Impact of Colostrum Oropharyngeal Immunotherapy on Postnatal Growth in Preterm Infants
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-1
SponsorSuqian First Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Colostrum
- Normal Saline
Treatment groups
220 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov