Impact of Colostrum Oropharyngeal Immunotherapy on Postnatal Growth in Preterm Infants

NCT07082881 | Not Yet Recruiting

• 1 other identifier: suqianFH
• Study Type: interventional
• Target: 220
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• The incidence rate of extrauterine growth restriction (EUGR) among participants at the time of hospital discharge

  EUGR is defined as the situation where the growth measurement (weight, head circumference, or body length) taken at the time of discharge is less than or equal to the 10th percentile of the predicted value based on the Fenton 2013 growth chart.

  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.

Secondary Outcomes (3)

• The inter-group variances in the gut microbiota of participants subsequent to the intervention

  The seventh day after birth

• Intergroup difference in the time to regain birth weight

  Up to 10 days, with an average of 5 days.

• The incidence rate of bronchopulmonary dysplasia

  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.

Study Arms (2)

Colostrum Oropharyngeal Immunotherapy

EXPERIMENTAL

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.

Other: Colostrum

oropharyngeal normal saline administration

PLACEBO COMPARATOR

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.

Other: Normal Saline

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.

Colostrum Oropharyngeal Immunotherapy

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.

oropharyngeal normal saline administration

Eligibility Criteria

• Age: 0 Days - 1 Day
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Gestational age \<32 weeks and birth weight \<1500 g;
• admitted to the NICU of one of the five hospitals mentioned above within 24 h of birth; and
• able to initiate the protocol within 72 h of birth and continuously provide adequate colostrum until the end of the protocol.

You may not qualify if:

• Death within 48 h;
• severe birth asphyxia (defined as umbilical artery/first-hour arterial blood gas pH \< 7.0);
• birth with severe gastrointestinal malformations (e.g., intestinal atresia, tracheoesophageal fistula, malrotation of the intestines, and Hirschsprung's disease);
• prenatal diagnosis of congenital chromosomal abnormalities or suspected congenital genetic metabolic diseases; and
• maternal substance abuse or contraindications to breastfeeding (e.g., HIV).

Sponsors & Collaborators

• Suqian First Hospital: lead

Related Publications (1)

• 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.

  PMID: 41024070 DERIVED

MeSH Terms

Conditions

Failure to Thrive; Premature Birth

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 5, 2025
• First Posted: July 24, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: July 24, 2025

Record last verified: 2025-07