Cohort study of fever neonates with confirmed community infection of SARS-CoV-2 Omicron: A study Protocol

Introduction Reports on neonatal coronavirus disease (COVID) have been focused on vertical transmission. There was little information on prevalence of neonates with COVID till up to 18 months of age. It is well known that breastfeeding is beneficial for the growth and development of infants. We hypothesized that breastfeeding will be beneficial for a better prevalence of neonatal COVID. The objective of this study is to explore the prognosis of fever neonates with confirmed community infection of SARS-CoV-2 Omicron, and to clarify whether human milk breastfeeding is beneficial for reducing the rate of severe SARS-CoV-2 Omicron infection in neonates. Methods and analysis This is a prospective single centre cohort study. Study period is from December, 2022 to December 2024. Inclusion criteria are: (1) Age ≤ 28 days or corrected age ≤ 44 weeks. (2) Fever. (3) Both tests (throat swab) of nucleic acid and antigen of SARS-CoV-2 Omicron were positive. (4) Parents signed the consents. Exclusion criteria is confirmed brain malformations. Patients will be classified into breastfeeding, mixed feeding, and formula feeding groups. The estimate sample size will be 200. The throat swab of infants will be collected for SARS-CoV-2 omicron nucleic acid ad antigen examination. Neonatal COIVD patients will be treated in the Out-Patient Department or admitted to Neonatal Intensive Care Unit according to the severity of infection. All patients will be followed at 3/6/12/18M of age. The endpoint to study was at 18 months of age. Data will be collected by Case Record Form and Electronic Data Capture from the History of In-hospital System. The primary outcome was the rate of severe SARS-CoV-2 infection. SPSS 20.0 software will used for statistical analysis. Ethics and dissemination It is approved by local Institute of Ethics Review Board (#[2022]-E-240-Y). Registration It is registered in the Chinese Clinical Trail Registry () (ChiCTR2200067148) Strengths and limitations of this study 1. This is a prospective single centre cohort study for fever neonates with confirmed community infection of SARS-CoV-2 Omicron. 2. Patients are categorized into breastfeeding group, mixed feeding group, and formula group. 3. The primary outcome is rate of severe SARS-CoV-2 infection. 4. The secondary outcomes include in-hospital outcomes and follow-up outcomes at 3M/6M/12//18M. 5. Limitation are the observational nature and the single centre data. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Protocols ### Funding Statement This study is supported by National Key Research and Development Program of China (#2022YFC2704805) (issued to Dr. Mingyan Hei). ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: It is approved by local Institute of Ethics Review Board of beijign Children's Hospital (#[2022]-E-240-Y) I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors * CDC : Centers for Disease Control COVID : coronavirus disease DQ : development quotient IRB : Institutional Ethics Review Board NICU : neonatal intensive care unit OPD : out-patient department