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IRCT20221120056556N2 IRCT 2023-01-28 Shahid Beheshti University of Medical Sciences Effect of Docosahexaenoic Acid Supplementation on neonatal outcomes of pereterm infants DHA Effect of Docosahexaenoic Acid Supplementation on neonatal outcomes of pereterm infants 2022-12-22 anticipated 384 Complete https://irct.ir/trial/67187 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we will use the block randomization method. This method should be used in order to create a balance in the number of samples allocated to each groups and it helps the researchers in cases where there is a need to perform analysis during the sampling process, the number of samples allocated to Each of the studied groups should be equal. In this trial, we will have two groups of 4 blocks (BAAB), (ABBA), (AABB), (BBAB), (ABAB) (including 2 participants in the doxohexanoic acid group and 2 participants in the placebo group). Randomization will also be done using random sequence generation software (random allocation software). Based on the list of randomly prepared blocks of four, a trained person (clinical pharmacologist) outside the research team is responsible for randomly allocating patients, after each patient is admitted to the special ward, according to the block of four prepared in the first stage. Each patient will be randomly assigned to A) intervention) or B) placebo group) and the sampling process will be carried out consecutively until the end of sampling, the code of each patient will also be assigned to his family member. People are assigned to the desired group in the order of their entry into the study and randomly through randomized blocks, and this process continues until the selection of the last block, Blinding description: Products that encoded to drug and placebo by clinical pharmacist, will be prescribe for infants by blinded neonatologist. Then a blinded nurse will administrate the products. Our blinded coauthors who is responsible for outcome assessment and other statistical analyzer will be evaluate the outcomes and results. 3 Nutrition of premature babies / Growth of premature babies / Prognosis of premature babies. Intervention group:Premature babies are divided into intervention and placebo groups using a random number table. So that the people who met the conditions to enter the study will be treated by pre-coded pharmaceutical and placebo products prepared by the clinical pharmacist and the doctor and nurse of the ward have no knowledge of their original nature. The baby receives 60 cc/kg of milk enterally, starting and continuing for 14 days. If the baby is discharged from the ward earlier than 14 days, it will be excluded from the study. In both the intervention and control groups, available emulsions (including placebo and DHA) based on the weight of the baby with a dose of 0.5 cc/kg/day (as daily or every twelve hours based on the baby's tolerance) will be prescribed. During the daily visit, the request for the implementation of the intervention for 14 days will be included in the doctor's request sheet by the neonatologist. It will be given to the baby before feeding with breast milk and through gavage. It should be mentioned that DHA and placebo emulsion are similar in terms of color, volume and taste. Then, the growth indicators during the intervention period are daily and after completion. He will be evaluated weekly until he is discharged from the hospital and also after discharge in follow-up clinics on a monthly basis, and the relevant checklists will be completed.More about this source textSource text required for additional translation informationSend feedbackSide panels. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Minoo Fallahi
7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.
Tehran Iran (Islamic Republic of) 19839-63113 +98 21 2243 9770 minoofallahi@yahoo.com Shahid Beheshti University of Medical Sciences scientific Minoo Fallahi
7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.
Tehran Iran (Islamic Republic of) 19839-63113 +98 21 2243 9770 minoofallahi@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Preterm infants with gestational age less than 34 weeks. Birth weight less than 2000 gr. 1 day 30 days Both Infants need to major surgery Infants with major congenital anomalies Exclusively formula fed infants Discharge to home on less than 14th day of life Infants of mother whit special treatment diet Treatment - Drugs Intervention group:Premature babies are divided into intervention and placebo groups using a random number table. So that the people who met the conditions to enter the study will be treated by pre-coded pharmaceutical and placebo products prepared by the clinical pharmacist and the doctor and nurse of the ward have no knowledge of their original nature. The baby receives 60 cc/kg of milk enterally, starting and continuing for 14 days. If the baby is discharged from the ward earlier than 14 days, it will be excluded from the study. In both the intervention and control groups, available emulsions (including placebo and DHA) based on the weight of the baby with a dose of 0.5 cc/kg/day (as daily or every twelve hours based on the baby's tolerance) will be prescribed. During the daily visit, the request for the implementation of the intervention for 14 days will be included in the doctor's request sheet by the neonatologist. It will be given to the baby before feeding with breast milk and through gavage. It should be mentioned that DHA and placebo emulsion are similar in terms of color, volume and taste. Then, the growth indicators during the intervention period are daily and after completion. He will be evaluated weekly until he is discharged from the hospital and also after discharge in follow-up clinics on a monthly basis, and the relevant checklists will be completed.More about this source textSource text required for additional translation informationSend feedbackSide panels Determining the effect of Docosahexaenoic acid on the growth indices of premature infants. Timepoint: During the study, the growth indices will be checked daily to measure weight and weekly to measure height and head circumference, and they will be checked until the time the baby is admitted to the hospital. Method of measurement: A scale will be used to measure weight and a meter will be used to measure height. Investigating the effect of Docosahexaenoic acid on the incidence of intraventricular hemorrhage in preterm infants. Timepoint: During the whole time of the baby's stay in the hospital. Method of measurement: With brain ultrasonography. Investigating the effect of Docosahexaenoic acid acid acids on the incidence of neonatal sepsis in preterm infants. Timepoint: During the whole time of the baby's stay in the hospital. Method of measurement: Clinical finding and blood culture examination. Investigating the effect of Docosahexaenoic acids on the incidence of neonatal necrotizing enteroculitis in preterm infants. Timepoint: During the whole time of the baby's stay in the hospital. Method of measurement: clinical and radiological findings. Investigating the effect of Docosahexaenoic acids on the incidence of retinopathy of prematurity in preterm infants. Timepoint: During the whole time of the baby's stay in the hospital. Method of measurement: Based on the retinal exam by ophthalmologist. Shahid Beheshti University of Medical Sciences Approved 2022-07-07 Ethics committee of Shahid Beheshti University of Medical Sciences 7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)