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IRCT20160120026115N7 IRCT 2022-01-17 Iran University of Medical Sciences Effect of hydrolyzed formula and standard formula in the first two weeks of life in preterm infants Comparative study of the effect of hydrolyzed formula and standard formula in the first two weeks of life in preterm infants less than 34 weeks on improving nutritional tolerance and the prevalence of necrotizing enterocolitis. 2020-11-21 anticipated 104 Complete https://irct.ir/trial/59757 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization in this study is done by simple randomization method using Rand function of Excel software. First, 104 random numbers are created in a column using the Rand function. Then in the second column, from the numbers one to 104, new columns are inserted in front of each random code. Finally, in the third column, 52 lines are filled with code A and 52 lines with code B are filled. After arranging the size of the first column numbers using the software, by maintaining their connection to the second and third column numbers, a random sequence in the third column is ready. The numbers in the second column, each assigned to one of two groups based on the corresponding row in the third column, can be used as the row code used in hiding, Blinding description: The powdered milk of both groups are packed in containers of the same shape and after preparing a random list by a person outside the executing group and receiving the interventions, they are labeled based on the codes obtained in randomization. The sequence of random codes will be hidden from this person (or the principal investigator's representative for blindness) until the end of the study, and will only be opened at the request of the principal investigator if necessary to avoid endangering the lives of the volunteers. 3 Necrotizing enterocolitis. Intervention 1: In the intervention group, the hydrolyzed formula is used for feeding in all meals. The hydrolyzed formula in all members of the intervention group was from the same brand (Aptamil / Nutricia).How to prepare milk powder according to the manufacturer's instructions was one measure per 30 cc of water. Intervention 2: Control group: The regular formula is used for feeding in all meals. The regular formula in all members of the intervention group was from the same brand (Aptamil / Nutricia). How to prepare milk powder according to the manufacturer's instructions was one measure per 30 cc of water. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentifiable individuals When: The access period starts one year after the results are published. To whom: Researchers working in academic institutions Conditions: The data are allowed for further studies on this research topic. Where to obtain: Leila Irani/ Iran University of Medical Sciences/ Iran University of Medical Sciences, Hemmat highway/ or Email address: kashakimd@gmail.com How to obtain: Written request or email Comments:
public Mandana Kashaki
Shahid Akbar Abadi Hospital; molavi Ferdows Station; tehran
tehran Iran (Islamic Republic of) 1494868871 +98 21 5563 2277 kashakimd@gmail.com Iran University of Medical Sciences scientific Mandana Kashaki
hemmat high way, Tehran
Tehran Iran (Islamic Republic of) 1494868871 +98 21 5563 2277 kashakimd@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Infants less than 34 weeks gestationally deprived of breast milk Infants without underlying congenital disorders 1 day 14 days Both Infants were excluded from the study with parental dissatisfaction. Infants from addicted parents were excluded from the study. Infants with asphyxia were excluded from the study. Infants with a fifth minute Apgar score of less than seven were excluded from the study. Infants with IUG-R were excluded from the study. Infants with congenital anomalies were excluded from the study. P77.9 Necrotizing enterocolitis in newborn, unspecified Prevention N/A In the intervention group, the hydrolyzed formula is used for feeding in all meals. The hydrolyzed formula in all members of the intervention group was from the same brand (Aptamil / Nutricia).How to prepare milk powder according to the manufacturer's instructions was one measure per 30 cc of water. Control group: The regular formula is used for feeding in all meals. The regular formula in all members of the intervention group was from the same brand (Aptamil / Nutricia). How to prepare milk powder according to the manufacturer's instructions was one measure per 30 cc of water. Improvement in nutritional tolerance. Timepoint: From the start of feeding the baby to the time of discharge from the hospital. Method of measurement: Clinical examination corresponding to the disease. Reducing the incidence of necrotizing enterocolitis in premature infants. Timepoint: From the start of feeding the baby to the time of discharge from the hospital. Method of measurement: Clinical and laboratory examination corresponding to the disease. Duration of hospital stay. Timepoint: From the start of feeding the baby to the time of discharge from the hospital. Method of measurement: Number of days of hospitalization based on the contents of the file. Sepsis. Timepoint: From the start of feeding the baby to the time of discharge from the hospital. Method of measurement: Positive blood culture. Iran University of Medical Sciences Approved 2020-07-22 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Hemmat highway Tehran Tehran Iran (Islamic Republic of)