Sample Collection for Research Studies Related to Pulmonary Disorders and Other Diseases of Interest in Infants (Infant Biobank)

Investigating Pulmonary Disorders in Infants

S
Stephanie Adaikalam

Primary Investigator

Enrolling By Invitation
1 years or below
All
Phase N/A
20 participants needed
1 Location

Brief description of study

The broad scientific objective of the Division of Pediatric Pulmonology, Allergy-Immunology and Sleep Medicine (PPUL) at Riley Hospital for Children is to promote translational research for the improved understanding and advancement in the treatment of health disorders. The ability to successfully investigate the biological basis of diseases, translate basic research to the clinical setting, and better understand clinical phenomena is greatly facilitated by the availability of an extensive repository of samples linked to clinical data. To achieve this specific goal within the neonatal population, this focused protocol establishes the Pediatric Pulmonary Biobank for the neonate population (PPUL Infant Biobank). 

A. To provide uniform central collection, standardized processing, quality control, and a state-of-the-art repository for samples collected from infants with lung disease. 

B. To provide samples to PPUL investigators and other approved collaborators to examine relevant cellular, genetic and molecular properties of diseases of interest.

THIS STUDY IS ENROLLING BY INVITATION ONLY - Potential participants may be identified during a clinical encounter and/or by reviewing RIley NICU patients. If patients are approached while in clinic, a member of the research team will discuss the study and proceed with informed consent/assent if the patients are willing.

Detailed description of study

The purpose of this study is to collect specific samples from infants with pulmonary-related disorders.

SAMPLE COLLECTION

A.    Tracheal Aspirates: Tracheal aspirates will be collected only when the infant already has an endotracheal tube in place and is undergoing routine clinical suctioning to clear the airway. Secretions that would normally be discarded may be collected for research purposes. A small amount of saline may be used in the suction catheter to help move secretions through the tube, but saline will not be instilled into the endotracheal tube unless it is part of clinical care. Samples will be transported to the laboratory, aliquoted as needed, and stored at -80oC.

B.    Bronchoalveolar Lavage (BAL) Fluid: BAL fluid will be collected only during clinically indicated bronchoscopy. The pulmonologist will obtain any fluid needed for diagnostic purposes first. Any remaining fluid will be transported to the laboratory and centrifuged to separate the cell pellet and supernatant. Protease inhibitor will be added to the cell pellet prior to freezing. Both fractions will be stored at -80oC. Downstream processing will depend on the specific IRB-approved research use.

C.    Airway Lining: Airway lining brushings will be obtained only during clinically indicated bronchoscopy, under direct visualization. A very small, soft brush will be used to gently collect airway lining cells and fluid from the trachea and bronchi from both sides. No infant will undergo bronchoscopy solely for the purpose of obtaining airway lining samples.

Samples will be transported immediately to the laboratory for processing. Cells may be placed into culture for expansion and stored until ready for further analysis. These samples may be used for transcriptomic analyses (e.g., single‑cell sequencing) or mechanistic experiments evaluating epithelial responses to environmental or pharmacologic stimuli. No genomic sequencing is planned.

D.    Chest MRI: Chest MRI is a research imaging procedure performed to evaluate the lungs and airway. Infants will undergo chest MRI only if the clinical team determines they are medically stable to travel to radiology without additional sedation beyond their baseline care. When possible, if the infant is already traveling to radiology for clinically indicated imaging (such as a head MRI), the research chest MRI may be performed during the same trip.

The chest MRI will take place without changes to the infant’s baseline respiratory support (e.g., room air, high‑flow nasal cannula, or mechanical ventilation via an endotracheal tube), except for the temporary PEEP adjustment described below. The MRI scan may include both clinical and research MRI protocols, including but not limited to ultra‑short echo time (UTE) sequences. No contrast agents or special inhaled gases will be used.

If the infant is receiving invasive mechanical ventilation, the positive end‑expiratory pressure (PEEP) will be reduced to 4 cmH₂O below the baseline setting, not to be reduced below 10 cmH₂O. PEEP will be returned to baseline immediately after the MRI is completed.

A repeat chest MRI may be obtained at a later time point to evaluate changes over time, provided the infant remains clinically stable to undergo MRI. Any repeat imaging will follow the same safety criteria described above.

MRI data will be stored on secure institutional servers and linked to the subject’s study ID.

Airway Lining Brush – A very small, soft brush will be used to collect airway lining samples from different areas of the trachea and bronchi from both sides.

Chest MRI – Magnetic Resonance Imaging will be performed to evaluate the chest, including lungs and airway.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Heart disease, Pulmonary disease, Riley
  • Age: 1 years or below
  • Gender: All

A.    Inclusion
1)    Infants under 1 year of age with pulmonary disease that begins in, or is managed during, the neonatal ICU period at Riley Hospital for Children. 
2)    A pediatric pulmonologist is involved in the infant’s care, either as the primary service or as a consulting service.

B.    Exclusion
1)    Any acute or chronic condition that the clinical team determines makes the procedure unsafe for the infant at the time of evaluation. If circumstances change, infants may be reevaluated for participation.

The purpose of this study is to collect specific samples from infants with pulmonary-related disorders. This study investigates pulmonary disorders in infants, focusing on conditions that begin or are managed during the neonatal ICU period. Pulmonary disorders affect the lungs and breathing. The study will gather samples to help researchers understand these conditions better.

In this study, samples like tracheal aspirates and bronchoalveolar lavage fluid will be collected. Tracheal aspirates are taken during routine suctioning, and bronchoalveolar lavage fluid is gathered during bronchoscopy. Airway lining samples will also be collected with a small brush during bronchoscopy. Additionally, chest MRI scans will be performed to evaluate the lungs and airway.

  • Who can participate: Infants under 1 year of age with pulmonary disease managed during the neonatal ICU period at Riley Hospital for Children can participate. A pediatric pulmonologist must be involved in their care.
  • Study details: Participants will have samples collected during routine medical procedures, such as suctioning and bronchoscopy. A chest MRI may be done if the infant is stable. No procedures will be introduced solely for research purposes.
Updated on 12 May 2026. Study ID: PPUL-IIR-INFANT-BIOBANK, 30174
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only