot of them do not survive. Therefore, healthcare teams don't have much information about this new population of tiny babies and there is much to learn about how they respond, the problems they face and the best way for intensive care units to look after them.

This study aims to collect information available in babies' medical notes, analyse it and share learning to start improving this knowledge. There will be no changes to the babies' care, only observation of what happens.

A small team of doctors and nurse practitioners who have/are looking after a baby, will put a small amount of selected information, without 'identifiers' such as the baby's name, date of birth or hospital number, onto a secure database platform at Imperial College London (a university).

Researchers will analyse the information from all the babies around the UK together to look for trends and to describe common things that happen to them, as well as their outcomes.

Parents will be made aware this information is being collected and used through a leaflet. It will not be possible to identify an individual baby in the results.

The investigators are aiming for around 45 hospitals across the UK to participate. Babies born at 22 weeks gestation, who are attended to at birth by a neonatal team (or admitted) at an intensive care site over a 12-month period will be included. While collecting this information will not impact the babies included, it may help the treatment of babies born early in the future and give families more accurate information about what they might expect to happen.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Parents of eligible babies receive an information leaflet on how the pseudonymised data is used. A data collection team of trained clinical staff input the data (available in the notes) into a REDCap database.

Aims and Objectives

1. To describe and analyse the risk factors and clinical care for babies born at 22 weeks in UK neonatal intensive care units (NICUs)

Description:

  1. To determine whether management of infants born at 22 weeks align with British Association of Perinatal Medicine (BAPM) recommendations based on risk stratification
  2. To report the proportion of infants receiving interventions in the following areas of clinical care at a baby and network level: a. Delivery room stabilisation b. Respiratory & cardiovascular c. Neurological d. Gastroenterological & Surgical e. Renal f. Haematology g. Infection h. Skin, thermal management, monitoring 3.To report the short-term outcomes (survival or death) following neonatal care. Additional standard neonatal outcomes to be reported.

4. Where babies die, to report the timing, cause of death, whether reorientation to comfort care took place and influencing factors or indications for redirection.

Time Frame: From admission until death or discharge from neonatal care

2. To describe unit approaches and equipment for 22 week babies across the UK

Description: To conduct a national survey across the NICUs and report i) the proportion of units and networks which have protocols for the care of babies born at 22 weeks. ii) Report similarities and differences in clinical care approaches. iii) Report common challenges faced by teams caring for babies born at 22 weeks

Time Frame: One-off unit questionnaire on entering the study

3. Explore wider hypotheses and feasibility of longer term monitoring of this cohort

Description: To explore associations between baby and clinical care factors and outcomes. To generate hypotheses, inform the design of future studies, support proof of concept and feasibility for a larger scale study or registry for 22-week babies in the UK

Time Frame: Duration of study and analysis

Undersøgelsestype

Observationel

Tilmelding (Anslået)

100

Kontakter og lokationer

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

Studiekontakt

Undersøgelse Kontakt Backup

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
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

In United Kingdom

Beskrivelse

Inclusion Criteria:

  • Born at 22+0-22+6 weeks gestational age
  • Born in a NICU centre with neonatal team in attendance
  • Or admitted to a NICU within first 72 hours of life if outborn

Exclusion Criteria:

  • Less than or more than 22 weeks gestation at birth
  • Known congenital anomaly

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Babies born at 22 weeks in neonatal intensive care units in the UK
Attended to by neonatal team at birth or transferred into a NICU
Andet: Ikke relevant (observationsundersøgelse)
Ikke relevant (observationsundersøgelse)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Survival to discharge from neonatal care
Tidsramme: Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age
Survival to discharge from neonatal care
Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Core Neonatal Outcomes - BPD
Tidsramme: Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age
Bronchopulmonary Dysplasia at 36 weeks (Oxygen requirement)
Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age
Core Neonatal Outcomes - ROP
Tidsramme: Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age
Retinopathy Of Prematurity requiring Treatment
Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age
Core Neonatal Outcomes - Severe brain injury
Tidsramme: Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age
Intraventricular haemorrhage grades 3-4, Periventricular Leucomalacia
Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age
Core Neonatal Outcomes - NEC
Tidsramme: Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age
Necrotising Enterocolitis or Perforation (any cause) requiring surgical intervention
Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age
Core Neonatal Outcomes - LOS
Tidsramme: Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age
Late-onset sepsis (culture positive) >72 hours of age
Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age

Samarbejdspartnere og efterforskere

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

Sponsor

Imperial College London

Samarbejdspartnere

Chelsea and Westminster NHS Foundation Trust
CW+ Charity
NeoTRIPs - British Association of Perinatal Medicine associated group of neonatal trainee-led research, education and QI network
Kids Intensive Care and Decision Support & Neonatal Transfer Service (KIDSNTS), Birmingham Women's and Children's NHS Foundation Trust

Efterforskere

  • Studieleder: Cheryl WS Battersby, Imperial College London

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

Hjælpsomme links

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)

1. juni 2025

Primær færdiggørelse (Anslået)

1. juni 2027

Studieafslutning (Anslået)

1. december 2027

Datoer for studieregistrering

Først indsendt

23. marts 2026

Først indsendt, der opfyldte QC-kriterier

27. maj 2026

Først opslået (Faktiske)

1. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IRAS 346626

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

IPD will not be shared due to small numbers to prevent any potential identification and due to ethical approval limits

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 Spædbarn, ekstremt for tidligt

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Trinidad & Tobago

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner