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IRCT20220505054746N1 IRCT 2022-08-04 Shahid Beheshti University of Medical Sciences The effect of early oral probiotics prescription in very low birth weight (VLBW) infants The effect of early oral probiotics prescription on feeding intolerance, regain birth weight and secondary outcomes in very low birth weight (VLBW) infants 2022-08-23 anticipated 300 Complete https://irct.ir/trial/63349 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Other, Purpose: Prevention, Randomization description: In order to homogenize the patients in terms of the intervening variables of mechanical ventilation (invasive-non-invasive) and type of nutrition (breast milk-formula) and to create a balance in the number of samples allocated to each of the studied groups, sampling method was used by random sampling. It is stratified block randomization. So that before starting the study, we first adjust the number of floors based on different levels of two qualitative variables. In this study, we will have 4 floors as follows. First class: patients who have aggressive ventilation and breast milk feeding. Second class: patients who have non-invasive ventilation and breast milk feeding. Third class: patients who have non-invasive ventilation and formula nutrition. Fourth class: patients who have aggressive ventilation and formula nutrition. We consider the sample size of each tier to be 75 to achieve a sample size of 300. For each class separately, we perform randomized block sampling. 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 a dice, we choose one of the numbers 1 to 6 and consider the corresponding block. For example, if the first random selection of block 5 is selected, the first person will receive treatment A, the second and third persons will receive treatment B, and the fourth person will receive treatment A. To reach a sample size of 75 per stratum, we continue this process 19 times. After selecting all the blocks, we randomly assign index A to one of the treatment groups. At the end, we merge the samples of all classes together and use the total sample for analysis, Blinding description: The placebo drop is used against the drug with the same packaging, with non -sequential coding for people who do not have access to the key. Parents of the neonate and doctor or indicator nurse have been blinded and will be contacted by the original researcher if needed, and at the end of the study and completion of the questionnaires, they will be identified by the code. 3 Condition 1: Very Low Birth Weight. Condition 2: 1_2.499 weight. Condition 3: feeding intolerance. Condition 4: Abdominal distension. Condition 5: vomiting. Condition 6: Digestive bleeding. Condition 7: necrotic enterocolitis. Condition 8: Sepsis. Intervention 1: Intervention group: early administration of oral probiotics in infants with very low birth weight. In this study, infants with very low birth weight from the first day of birth in the first 24 hours and once a day, before or after feeding with milk (in breastfeeding intervals) and for 14 days in the probiotic intervention group (containing Bifidobacterium lactis 3 5*100000000 colony forming units (CFU) and Bifidobacterium infantis 3.5*100000000 CFU and Streptococcus thermophilus 3*100000000 CFU) which is prepared in 700 mg sachets with maltodexerin and is 5 drops per day. It should be mentioned that this product is made by Farabiotic company. Intervention 2: Control group: administration of placebo in babies with very low birth weight. In this study, babies with very low birth weight from the first day of birth, in the first 24 hours and once a day, before or after feeding with milk (in breastfeeding intervals) and for 14 days in the control group, placebo (containing maltodextrin, which is The color, smell and taste are completely similar to the medicine) which is prepared in 700 mg sachets and is prescribed in the amount of 5 drops. It should be mentioned that this product is made by Farabiotic Company. Yes - There is a plan to make this available What will be shared: The main outcomes will be available. When: Six months after publishing. To whom: The data will be available per request for people working in academic institutions. Conditions: The data will available for using in systematic review and meta-analysis. Where to obtain: The data will be available by contacting email: naeemetaslimi@yahoo.com. How to obtain: The data will available for using in systematic review and meta-analysis. Comments:
public Fatemeh Heydari
Number 25, Andisheh 4 ave, Mollasadra St, Qazvin
Qazvin Iran (Islamic Republic of) 3415843899 +98 28 3367 3082 f.heydari@qums.ac.ir Shahid Beheshti University of Medical Sciences scientific Naeeme Taslimi Taleghani
Mahdiyeh Hospital, Shahid Rajabnia St, Shishegarkhaneh St, Shoosh square, Tehran, Iran
Tehran Iran (Islamic Republic of) 1185817311 +98 21 5506 2628 naeemetaslimi@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Hospitalization in NICU ward Born weight less than 1500 gr Stable hemodynamic status Ability to enteral nutrition Parent's written consent 1 day 2 days Both Dissatisfaction of parents Impossibility of starting standard nutrition for neonate Existence of any congenital anomalies in neonate Neonate's CPR need in labor room Unstable clinical status Being a child of mothers with substance abuse disorders Severe abdominal distension or peptic hemorrhage Immunodeficiency in the family of neonate Congenital enteral perforation or atresia Complete forbidding of oral feeding P07.0 P07.1 P92.5 Extremely low birth weight newborn Other low birth weight newborn Neonatal difficulty in feeding at breast P14 P11 P54.3 P77 P36.9 Prevention Placebo Intervention group: early administration of oral probiotics in infants with very low birth weight. In this study, infants with very low birth weight from the first day of birth in the first 24 hours and once a day, before or after feeding with milk (in breastfeeding intervals) and for 14 days in the probiotic intervention group (containing Bifidobacterium lactis 3 5*100000000 colony forming units (CFU) and Bifidobacterium infantis 3.5*100000000 CFU and Streptococcus thermophilus 3*100000000 CFU) which is prepared in 700 mg sachets with maltodexerin and is 5 drops per day. It should be mentioned that this product is made by Farabiotic company. Control group: administration of placebo in babies with very low birth weight. In this study, babies with very low birth weight from the first day of birth, in the first 24 hours and once a day, before or after feeding with milk (in breastfeeding intervals) and for 14 days in the control group, placebo (containing maltodextrin, which is The color, smell and taste are completely similar to the medicine) which is prepared in 700 mg sachets and is prescribed in the amount of 5 drops. It should be mentioned that this product is made by Farabiotic Company. Feeding intolerance. Timepoint: In each feeding time. Method of measurement: Checklist. Sepsis. Timepoint: Daily. Method of measurement: Based on having clinical and specific symptoms of sepsis (including irritability of the baby, rapid breathing or apnea, changes in the skin color of the baby, diarrhea, poor sucking, poor feeding) and positive result of blood culture and CRP result recorded in the checklist in daily evaluations. Necrotic Enterocolitis. Timepoint: Daily. Method of measurement: Based on having clinical and specific symptoms of Necrotizing Enterocolitis (including lethargy, increased volume of food residue, bloody or bilious vomiting, ileus, persistent abdominal distension, bloody stools, symptoms of peritonitis and shock) and the Bells scale, which is evaluated in the checklist designed by the researcher. Time of hospitalization. Timepoint: Daily. Method of measurement: Checklist. Time to reach total nutrition. Timepoint: Daily. Method of measurement: The days required to reach enteral nutrition of 100 milliliter per kilogram per day are evaluated with the checklist made by the researcher. Reach to born weight. Timepoint: Daily. Method of measurement: The weight of the infant will be assessed in terms of grams (in grams) until the clinical condition stabilizes and then daily until the day of discharge from the hospital. At the end of the weighting process, each premature infant will be assessed using Fenton growth charts. All measurements will be performed with a digital scale for fixed infants with the help of a researcher and will be recorded in a checklist created by the researcher. Shahid Beheshti University of Medical Sciences Approved 2022-02-06 Ethics committee of Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical Sciences, Velenjak Blvd., Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)