The Role of Gut Microbiota-Host Interactions in Immune Development of Preterm Infants: Exploring the Potential and Mechanisms of Maternal Milk Oral Care

The Role of Gut Microbiota-Host Interactions in Immune Development of Preterm Infants: Exploring the Potential and Mechanisms of Maternal Milk Oral Care - The Effect of Human Milk Oral Care on Intestinal Microbiota Colonization and Short-Term Outcomes in Preterm Infants: A Multi-Center, Double-Blind, Controlled Randomized Clinical Trial

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500101147

Enrollment

Unknown

Registered

2025-04-21

Start date

2025-08-12

Completion date

Unknown

Last updated

2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm infants ( 28 <GA <= 34weeks)

Interventions

Breast Milk Oral Care Group:Breast milk (0.4mL) was aspirated into a 1mL syringe, followed by 5-minute room temperature incubation

0.2mL aliquots were uniformly applied to bilateral oral mucosa surfaces using sterile technique, administered at 3-hour intervals (8 times daily) with each application lasting =2 minutes. The protocol

Saline Oral Care Group:Normal saline (0.4mL) was aspirated into a 1mL sterile syringe and incubated at room temperature for 5 minutes. Subsequently, 0.2mL aliquots were uniformly applied to bilateral

Eligibility

Sex/Gender

All

Age

No minimum to 1 Years

Inclusion criteria

Inclusion criteria: 1. Preterm infants with gestational age of 28 weeks < GA <= 34 weeks; 2. Admission to the neonatal intensive care unit (NICU) within 6 hours after birth; 3. Maternal human milk available within 48 hours after delivery; 4. Signed informed consent obtained from legal guardians; 5. Completion of the full nursing intervention protocol.

Exclusion criteria

Exclusion criteria: 1. Congenital gastrointestinal malformations (e.g., intestinal atresia, tracheoesophageal fistula, intestinal malrotation, Hirschsprung’s disease); 2. Confirmed congenital chromosomal abnormalities; 3. Inborn errors of metabolism; 4. Birth asphyxia (defined as umbilical artery blood or arterial blood pH <7.0 within the first postnatal hour, or requiring delivery room cardiopulmonary resuscitation); 5. Neonatal sepsis; 6. Postnatal surgical interventions; 7. Maternal substance abuse (narcotics, psychoactive substances, volatile organic solvents, tobacco, or alcohol); 8. Maternal contraindications to breastfeeding (HIV infection, cytomegalovirus infection); 9. Maternal broad-spectrum antibiotic use within 2 weeks antepartum, excluding prophylactic administration (e.g., cesarean section); mothers providing milk for oral care under antibiotic therapy are excluded; 10. Postnatal administration of intestinal probiotic agents.

Design outcomes

Primary

Measure	Time frame
High-throughput sequencing of the 16S rRNA variable region in stool samples.;	—

Secondary

Measure	Time frame
Length of hospital stay;	—

Countries

China

Contacts

Public ContactZhang Xinhua

Children's Hospital of Shanxi Province

sxswsjkwrsc@126.com+86 138 3510 7719

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026