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Study aim
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The effect of oral-pharyngeal breastfeeding until the onset of oral feeding in premature infants on nutritional outcomes
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Design
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Excel software rand function was used to randomize a clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 80 infants.
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Settings and conduct
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Infants of 30-25 weeks were admitted to the NICU of Amir Al-Momenin Hospital in Semnan. Each infant will be randomly assigned to the breast milk group or placebo in a ratio of 1: 1. Using aseptic techniques, one researcher prepares insulin syringes with 0.1 ml of sterile BM or distilled water. The syringes are covered with a matte coating to prevent them from becoming blind. The baby's name is placed on the syringe, and a separate box is placed to store the milk syringes of each baby in the refrigerator and maintain the box blindness for the babies in the control group. Each infant will receive 0.2 ml of BM or sterile distilled water every 2 hours until the start of oral feeding, regardless of intestinal milk intake. At each turn, the contents of a syringe are poured to the right of the oral cavity. After 30 s, the contents of the second syringe are poured to the left.
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Participants/Inclusion and exclusion criteria
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Infants with a gestational age of 25-30 weeks and infants with congenital malformations of the gastrointestinal tract, urinary, renal systems or need a ventilator, a history of substance abuse or HIV infection in the mother, and mothers who are not breastfed are excluded.
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Intervention groups
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Starting 48 to 72 hours after the birth of each baby, every two hours, warm each syringe for 5 minutes in the incubator and then pour the contents of one syringe to the right of the oral cavity and after 30 s, pour the contents of the second syringe to the left.
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Main outcome variables
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Lavage, time of discharge from hospital, the onset of intestinal feeding, and oral feeding.