Decades of studies have demonstrated the strong relationship between severe viral respiratory illnesses in the first years of life and the development of wheezing and asthma in childhood, particularly respiratory illnesses in the first years of life caused by respiratory syncytial virus (RSV) and human rhinovirus (HRV), which cause colds symptoms in children. However, most people affected by respiratory viruses are resistant to severe illness, recurrent wheezing, and asthma.

The aim of this study is to answer the question: Why do some children with respiratory viral infections develop severe respiratory illness, childhood wheezing, and asthma, while others do not? We believe there is a complex relationship between genetics, viral species, and environmental exposures in determining asthma risk.

1.Recruit and secure 3000 newborns to study the effects of early life viral respiratory illnesses on airway gene expression and asthma risk. We will follow the babies of Puerto Rican mothers during their first 5 years of life by collecting questionnaires and clinical data, as well as neonatal umbilical cord blood and blood material, and neonatal/infant nasal cell smears at birth, during respiratory illnesses, and in clinical examinations. annual.

2.To identify the viral and genetic determinants of severe respiratory diseases in the first years of life and whether differences in nasal airway cells at birth increase the chance of having these severe respiratory diseases. We will test whether severe respiratory illnesses are related to viral infection in general and/or infection with a specific viral species. We will use genetic data to identify genes that increase the risk of severe respiratory disease in the first years of life and genetic risks that influence how genes are expressed in the airways at birth and during disease.

3.To determine the relationship between the severity of respiratory diseases in the first years of life and the changes in the cells of the nasal airways that can increase the risk of wheezing and asthma. We will determine how genes expressed in the nasal airways change during early childhood naturally and in response to severe viral illness, and how these gene expression profiles relate to the risk of developing recurrent wheezing and asthma.

We will share our results through presentations and publications. No identifying information about the participants in this study will be shared in any presentation or publication.

As recruitment has just started, we are still in the early stages of research. Be sure to check our NEWS page for related media and announcements PRIMERO.

Please reach out through our CONTACT US page or contact us directly via email at jr@pedsthma.com or call (787) 309-5833 or (787) 743-1917

Babies will be followed from birth until the conclusion of the longitudinal observation period. Participation in the study will last for a maximum of five years.

Although PRIMERO is funded for only the first five years (through 2023), we hope that other researchers can use this cohort to study respiratory diseases for many decades to come.

Babies will be followed from birth until the conclusion of the longitudinal observation period. Participation in the study will last for a maximum of five years.

Enrollment: We will contact you at your OB/GYN provider's office with an information packet that includes a copy of our consent for you to review. We will assign you a PRIMERO ID and contact you by phone within a week to answer any questions you may have and start the consent process if you are interested. This may require an in-person visit. The next time you see us will be when you come to HIMA for labor and delivery. At the time of birth, the PRIMERO staff will collect a sample of your baby's umbilical cord blood. The day after you deliver, a PRIMERO nurse will come to you to reaffirm your consent, administer a questionnaire and draw a tube of blood, and a PRIMERO physician will draw a nasal swab from your baby.

Sick Visits: We will contact you every Tuesday by email or SMS text message to monitor your child for a respiratory illness. If you confirm that your child has one or more of the following symptoms, we will schedule your child for an in-person visit with a pediatric respiratory physician.

• runny/stuffy nose

• sneezing

• a slight cough

• a cough that interferes with daily activities

• presence of wheezing/wheezing

• rapid breathing or shortness of breath

• sleep disturbed by coughing

After your child is seen by a pediatric respiratory physician for their illness, PRIMERO staff will escort you and your child to an investigative exam room where we will administer a questionnaire, measure your child's vital signs, and collect a swab. nasal. At the end of this visit, you will be reimbursed for your parking costs, approximately $5.

Annual Visits: One month before your child's birthday, we will contact you to schedule your annual investigative visit. When you arrive at the CNP, PRIMERO staff will greet you and administer a questionnaire. We will collect a nasal swab and blood sample from your baby after the completion of the questionnaire. In addition, we will perform respiratory tests in year 3 and 4 to measure lung function. You will be given a thank you gift of approximately $30 at the end of each annual follow-up visit.

Study-related visits will include an enrollment visit, a birth visit, annual research visits, and respiratory disease surveillance visits. Recruitment visits will take place at the CNP (prenatal informed consent and eligibility), as well as at the Hospital Interamericano de Medicina Avanzada-San Pablo (HIMA) (consent reaffirmation and sample collection, before the mother and child are discharged from the maternity ward) and the rest. Visits will be conducted at CNP.

Your privacy is our #1 priority. This study will be monitored by an Observational Studies Monitoring Board. UCSF will serve as the data coordination center. Samples without identifying information about you or your child will be shipped to and stored at the University of California, San Francisco (UCSF) and National Jewish Health (NJH). Strict data storage and privacy procedures have been put in place in accordance with HIPAA guidelines to ensure your data is protected. For additional details.

El Centro de Neumología Pediátrica (CNP) is located within Hospital Interamericano de Medicina Avanzada-San Pablo (HIMA) in Caguas, Puerto Rico. CNP will carry out and manage the recruitment and follow-up. Recruitment will occur within HIMA's OB/GYN clinics and follow-up will take place at HIMA's labor and delivery unit and CNP.

➤ ADDRESS

El Centro de Neumología Pediátrica
HIMA Plaza I Suite 300
Caguas, Puerto Rico

Monday - Friday 8AM - 4PM

☎ CONTACT

jr@pedasthma.com
(787) 743-1917

Yes. After each sick visit, you will receive a thank-you gift to cover parking, approximately $5. After each annual research visit, you will receive a thank-you gift of approximately $30.

The surveys will be completed with the assistance of PRIMERO staff at Centro de Neumología Pediátrica (CNP), located within Hospital Interamericano de Medicina Avanzada-San Pablo (HIMA) in Caguas, Puerto Rico. Surveys will be completed in person or by phone at enrollment and at birth in the hospital, during your child's sick visit, and by phone for your child's annual visit. At the time of survey administration, a highly trained staff from PRIMERO will guide you through the questionnaire and answer any questions you may have.

If you have questions about your patient, please contact us through our CONTACT US page.