Detection of enterovirus infection in hospitalized neonates

Study on the diagnostic value of enterovirus nucleic acid test in throat swab of hospitalized neonates

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2100049009

Enrollment

Unknown

Registered

2021-07-19

Start date

2021-05-01

Completion date

Unknown

Last updated

2022-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enterovirus infection

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) the gestational age at birth >=28WK; (2) Age of admission 48 hours; (4) The guardian signed the informed consent.

Exclusion criteria

Exclusion criteria: (1) congenital structural malformations of the mouth or nasopharynx (congenital malformations refer to the existence at birth of a recognizable defect in the form of an organ or body; severe malformations refer to malformations that produce dysfunction and require non-surgical or surgical treatment); (2) Parents give up treatment within 48 hours after admission; (3) Birth weight <=400g; (4) patients receiving placebo therapy; (5) Medical disputes with medical staff; (6) Patients with obvious traumatic disease lesions in the mouth or nasopharynx; (7) Patients who had received local oral and nasal irrigation before admission.

Design outcomes

Primary

Measure	Time frame
incidence of positive enterovirus nucleic acid test;	—

Secondary

Measure	Time frame
diagnostic spectrum;symptoms and signs;total hospital stay;whole blood count;coagulation;incidence of positive enterovirus antibody test;recovering status at discharge;medical expenses;mortality rate;	—

Countries

China

Contacts

Public ContactMingyan Hei

Beijing Children's Hospital, Capital Medical University, National Center for Children's Health (Beijing)

heimingyan@bch.com.cn+86 13370179319

Outcome results