Impact of Colostrum Oropharyngeal Immunotherapy on Postnatal Growth in Preterm Infants

NANot yet recruitingINTERVENTIONAL
Enrollment

220

Participants

Timeline

Start Date

September 1, 2025

Primary Completion Date

August 31, 2028

Study Completion Date

September 30, 2028

Conditions
Growth FailurePreterm BirthMicrobiota
Interventions
OTHER

Colostrum

The treatment group will undergo the following treatment protocol within the initial 48-72 h: Investigators will select storage bags with the closest lactation time to the current time while wearing sterile gloves for the entire procedure. Next, using two 1-mL sterile syringes, investigators will draw 0.1 mL of colostrum from each bag and tightly cap the needle hubs to ensure hygiene and safety. Each syringe will be labeled with the hospitalization number, the infant's name, and the date of the mother's colostrum expression. The bags will be then left to sit at room temperature for 5 min to reach an appropriate temperature for oropharyngeal administration of the colostrum. Subsequently, the tip and cap of the first syringe will be removed, and the colostrum will be slowly injected along the right oral mucosa of the participants, lasting at least 20 s. After injection, a sterile cotton swab will be used to gently wipe the right buccal mucosa for at least 10 s.

OTHER

Normal Saline

For the control group, normal saline will be used instead of colostrum. The rest of the procedure will be the same as that for the treatment group.

All Listed Sponsors
lead

Suqian First Hospital

OTHER

NCT07082881 - Impact of Colostrum Oropharyngeal Immunotherapy on Postnatal Growth in Preterm Infants | Biotech Hunter | Biotech Hunter