Impact of Colostrum Oropharyngeal Immunotherapy on Postnatal Growth in Preterm Infants

Sponsor
Suqian First Hospital
Study ID
NCT07082881
Status
Not Yet Recruiting

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Conditions

  • Growth Failure
  • Microbiota
  • Preterm Birth

Eligibility Criteria

Sex
ALL
Age
0 Days - 1 Day
Healthy Volunteers
Not accepted

Interventions

  • Colostrum — OTHER
    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.
  • Normal Saline — OTHER
    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.

Study Details

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.

Key Dates

First listed
Jul 24, 2025
Start date
Sep 1, 2025
Status verified
Jul 2025
Primary completion
Aug 31, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
220 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Colostrum Oropharyngeal Immunotherapy
    The study population will be randomly assigned to either the oropharyngeal colostrum administration group or the normal saline administration group. The intervention will commence within 48-72 h of birth and will be administered continuously for a duration of 5 days, with stool samples collected from the preterm infants before and after the intervention.
  • Placebo Comparator: oropharyngeal normal saline administration
    The study population will be randomly assigned to either the oropharyngeal colostrum administration group or the normal saline administration group. The normal saline administration will commence within 48-72 h of birth and will be administered continuously for a duration of 5 days, with stool samples collected from the preterm infants before and after thenormal saline administration.

Primary Outcome Measure

The incidence rate of extrauterine growth restriction (EUGR) among participants at the time of hospital discharge [ Time Frame: The time frame extends from the first day of hospitalization to the day of discharge, covering the entire inpatient stay, with an average duration of 1.5 months. ]

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