NCT07082881

Impact of Colostrum Oropharyngeal Immunotherapy on Postnatal Growth in Preterm Infants

Impact of Colostrum Oropharyngeal Immunotherapy on Postnatal Growth in Preterm Infants Based on Early Gut Microbiota-Host Interaction Patterns: A Protocol for a Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Suqian First Hospital · Academic / Other
• Sex: All
• Age: 0 Days – 1 Day
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to ascertain whether oropharyngeal administration of colostrum contributes to postnatal growth in very preterm infants (those born before 32 weeks of gestation). The main questions it aims to answer are: Can Oropharyngeal administration of colostrum effectively lower the incidence rate of extrauterine growth restriction (EUGR) in participants? Does oropharyngeal colostrum intervention bring about changes in the early gut microbiota of participants? Researchers will conduct a comparative analysis between colostrum and a placebo (normal saline) to investigate whether oropharyngeal administration of colostrum has a beneficial effect on the postnatal growth of participants. Participants will: Initiation of oropharyngeal colostrum administration will take place within 48 - 72 hours after birth, and the treatment will be administered continuously for a period of 5 days. Stool samples will be collected from the participants both before and after the intervention. Participants will be required to maintain a diary to document their basic characteristics and clinical outcomes.

Conditions

• Growth Failure
• Preterm Birth
• Microbiota

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-09-01
• Primary completion: 2028-08-31
• Completion: 2028-09-30
• First posted: 2025-07-24
• Last updated: 2025-07-24