Impact of Colostrum Oropharyngeal Immunotherapy on Postnatal Growth in Preterm Infants

NCT ID: NCT07082881

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2028-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Colostrum

Intervention Type: 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.

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.

Group Type: PLACEBO_COMPARATOR

Normal Saline

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Gestational age <32 weeks and birth weight <1500 g;

2. admitted to the NICU of one of the five hospitals mentioned above within 24 h of birth; and

3. able to initiate the protocol within 72 h of birth and continuously provide adequate colostrum until the end of the protocol.

Exclusion Criteria

1. Death within 48 h;

2. severe birth asphyxia (defined as umbilical artery/first-hour arterial blood gas pH < 7.0);

3. birth with severe gastrointestinal malformations (e.g., intestinal atresia, tracheoesophageal fistula, malrotation of the intestines, and Hirschsprung's disease);

4. prenatal diagnosis of congenital chromosomal abnormalities or suspected congenital genetic metabolic diseases; and

5. maternal substance abuse or contraindications to breastfeeding (e.g., HIV).

• Minimum Eligible Age: 0 Days
• Maximum Eligible Age: 1 Day
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suqian First Hospital

OTHER

Sponsor Role: lead

Responsible Party

Na Wang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Wang N, Hu Y, Qiu W, He M, Zang Q, Wang B, Tang B, Zhang H, Ni P, Zhu S, Zhang J. Impact of colostrum oropharyngeal immunotherapy on postnatal growth in preterm infants based on early gut microbiota-host interaction patterns: protocol for a randomized controlled trial. Int Breastfeed J. 2025 Sep 29;20(1):72. doi: 10.1186/s13006-025-00769-7.

Reference Type: DERIVED

PMID: 41024070 (View on PubMed)

Other Identifiers

suqianFH

Identifier Type: -

Identifier Source: org_study_id