Oral Care With Colostrum for Preventing Late-onset Sepsis in Preterm Infants

General Organization for Teaching Hospitals and Institutes

Status: Completed

Conditions: Prematurity

Treatments: Other: Placebo; Other: Mother's colostrum

Study type: Interventional

Funder types: Other

Identifiers

NCT06534632

HM000142

Details and patient eligibility

About

This clinical trial aimed to evaluate the efficacy of the oral mother's colostrum administration for preventing late-onset sepsis in premature neonates during their stay in the neonatal intensive care unit. The investigators hypothesized that premature infants who receive oral mother's colostrum would have a lower incidence of late-onset sepsis and better hospital outcomes, compared to infants who receive a placebo.

Full description

The study was a randomized clinical trial, performed on very-low-birthweight premature newborns admitted to the neonatal intensive care unit of Mataria Teaching Hospital after considering exclusion criteria.

The enrolled newborns were randomly subdivided into two groups (1:1). The colostrum group received their mother's colostrum, and the placebo group received placebo (sterile water) using a standardized protocol. The newborns received 0.2 mL of the colostrum or placebo orally using a swab directed backward into the oropharynx (0.1 mL on either side of the oral cavity), starting during the first 24 hours of life and lasting for 5 days. Vital signs were carefully monitored throughout the procedure. Dosing was provided every 6 hours during the study period.

All infants underwent follow-up from birth until discharge or death whichever came first. Neonates were evaluated for occurrence of late-onset sepsis, death, and other clinical outcomes.

Enrollment: 65 patients

Sex: All

Ages: 1 to 24 hours old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Very-low-birth-weight preterm newborns admitted to the neonatal intensive care unit within 24 hours after delivery
• Neonates with gestational age ≤ 34 weeks and weight ≤ 1500 grams

Exclusion criteria

• Infants with severe gastrointestinal malformations.
• Infants with serious congenital anomalies or chromosomal abnormalities.
• Infants with signs of early-onset sepsis.
• Any contraindications for breastfeeding because of maternal conditions including active tuberculosis or AIDS, or treatment with medications excreted in breast milk.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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65 participants in 2 patient groups, including a placebo group

Colostrum group

Experimental group

Description:

The interventional group received their mother's colostrum through the oropharyngeal route beginning within the first 24 hours of birth and for 5 days at a dose of 0.2 mL/6 hours

Treatment:

Other: Mother's colostrum

Placebo group

Placebo Comparator group

Description:

The placebo group received sterile water through the oropharyngeal route beginning in the first 24 hours of birth and for 5 days at a dose of 0.2 mL/6 hours

Treatment:

Other: Placebo