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Not yet recruiting NCT07082881

Impact of Colostrum Oropharyngeal Immunotherapy on Postnatal Growth in Preterm Infants

No phase Interventional Growth Failure Preterm Birth Microbiota

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Colostrum, Normal Saline.
Who it may be relevant to
Registry conditions: Growth Failure, Preterm Birth, Microbiota. Basic parameters: 0 Days — 1 Day · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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
  • 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.

Primary outcome measures

  • 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.]
Secondary outcome measures (3)
  • The inter-group variances in the gut microbiota of participants subsequent to the intervention [Time frame: The seventh day after birth]
  • Intergroup difference in the time to regain birth weight [Time frame: Up to 10 days, with an average of 5 days.]
  • The incidence rate of bronchopulmonary dysplasia [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.]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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

Identifiers

NCT: NCT07082881 · suqianFH

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