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Administration of Mother's Colostrum to Premature Newborns.

Oropharyngeal Administration of Maternal Colostrum to Preterm Infants Targeting Neonatal Outcomes.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000644268
Enrollment
40
Registered
2018-04-23
Start date
2018-06-11
Completion date
2018-08-15
Last updated
2018-06-11

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

Conditions

None listed

Brief summary

The objective of this pilot study is to evaluate neonatal sepsis of premature infants after oropharyngeal administration of mother’s colostrum in neonatal intensive care unit (NICU). It is a randomized, controlled intervention. A total of 40 women with premature babies admitted to NICU will be recruited, where the neonates will receive 0.2 ml of colostrum or sterile water via oropharynx every 3 hours for 3 days. Milk and urine samples will be collected to analysis of the Human Milk Oligosaccharides by HPLC. The primary hypothesis of this study is that we will find a decreased incidence of neonatal sepsis in the intervention group. The secondary hypothesis is that we will find a higher concentration of Human Milk Oligosaccharides in the group with decreased incidence of neonatal sepsis.

Interventions

Neonates on group 1 receive 0.2 mL of own mother's colostrum administered by the nurse. Process: one syringe will be placed on the patient’s right or left buccal mucosa, and the colostrum drops will administered toward the posterior oropharynx for at least 10 seconds. Treatment period of every 3 hours for 72 consecutive hours. A member of the study staff will follow up periodically and randomly the colostrum administration.

Sponsors

Diana Bueno Gutierrez
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
27 Weeks to 37 Weeks
Healthy volunteers
No

Inclusion criteria

-Preterm Neonates: NICU admission less than or equal to 72 hours of life -Mother: 18 to 45 years old Desire to breast feed for at least 14 days

Exclusion criteria

-Preterm Neonates: Congenital diseases incompatible with life. Neonatal asphyxia. -Mothers: Lack of colostrum production within 48 hours after recruitment Contraindications for breastfeeding: drug addiction, diseases, HIV.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026