The UK 22 Week Study
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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:
- To determine whether management of infants born at 22 weeks align with British Association of Perinatal Medicine (BAPM) recommendations based on risk stratification
- 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
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Cheryl WS Battersby
- Telefonnummer: 02075941862
- E-Mail: c.battersby@imperial.ac.uk
Studieren Sie die Kontaktsicherung
- Name: Helen McDermott
- E-Mail: h.mcdermott@imperial.ac.uk
Studienorte
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London, Vereinigtes Königreich
- Rekrutierung
- Imperial College
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Kontakt:
- Helen McDermott
- E-Mail: h.mcdermott@imperial.ac.uk
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Kontakt:
- Cheryl WS Battersby
- E-Mail: c.battersby@imperial.ac.uk
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
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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
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Nicht anwendbar (Beobachtungsstudie)
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Survival to discharge from neonatal care
Zeitfenster: Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age
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Survival to discharge from neonatal care
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Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Core Neonatal Outcomes - BPD
Zeitfenster: Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age
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Bronchopulmonary Dysplasia at 36 weeks (Oxygen requirement)
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Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age
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Core Neonatal Outcomes - ROP
Zeitfenster: Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age
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Retinopathy Of Prematurity requiring Treatment
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Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age
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Core Neonatal Outcomes - Severe brain injury
Zeitfenster: Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age
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Intraventricular haemorrhage grades 3-4, Periventricular Leucomalacia
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Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age
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Core Neonatal Outcomes - NEC
Zeitfenster: Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age
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Necrotising Enterocolitis or Perforation (any cause) requiring surgical intervention
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Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age
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Core Neonatal Outcomes - LOS
Zeitfenster: Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age
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Late-onset sepsis (culture positive) >72 hours of age
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Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age
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Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Studienleiter: Cheryl WS Battersby, Imperial College London
Publikationen und hilfreiche Links
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- IRAS 346626
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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