Oral Responses Associated with Colostrum Exposure in Neonates (ORACLE-Neo) - An Observational Study of NICU Oral Care Practices and Mucosal Immune Markers

Investigating Oral Care Practices in NICU Infants

Primary Investigator
K
Kok Lim Kua

Primary Investigator

Enrolling By Invitation
32 weeks or below
All
Phase N/A
40 participants needed
1 Location

Brief description of study

The goal of this study is to evaluate current oral care practices in the NICU (completed with oral swab with either mother's breast milk or sterile water) and correlate with infant outcomes primarily related to immune responses with secondary investigation into neonatal rates of infection, growth parameters and length of stay in the NICU.

THIS STUDY IS ENROLLING BY INVITATION ONLY - Eligible infants will be identified through daily screening of delivery logs, NICU admissions and obstetrician requests for NICU consult due to likely premature delivery. Parents or caregivers will be approached prior to delivery when feasible, or within 72 hours of birth. All research procedures will occur in the Riley Hospital for Children NICUs while infants are hospitalized.

Detailed description of study

The current clinical trial will evaluate the safety, tolerability and efficacy of Pirfenidone in patients with CP. Participants will be randomized 2:1 between Pirfenidone and placebo arm for 48 weeks.

Eligibility of study

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

  • Conditions: Premature birth or delivery, Riley
  • Age: 32 weeks or below
  • Gender: All

Inclusion Criteria:
Infants born at less than 32+0 weeks defined by first trimester ultrasound or last menstrual period who fall on feeding protocol
Infants weighing ≤1500 grams at birth who fall on feeding protocol
Parent/guardian present and able to provide consent for infant prior to birth or within the first 72 hours of life
English speaking parent/guardian

Exclusion Criteria:
Known lethal fetal anomaly
APGAR score of Cardiac anomaly
Renal anomaly
Gastrointestinal anomalies
Infant not delivered at Riley Hospital for Children

This study investigates the oral care practices in the Neonatal Intensive Care Unit (NICU) and their association with immune responses in infants. The purpose is to observe how different oral care methods, such as using a mother's breast milk or sterile water, relate to the health outcomes of infants, including their immune system response, infection rates, growth, and length of stay in the NICU.

Participants in this study will undergo oral swab procedures while hospitalized in the NICU. The study will collect data on immune markers and evaluate the safety and effectiveness of these oral care practices. An observational study is a type of research study where data is collected by observing participants receiving routine care, without changing their treatment, which may focus on people using specific medications or having certain conditions to better understand how treatments work.

  • Who can participate: Infants born before 32 weeks and weighing 1500 grams or less can participate if they are on a feeding protocol. A parent or guardian must be present to give consent within 72 hours of birth, and they must speak English.
  • Study details: Participants will have oral swabs taken while they are in the NICU to study immune markers. This is part of an observational study, meaning no changes are made to their treatment.
Updated on 14 Aug 2026. Study ID: 30677
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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