The relationship between oropharyngeal administration of breast milk and early outcomes in premature infants with a birth weight of less than 1500 grams.

Comparison of early outcomes due to oropharyngeal administration or non-administration of breast milk in premature infants admitted to the neonatal intensive care unit

A clinical trial with case and control group, single-blind, randomized, on 70 patients. RAS software is used for randomization.

This study will be conducted in a single blind way in the neonatal intensive care unit of Mahdieh Hospital in Tehran. In the intervention group, 8 drops of mother's expressed milk will be dripped on the sides of the oral mucosa every 3 hours. The intervention will continue until the start of oral feeding. The control group will not receive this milk in this way. Due to the type of intervention and lack of placebo, blinding will be done only for the group of outcome assessors and data analysts.

All very low birth weight infants admitted to the NICU are enrolled. Inclusion criteria are the absence of severe maternal malformations, weighing less than 1,500 grams, the ability to start our protocol in the first 96 hours of life Exclusion criteria are congenital anomalies and gastrointestinal problems that are contraindicated in nutrition, such as esophageal atresia, as well as asphyxia in infants, maternal AIDS, maternal substance abuse, and triplets or more

The intervention group is given oral colostrum according to the protocol from the first day of birth until the start of oral feeding, and the control group is not given oral milk until the start of oral feeding

Intraventricular hemorragea, Bronchopulmonary dysplasia, Ventilator-induced pneumonia, Premature retinopathy, Sepsis, Duration of hospitalization, Death, Necrotizing enterocolitis, Duration to reach 150 cc per kilogram feed

The classification of the samples to be assigned to the treatment groups will be done in a block random manner. The randomization unit is considered individual. RAS statistical software, block randomization tool will also be used to determine the sequence of blocks. The sealed cover letter will be used for allocation concealment. We consider the capacity of the blocks as 4 and then we write all the possible permutations for this block, which are defined as follows. (1: ABAB) and (2: AABB) and (3: BBAA) and (4: BABA) and (5: ABBA) and (6: BAAB) By means of statistical software, we randomly select one of the numbers of permutations and consider the block corresponding to it. For example, if the first random selection of block 2 is selected, the first person will receive treatment A, the second person will receive treatment A, the third person will receive treatment B, and the fourth person will receive treatment B. To reach a sample size of 61 per group, we continue this sequence 30 times. After selecting all the blocks, we randomly assign indices B and A to one of the treatment groups.

It is not possible to blind the caregivers who drip milk into the baby's mouth (intervention group) and do not have this intervention (control group). Considering that this plan does not have a placebo, the baby's family will also know whether their baby is in the intervention group or the control group. The intervention and control group will be known as A and B, and only the data analyst and outcome assessor will not know whether A is the intervention group or the control.