Pasteurized Donor Human Milk for HIV-Exposed Infants: A Pilot Study
A legfontosabb adatok
- Hol
- Saskatoon (Kanada)A helyszín megnézése
AI-kivonat: kiket keres a vizsgálat
A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.
A vizsgálat olyan embereket keres, akik terhesek vagy nemrég szültek és HIV-vel élnek, vagy egy HIV-nek kitett csecsemő fő gondozói. A vizsgálat adományozott anyatejet vizsgál a baba számára.
- Életkor
- 15 éves vagy idősebb
- Nem
- Bármely nem részt vehet
A részvétel fő kizáró okai
- Nem az SHA gyermekfertőzőbetegség-szakrendelésen követik
- Nem saskatchewani lakos (a University of Saskatchewantól körülbelül 150 km-en (93 mérföld) belül él)
- Nincs otthoni fagyasztója
- Nem hajlandó részt venni
Gépi kiolvasás: 2026. november 12.
Helyszínek itt: Kanada
- University of SaskatchewanSaskatoon, KanadaContact: Chloe Langen, MSc (Candidate)Résztvevőt keres
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- University of Saskatchewan
- Azonosító
- NCT06955715
- A regiszteradat frissítve
- 2025. november 19.
- Eredeti leírás
Pasteurized Donor Human Milk (PDHM) is recognized as providing vital immunological and nutritional benefits to vulnerable infants. Although PDHM is widely used in neonatal intensive care units (NICUs) to prevent infections (necrotizing enterocolitis) and improve infant health outcomes, its use for other populations, such as HIV-exposed infants, has been minimal.A teljes eredeti leírásKevesebb
Pasteurized Donor Human Milk (PDHM) is recognized as providing vital immunological and nutritional benefits to vulnerable infants. Although PDHM is widely used in neonatal intensive care units (NICUs) to prevent infections (necrotizing enterocolitis) and improve infant health outcomes, its use for other populations, such as HIV-exposed infants, has been minimal.
Pasteurized donor human milk is included in the 2023 Canadian Paediatric Society clinical consensus as a potential way to provide HIV-exposed infants some of the immunological benefits of human milk in a safe manner, as opposed to exclusive formula feeding (which is currently considered the gold standard for HIV-exposed infants). These new consensus guidelines also include recommendations to support those who wish to breastfeed using a harm reduction approach (e.g., increased viral load monitoring by peds infectious diseases), given the low risk of transmission in those adhering to antiretroviral medications. However, mixed feeding (e.g., breastfeeding and provision of infant formula) is not recommended, due to the potential for micro abrasions in the gastrointestinal epithelium as a result of the protein size in infant formula (which is larger and more abrasive than in human milk), which may increase the risk of HIV transmission if the HIV virus is present in breastmilk. As such, donor milk also presents a possible solution to support those who choose to breastfeed, but who may require a temporary supplement for whatever reason (e.g., nipple cracks, mastitis, etc.), as donor milk is human milk, thus has the same size of proteins and does not pose the same risk as infant formula in damaging the epithelial layer in the gut.
Overall, major obstacles remain that prevent newborns outside of the NICU from regularly having access to donor human milk. These obstacles are illustrated by the high cost of donor milk, which is not covered by government programs, and the lack of information about the clinical benefits (for both those who choose to breastfeed or formula feed), acceptability of caregivers for this feeding option, and feasibility of providing donor human milk outside of a hospital setting.
The investigators aim to determine whether giving PDHM to infants exposed to HIV is a practical possibility and learn from caregivers about any challenges associated with this feeding option. The results of this study will guide future research and a potential provincial initiative to expand access to PDHM for this population.
Bevonási feltételek: ≥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.