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IRCT20180427039436N12 IRCT 2021-12-14 Iran University of Medical Sciences The effect of oral consumption of lettuce syrup on breast milk volume and weight gain of preterm infants The effect of oral consumption of lettuce syrup on breast milk volume and weight gain of preterm infants 2022-01-21 anticipated 144 Complete https://irct.ir/trial/59620 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Samples that were continuously included in the study will be randomly assigned by six blocks in a one-to-one ratio in the three experimental, placebo, and control groups. For random assignment of people in three groups, the random blocking method from https://www.sealedenvelope.com/ is used. A person outside the research team prepares a random list of people and the code of consumed syrups through the site https://www.sealedenvelope.com/ (information needed to achieve random allocation and concealment of research samples including the number of treatment groups (treatment groups), the number of blocks and the size of each (block sizes), the number of people participating in the study, determine the need for a coding code for each participant (generate unique randomization code). The site issues a two-digit code and a number for each sample, which specifies exactly which block and for which group the sample is from. The package and the sample we want are known by the code and number inserted), Blinding description: There is no possibility of blinding in the present study due to having a control group and only to increase the accuracy of the study, the researcher will not know the content of syrup given to individuals in each group. 3 The effet of oral consumption of Lactuca sativa syrup on breast milk volume and weight gain of preterm infant. Intervention 1: Intervention group: Mothers in the experimental group will receive a 240 ml Lactuca sativa syrup. In this research, 240 ml of Lactuca sativa syrup (Noma) made by Sanabel Daroo Company, with Iran Food and Drug Code with registration number "0545 -95-S" will be used. Lettuce syrup is based on total phenol, containing at least 10 mg per 10 gr of standard syrup. They are advised to consume one tablespoon 3 times a day, half an hour after breakfast, lunch and dinner for a week. The researcher teaches mothers how to use a breast pump by placing a flange, which is the breast protector, on their nipple.Turn on the machine and allow the milk to be sucked and poured into a container attached to the milking parlor. It takes between 10 and 15 minutes to pump both breasts with a good electric milking machine. good milking machine simulates baby sucking and does not cause pain. At first, mothers may feel a lot of traction from their automatic breastfeeding, so it is best to start with the lowest degree of suction And increase the degree as needed during the habit. It will also teach them to be calm and comfortable, first wash their hands before starting to milk and do not forget to carefully clean the parts of the machine after each use of the milk. The hospital milking machine is provided to mothers. Breastfeeding using Medla Electronic milking machine is performed by the mother on waking at least 6 times in 12 hours during a 7 day study period for 15 minutes on both breasts and The milk is poured into a container attached to the milking machine. All mothers are instructed to count the number and time spent breast pumping daily (in minutes), the volume of breast milk at each pumping, the time spent skin-to-skin contact (kangaroo care) with their premature baby, Manually, enter the daily information registration form within 7 days. The trained researcher or assistant researcher will also record the type and amount of serum consumed in the daily information form in the case of neonatal serum therapy. Mothers give their milk to their premature infants (under 32 weeks) according to the doctor's instructions, and If there is a lot of milk and more than the infant needs, according to the mother's consent, in completely standard conditions, they will store it in the milk bank of Shahid Akbarabadi Hospital or Is thrown away. Intervention 2: Intervention group: Mothers in the placebo group will receive a placebo syrup based on the syrup base formula (meaning the syrup base, sugar, and color combinations to simulate Lactuca sativa syrup).In this research, 240 ml placebo syrup made by Sanabel Daroo Company, made in Iran, is used.They are advised to consume one tablespoon 3 times a day, half an hour after breakfast, lunch and dinner for a week.The researcher teaches mothers how to use a breast pump by placing a flange, which is the breast protector, on their nipple.Turn on the machine and allow the milk to be sucked and poured into a container attached to the milking parlor. It takes between 10 and 15 minutes to pump both breasts with a good electric milking machine. good milking machine simulates baby sucking and does not cause pain. At first, mothers may feel a lot of traction from their automatic breastfeeding, so it is best to start with the lowest degree of suction And increase the degree as needed during the habit. It will also teach them to be calm and comfortable, first wash their hands before starting to milk and do not forget to carefully clean the parts of the machine after each use of the milk. The hospital milking machine is provided to mothers. Breastfeeding using Medla Electronic milking machine is performed by the mother on waking