Clinical trial NCT04386109: Neonatal Complications of Coronavirus Disease (COVID-19)
Official title: Neonatal Complications of Coronavirus Disease (COVID-19)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neonatal COVID-19 Disease
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Imperial College London
name: University of Leicester
name: University of Nottingham
name: University of Glasgow
name: University Hospital of Wales
name: Public Health England
name: St George's, University of London
First posted: 2020-05-13
Enrollment: 500
Sex: ALL
Minimum age (years): 1
Maximum age (years): 29
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Babies admitted for neonatal care in: a neonatal unit, a paediatric intensive care unit or an in-patient ward.

Brief summary: There is an evidence gap in relation to the incidence, impact and severity of COVID-19 in newborn babies. International data are very limited, we have no robust estimates of incidence and no UK-based data with which to inform policy, clinical care, service delivery or advice to pregnant women.

The research aims are to investigate the three mains ways in which COVID-19 might affect newborns and babies that need neonatal care:

1. Newborn babies might catch COVID-19 before, during or soon after birth and this may lead to problems with breathing or feeding that need support in hospital.
2. COVID-19 could affect babies that are already on neonatal units with other medical conditions (like being very premature) that place them at greater risk of severe COVID-19.
3. COVID-19 might affect that way that pregnant women are looked after in pregnancy, labour or bith which could lead to problems for some babies, even if they do not themselves become infected with COVID-19.

Detailed description: The investigators have established a national (UK-wide) active surveillance study using the standard British Paediatric Surveillance Unit (BPSU) approach.

Since the 1st April 2020 case notifications are being collected using the BPSU 'orange eCard' approach. Eligible babies are: neonatal COVID-19 in babies (\<29 days old) in neonatal units, paediatric intensive care units and other in-patient locations and where neonates are born to COVID-19 mothers and require neonatal care. Notification cards are being sent weekly rather than the usual monthly pattern, this is so we are able to monitor case returns in 'real-time'. When paediatricians notify a case they are sent a data collection sheet which is returned complete to the BPSU-COVID-19 team at the NPEU.

The primary data collected in the study will also be cross-linking with data from: a parallel NIHR funded study of COVID-19 mothers being carried out using the UK Obstetric Surveillance System (UKOSS); MBRRACE-UK, the national surveillance of perinatal deaths; the Paediatric Intensive Care Audit Network (PICANet); and PHE England, PHS Scotland, PHS Wales and the HSC Public Health Agency Northern Ireland. This is to ensure complete case ascertainment. A later linkage will be carried out with the National Neonatal Research Database (NNRD) in order to collect more detailed clinical information.

As data are weekly reports of the findings will be generated to inform the development of policy and practice. The findings will be sent together with the UKOSS findings to: the decision makers responsible for the COVID-19 control policy at NHSE, DHSC, the Scottish, Welsh and NI governments, as well as the Royal Colleges of Paediatrics and Child Health and Obstetricians and Gynaecologists (RCPCH \& RCOG respectively), and the British Association of Perinatal Medicine (BAPM). This will ensure that policy, advice to pregnant women and parents and guidance for practice benefits from the most up to date information.

Follow-up at 3 months post-notification will be carried out in order to collect the final outcomes for each baby as the first data collection will be completed when a substantial proportion of babies will still be in-patients.

Data will also be shared (subject to appropriate approvals and data sharing agreements) with the COVID-19 registries that are being developed in the UK and across Europe.

Eligibility criteria: Inclusion Criteria:

* Any baby:

  1. That has a diagnosis of COVID-19 made on a sample taken before 29 days of age and receives inpatient care for COVID-19 (this includes postnatal ward, neonatal unit, paediatric inpatient wards, PICU) OR
  2. Where the mother had confirmed COVID-19 at the time of birth or suspected COVID-19 at the time of birth that has subsequently been confirmed, and the baby was admitted for neonatal care

     Exclusion Criteria:

Primary outcomes:
measure: Incidence of neonatal COVID-19
timeFrame: April 2020 to March 2021
measure: Incidence of vertically transmitted COVID-19
timeFrame: April 2020 to March 2021
Secondary outcomes:
measure: Presentation and natural history of neonatal COVID-19
timeFrame: April 2020 to March 2021
measure: Presentation of neonates with COVID-19 positive mothers
timeFrame: April 2020 to March 2021
measure: Outcomes for neonates with COVID-19
timeFrame: April 2020 to March 2021
measure: Clinical treatment of neonatal COVID-19
timeFrame: April 2020 to March 2021
measure: Neonatal secondary impacts of maternal COVID-19
timeFrame: April 2020 to March 2021
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College
Study officials:
affiliation: University of Oxford
name: Professor J Kurinczuk, MBChB,MSc,MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Imperial College London
name: Dr C Gale, MBBS,MSc,PhD
role: PRINCIPAL_INVESTIGATOR
References: