Effect of oropharyngeal milk administration on the oral and gut microbiota of very low birth weight infant: Randomized controlled trial

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

TCTR

Registry ID

TCTR20180306002

Enrollment

100

Registered

2018-03-06

Start date

2018-07-01

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Preterm infant Oral care Microbiota Gastrointestinal Microbiome Microbiota Oral immune therapy Oropharyngeal milk Very low birth weight infant

Interventions

Nurses will give 0.1 mL of breast milk into each buccal pouch every 3 hours until 28th date of postnatal age or the neonate will be oral fed (breastfeed or bottom feed) by themselves&#44

whichever comes first. ,Nurses will give 0.1 mL of sterile water into each buccal pouch every 3 hours until 28th date of postnatal age or the neonate will be oral fed (breastfeed or bottom feed) by th

whichever comes first.

Experimental Dietary Supplement,Placebo Comparator Other

Oropharyngeal milk,Sterile water

Eligibility

Sex/Gender

All

Age

1 Days to 28 Days

Inclusion criteria

Inclusion criteria: 1 Very low birth weight neonate (birth weight less than 1,500 grams) 2 Inborn neonate

Exclusion criteria

Exclusion criteria: 1 Maternal death 2 Contraindication of breast milk eg maternal HIV infection 3 Gut anomalies 4 Chromosome abnormality or moribund

Design outcomes

Primary

Measure	Time frame
Oral and gut microbiota Oral feed (oral) or 28 days of life (gut) NextGen	—

Secondary

Measure	Time frame
Clinical outcomes until death or discharge record form	—

Countries

Thailand

Contacts

Public ContactAnucha Thatrimontrichai

Prince of Songkla University

tanucha@medicine.psu.ac.th075451257

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026