at least 6 times in 12 hours during a 7 day study period for 15 minutes on both breasts and The milk is poured into a container attached to the milking machine. All mothers are instructed to count the number and time spent breast pumping daily (in minutes), the volume of breast milk at each pumping, the time spent skin-to-skin contact (kangaroo care) with their premature baby, Manually, enter the daily information registration form within 7 days. The trained researcher or assistant researcher will also record the type and amount of serum consumed in the daily information form in the case of neonatal serum therapy. Mothers give their milk to their premature infants (under 32 weeks) according to the doctor's instructions, and If there is a lot of milk and more than the infant needs, according to the mother's consent, in completely standard conditions, they will store it in the milk bank of Shahid Akbarabadi Hospital or Is thrown away. Intervention 3: Control group: Mothers in the control group will not receive any herbal or chemical formula. The researcher teaches mothers how to use a breast pump by placing a flange, which is the breast protector, on their nipple.Turn on the machine and allow the milk to be sucked and poured into a container attached to the milking parlor. It takes between 10 and 15 minutes to pump both breasts with a good electric milking machine. good milking machine simulates baby sucking and does not cause pain. At first, mothers may feel a lot of traction from their automatic breastfeeding, so it is best to start with the lowest degree of suction And increase the degree as needed during the habit. It will also teach them to be calm and comfortable, first wash their hands before starting to milk and do not forget to carefully clean the parts of the machine after each use of the milk. The hospital milking machine is provided to mothers. Breastfeeding using Medla Electronic milking machine is performed by the mother on waking at least 6 times in 12 hours during a 7 day study period for 15 minutes on both breasts and The milk is poured into a container attached to the milking machine. All mothers are instructed to count the number and time spent breast pumping daily (in minutes), the volume of breast milk at each pumping, the time spent skin-to-skin contact (kangaroo care) with their premature baby, Manually, enter the daily information registration form within 7 days. The trained researcher or assistant researcher will also record the type and amount of serum consumed in the daily information form in the case of neonatal serum therapy. Mothers give their milk to their premature infants (under 32 weeks) according to the doctor's instructions, and If there is a lot of milk and more than the infant needs, according to the mother's consent, in completely standard conditions, they will store it in the milk bank of Shahid Akbarabadi Hospital or Is thrown away. 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 Due to the fact that the study and studies have not been done, no decision has been made in this regard.
public Leila Amirifarahani
In front of Khatamol anbiaa Hospital., Rashid Yasemi Ave., Valiasr Ave.,Tehran Town
Tehran Iran (Islamic Republic of) 1996713883 +98 21 4365 1139 L.amirifarahani@gmail.com Iran University of Medical Sciences scientific Iran University of Medical Sciences
In front of Khatamol anbiaa Hospital., Rashid Yasemi Ave., Valiasr Ave.,Tehran Town
Tehran Iran (Islamic Republic of) 1996713883 +98 21 4365 1139 L.amirifarahani@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) have minimum 18 years old Mother's ability to read and write Have normal maternal body mass index (18/5 - 24/9 kg / m2) mothers interest to exclusive breastfeeding mothers interest to pumping breasts witt electronic pumping from third day of postpartum presence of the mother in the hospital during the study Preterm infant with gestational age less than 32 weeks Infant hospitalization in NICU fed with NG tube 8 months 8 months Both Use of cigarette, alcohole and drugs Use of any galactagogue and complementary drug History of infertility Affiliction of mother to infectious transferable diseases from lactating such as HIV and active pulmonary tuberculosis Diabetic mother Mothers with cancer related to estrogen Mother use of anticoagulants Mother use of psychiatric drugs Breast problems such as abscesses, inverted nipples, mastitis or cancer Breast surgery Existence of congenital anomalies such as cleft palate and cleft lip Supplementation by the infant Twin or multiple infants P07.3 Preterm [premature] newborn [other] Other Other Other Intervention group: Mothers in the experimental group will receive a 240 ml Lactuca sativa syrup. In this research, 240 ml of Lactuca sativa syrup (Noma) made by Sanabel Daroo Company, with Iran Food and Drug Code with registration number "0545 -95-S" will be used. Lettuce syrup is based on total phenol, containing at least 10 mg per 10 gr of standard syrup. They are advised to consume one tablespoon 3 times a day, half an hour after breakfast, lunch and dinner for a week. The researcher teaches mothers how to use a breast pump by placing a flange, which is the breast protector, on their nipple.Turn on the machine and allow the milk to be sucked and poured into a container attached to the milking parlor. It takes between 10 and 15 minutes to pump both breasts with a good electric milking machine. good milking machine simulates baby sucking and does not cause pain. At first, mothers