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IRCT20220424054629N1 IRCT 2023-05-09 Shahid Beheshti University of Medical Sciences The relationship between oropharyngeal administration of breast milk and early outcomes in premature infants with a birth weight of less than 1500 grams. The relationship between oropharyngeal administration of breast milk and early outcomes in premature infants with a birth weight of less than 1500 grams. 2023-06-22 anticipated 70 Complete https://irct.ir/trial/63151 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. N/A Condition 1: Necrotizing enterocolitis. Condition 2: oral colostrum. Condition 3: Neonatal sepsis. Condition 4: Retinopaty of prematurity. Condition 5: Intraventricular hemorrhage. Condition 6: Bronchopulmonary dysplasia. Condition 7: Neonatal death. Condition 8: ventilator associated pneumonia. Intervention 1: Intervention group: In this group, babies will receive 8 drops equivalent to 0.2 cc of warm milk expressed by their mother every 3 hours. This amount of milk will be dripped 4 drops on each side of the mouth by the baby nurse with a 1 cc needle less syringe. This milk will be separate from the amount of milk that the baby will receive by gavage with feeding tube on a routine basis for feeding, usually from the third day of birth. This intervention will continue until the baby starts oral feeding.That is, when the baby is able to receive milk directly through the mouth and not by gavage. Intervention 2: Control group: In this group of infants, according to common care, they will not receive any milk by mouth until the start of oral feeding. Of course, this intervention will be separate from the volume of milk, which will be received routinely for feeding, usually from the third day of the baby's birth, in the form of gavage with a feeding tube. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No decision has been made yet
public Sedigheh Tehranchi
Tajrish sq,Shariati st,Tehran,Iran
Tehran Iran (Islamic Republic of) 1989934148 +98 21 25719 drsedighehtehranchi@gmail.com Shahid Beheshti University of Medical Sciences scientific Sedigheh Tehranchi
Tajrish sq,Shariati st,Tehran,Iran
Tehran Iran (Islamic Republic of) 1989934148 +98 21 25719 drsedighehtehranchi@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) no sever congenital anomalies birth weight below 1500 gr capability of protocol administration in the first 96 hours 1 day no limit Both Congenital Anomalies Gastrointestinal problems that are for contraindication to nutrition, such as esophageal atresia Neonatal asphyxia Maternal HIV infection Maternal history of substance abuse Triple gestation or more Treatment - Other Treatment - Other Intervention group: In this group, babies will receive 8 drops equivalent to 0.2 cc of warm milk expressed by their mother every 3 hours. This amount of milk will be dripped 4 drops on each side of the mouth by the baby nurse with a 1 cc needle less syringe. This milk will be separate from the amount of milk that the baby will receive by gavage with feeding tube on a routine basis for feeding, usually from the third day of birth. This intervention will continue until the baby starts oral feeding.That is, when the baby is able to receive milk directly through the mouth and not by gavage. Control group: In this group of infants, according to common care, they will not receive any milk by mouth until the start of oral feeding. Of course, this intervention will be separate from the volume of milk, which will be received routinely for feeding, usually from the third day of the baby's birth, in the form of gavage with a feeding tube. Neonatal death. Timepoint: During hospitalization. Method of measurement: Clinical documentation. Neonatal Sepsis. Timepoint: During hospitalization. Method of measurement: Clinical and paraclinic documentation. Retinopathy of prematurity. Timepoint: During hospitalization. Method of measurement: Physical examination. Intraventricular hemorrhage. Timepoint: During hospitalization. Method of measurement: Brain sonography. Ventilator associated pneumonia. Timepoint: During hospitalization. Method of measurement: Clinical and paraclinical documentaion. Time to reach fullfeed. Timepoint: During hospitalization. Method of measurement: Clinical documentaion. Necrotizing entrocolitis. Timepoint: During hospitalization. Method of measurement: Clinical documentaion. Hospitalization duration. Timepoint: During hospitalization. Method of measurement: Clinical doccumenation. Oral colostrom intake. Timepoint: During the first 96 hours of life. Method of measurement: Clinical documentation. Bronchopulmonary dysplaisa. Timepoint: During hospitalization. Method of measurement: Clinical and paraclinic documentation. Shahid Beheshti university of medical sciences Approved 2021-02-21 Ethics committee of Shahid Beheshti University of Medical Sciences Shahid Beheshti University of medical sciences .Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)