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IRCT20220704055362N2 IRCT 2023-01-21 Shahid Beheshti University of Medical Sciences Comparison of Cue based Feeding and Volume Based Feeding on Blood Glucose of preterm infants Comparison of Cue based Feeding and Volume Based Feeding on Blood Glucose of preterm infants 2023-02-20 anticipated 122 Complete https://irct.ir/trial/67922 interventional Randomization: Randomized, Blinding: Not 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. N/A Condition 1: Hypoglycemia. Condition 2: Prematurity. Intervention 1: Control group: Feeding the baby will be done based on volume (usual method). A certain amount of milk (breast milk or formula) will be given to the baby every 2 to 3 hours according to the doctor's order. Intervention 2: Intervention group: Feeding the baby will be done based on the baby's behavioral cues. By observing the cues related to the baby's hunger, the baby will be fed with breast milk or formula, and as soon as the behavioral cues related to fullness appear, the feeding will be stopped. The amount and intervals of feeding will be determined by the baby. 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 There is no more information
public Elahe Rastkar Mehrabani
Shishe Gar khaneh Alley, Fadaian Islam Ave, Shoosh Sq, Tehran, Iran
Tehran Iran (Islamic Republic of) 1185817311 +98 21 5506 2628 e.rastkar@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Farzaneh Palizban
Shishe Gar khaneh Alley, Fadaian Islam Ave, Shoosh Sq, Tehran, Iran
Tehran Iran (Islamic Republic of) 1185817311 +98 21 5506 2628 palizbanfarzaneh@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Premature babies with a corrected age of 32 weeks and older Full enteral feeding has been tolerated and parentral nutrition has been discontinued Parental consent no limit no limit Both Need for invasive and/or non invasive mechanical ventilation Congenital abnormalities Gastrointestinal surgery Intra Ventricular Hemorrhage grade 3 or more Swallowing disorder Lack of parental consent E16.2 P07.30 Hypoglycemia, unspecified Preterm newborn, unspecified weeks of gestation Treatment - Other Treatment - Other Control group: Feeding the baby will be done based on volume (usual method). A certain amount of milk (breast milk or formula) will be given to the baby every 2 to 3 hours according to the doctor's order. Intervention group: Feeding the baby will be done based on the baby's behavioral cues. By observing the cues related to the baby's hunger, the baby will be fed with breast milk or formula, and as soon as the behavioral cues related to fullness appear, the feeding will be stopped. The amount and intervals of feeding will be determined by the baby. Blood glucose. Timepoint: From the time of entry into the study for 3 days with intervals of every 6 hours. Method of measurement: Capillary blood glucose test from the heel with a glucometer. Episodes of feeding intolerance. Timepoint: From the time of entering the study for 3 days, after each feeding (every 3 to 4 hours). Method of measurement: Report of caregiver (nurse/mother) and importing in the checklist. The rate of weight gain of neonates. Timepoint: From the time of entering the study till the day of discharge, daily assessment. Method of measurement: Weighing with a digital scale by the caregiver every morning. The number of days the baby is hospitalized. Timepoint: From the time of entering the study till the day of discharge, one time at discharge day. Method of measurement: Calculation of the number of days of hospitalization of the baby from the time of entering the study to the day of discharge. Baby's medical record. Shahid Beheshti University of Medical Sciences Approved 2023-01-01 Ethics Committee of Shahid Beheshti University of Medical Sciences Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)