Impact of Colostrum Oropharyngeal Immunotherapy on Postnatal Growth in Preterm Infants (IOCOIOPGIPI)

Suqian First Hospital

Status: Not yet enrolling

Conditions: Growth Failure; Microbiota; Preterm Birth

Treatments: Other: Colostrum; Other: Normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT07082881

suqianFH

Details and patient eligibility

About

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.

Enrollment: 220 estimated patients

Sex: All

Ages: Under 1 day old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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220 participants in 2 patient groups, including a placebo group

Colostrum Oropharyngeal Immunotherapy

Experimental group

Description:

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.

Treatment:

Other: Colostrum

oropharyngeal normal saline administration

Placebo Comparator group

Description:

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.

Treatment:

Other: Normal Saline