Investigating the effect of Oropharyngeal colostrum in the prevention of late-onset sepsis in preterm infants admitted to neonatal intensive care unit by extraoral massage method

Determining the effect of colostrum orally-pharyngeal in the prevention of late-onset sepsis in premature infants admitted to the neonatal intensive care unit by extraoral massage method

Clinical trial with control group, with parallel groups, double-blind, randomized, on 70 babies, Random Allocation Software was used for randomization.

To conduct the study, the researcher referred to the special care department of Ayat Rohani Hospital in Babol and selected the eligible premature babies into two groups of 35. In the control group, 0.2 ml of mother's colostrum was administered as a mouthwash every 3 hours, and in the intervention group, 0.4 ml of mother's colostrum was administered orally every 3 hours for 7 days.

Inclusion criteria include premature infants with a gestational age between 28 and 32 weeks, premature infants without congenital abnormalities (gastrointestinal disorders) or genetic syndromes, premature infants without mechanical ventilation, the infant being NPO, not having premature sepsis or not having sepsis risk factors. Premature, the mother's lack of active viral infections during pregnancy and childbirth; Exclusion criteria include the condition of the infant not being stable during the intervention more than twice (loss of saturation, bradycardia,...), parents' refusal to continue the research project or death of infants before 7 days, infants needing urgent surgery.

In the control group, 0.2 ml of mother's ooze was poured as a mouthwash every 3 hours, and in the intervention group, 0.4 ml of ooze was applied (by oral-pharyngeal method) on the surface of the gums (buccal cavities), cheek, palate and the surface of the tongue. It is poured for 3 hours and each cheek is massaged from the outside of the mouth using the index finger.

late-onset sepsis

In this study, a parallel randomized controlled trial (parallel randomized controlled trial) considering that not all babies are included in the study at the same time and researchers cannot predict in advance which group each baby who is included in the study will belong to, for allocation Block randomization will be used to assign each baby to one of the two groups. In order to hide the random allocation, the codes created by the software will be placed in opaque envelopes so that it is not clear which group the next person will be assigned to. In order to hide the random allocation, the codes created by the software will be placed in opaque envelopes so that it is not clear which group the next person will be assigned to. In this study, the participating infants will be assigned to one of two control and intervention groups according to the random block division protocol (produced by Random Allocation Software) with a ratio of 1:1 and in blocks of 6, so that the researcher It cannot predict which intervention group the next person is placed in. The codes will be placed in the opaque envelopes, and with the entry of each new person, the envelope will be opened and the person's belonging to the relevant group will be determined.

Regarding the blinding method, this design is double-blind. In this study, the researcher and the nurses of the executive team are informed about the goals of the project and the groups, but the baby's parents, the evaluator (neonatal doctor) and the analyst (the person who performs the statistical analysis) are not aware of the groups.