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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Cheryl WS Battersby
- Numero di telefono: 02075941862
- Email: c.battersby@imperial.ac.uk
Backup dei contatti dello studio
- Nome: Helen McDermott
- Email: h.mcdermott@imperial.ac.uk
Luoghi di studio
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London, Regno Unito
- Reclutamento
- Imperial College
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Contatto:
- Helen McDermott
- Email: h.mcdermott@imperial.ac.uk
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Contatto:
- Cheryl WS Battersby
- Email: c.battersby@imperial.ac.uk
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
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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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Non applicabile (studio osservazionale)
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Survival to discharge from neonatal care
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Core Neonatal Outcomes - BPD
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Direttore dello studio: Cheryl WS Battersby, Imperial College London
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- IRAS 346626
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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