Using pasteurized donor human milk for infants exposed to HIV
Pasteurized Donor Human Milk for HIV-Exposed Infants: A Pilot Study
This study tests if giving pasteurized donor human milk to infants exposed to HIV is a good alternative to formula feeding for their health and nutrition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | University of Saskatchewan Academic / other |
| Locations | 1 site (Saskatoon, Saskatchewan) |
| Trial ID | NCT06955715 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the feasibility of providing pasteurized donor human milk (PDHM) to infants exposed to HIV, as an alternative to formula feeding. Participants will include women living with HIV who have recently given birth or caregivers of HIV-exposed infants, residing in Saskatoon, Canada. Over a period of 6-8 weeks, PDHM will be delivered to participants' homes, and caregivers will track feeding habits and any challenges encountered. The study seeks to assess the nutritional and immunological benefits of PDHM for this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 15 and older living with HIV who have recently given birth or are primary caregivers of HIV-exposed infants.
Not a fit: Patients who are not living with HIV or whose infants are not exposed to HIV may not receive any benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve health outcomes for HIV-exposed infants by providing them with the immunological benefits of human milk.
How similar studies have performed: While the use of PDHM in neonatal intensive care units has shown success, its application for HIV-exposed infants is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria * ≥15 years of age * Pregnant or recently gave birth and living with HIV or is the primary caregivers of an HIV-exposed infant * Being followed by SHA Pediatric Infectious Disease * Saskatchewan resident (living within \~150 km from the University of Saskatchewan) * Have a household freezer * Willing to participate
Where this trial is running
Saskatoon, Saskatchewan
- University of Saskatchewan — Saskatoon, Saskatchewan, Canada (Recruiting)
Study contacts
- Principal investigator: Kelsey M Cochrane, PhD — University of Saskatchewan
- Study coordinator: Kelsey M Cochrane, PhD
- Email: kelsey.cochrane@usask.ca
- Phone: (306) 966-1310
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.