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Impact of Colostrum Oropharyngeal Immunotherapy on Postnatal Growth in Preterm Infants

NCT07082881 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2025-07-24

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Suqian First Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
0 Days
Max Age
1 Day
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2028-08-31
Completion
2028-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07082881 on ClinicalTrials.gov