may feel a lot of traction from their automatic breastfeeding, so it is best to start with the lowest degree of suction And increase the degree as needed during the habit. It will also teach them to be calm and comfortable, first wash their hands before starting to milk and do not forget to carefully clean the parts of the machine after each use of the milk. The hospital milking machine is provided to mothers. Breastfeeding using Medla Electronic milking machine is performed by the mother on waking at least 6 times in 12 hours during a 7 day study period for 15 minutes on both breasts and The milk is poured into a container attached to the milking machine. All mothers are instructed to count the number and time spent breast pumping daily (in minutes), the volume of breast milk at each pumping, the time spent skin-to-skin contact (kangaroo care) with their premature baby, Manually, enter the daily information registration form within 7 days. The trained researcher or assistant researcher will also record the type and amount of serum consumed in the daily information form in the case of neonatal serum therapy. Mothers give their milk to their premature infants (under 32 weeks) according to the doctor's instructions, and If there is a lot of milk and more than the infant needs, according to the mother's consent, in completely standard conditions, they will store it in the milk bank of Shahid Akbarabadi Hospital or Is thrown away. Intervention group: Mothers in the placebo group will receive a placebo syrup based on the syrup base formula (meaning the syrup base, sugar, and color combinations to simulate Lactuca sativa syrup).In this research, 240 ml placebo syrup made by Sanabel Daroo Company, made in Iran, is used.They are advised to consume one tablespoon 3 times a day, half an hour after breakfast, lunch and dinner for a week.The researcher teaches mothers how to use a breast pump by placing a flange, which is the breast protector, on their nipple.Turn on the machine and allow the milk to be sucked and poured into a container attached to the milking parlor. It takes between 10 and 15 minutes to pump both breasts with a good electric milking machine. good milking machine simulates baby sucking and does not cause pain. At first, mothers may feel a lot of traction from their automatic breastfeeding, so it is best to start with the lowest degree of suction And increase the degree as needed during the habit. It will also teach them to be calm and comfortable, first wash their hands before starting to milk and do not forget to carefully clean the parts of the machine after each use of the milk. The hospital milking machine is provided to mothers. Breastfeeding using Medla Electronic milking machine is performed by the mother on waking at least 6 times in 12 hours during a 7 day study period for 15 minutes on both breasts and The milk is poured into a container attached to the milking machine. All mothers are instructed to count the number and time spent breast pumping daily (in minutes), the volume of breast milk at each pumping, the time spent skin-to-skin contact (kangaroo care) with their premature baby, Manually, enter the daily information registration form within 7 days. The trained researcher or assistant researcher will also record the type and amount of serum consumed in the daily information form in the case of neonatal serum therapy. Mothers give their milk to their premature infants (under 32 weeks) according to the doctor's instructions, and If there is a lot of milk and more than the infant needs, according to the mother's consent, in completely standard conditions, they will store it in the milk bank of Shahid Akbarabadi Hospital or Is thrown away. Control group: Mothers in the control group will not receive any herbal or chemical formula. The researcher teaches mothers how to use a breast pump by placing a flange, which is the breast protector, on their nipple.Turn on the machine and allow the milk to be sucked and poured into a container attached to the milking parlor. It takes between 10 and 15 minutes to pump both breasts with a good electric milking machine. good milking machine simulates baby sucking and does not cause pain. At first, mothers may feel a lot of traction from their automatic breastfeeding, so it is best to start with the lowest degree of suction And increase the degree as needed during the habit. It will also teach them to be calm and comfortable, first wash their hands before starting to milk and do not forget to carefully clean the parts of the machine after each use of the milk. The hospital milking machine is provided to mothers. Breastfeeding using Medla Electronic milking machine is performed by the mother on waking at least 6 times in 12 hours during a 7 day study period for 15 minutes on both breasts and The milk is poured into a container attached to the milking machine. All mothers are instructed to count the number and time spent breast pumping daily (in minutes), the volume of breast milk at each pumping, the time spent skin-to-skin contact (kangaroo care) with their premature baby, Manually, enter the daily information registration form within 7 days. The trained researcher or assistant researcher will also record the type and amount of serum consumed in the daily information form in the case of neonatal serum therapy. Mothers give their milk to their premature infants (under 32 weeks) according to the doctor's instructions, and If there is a lot of milk and more than the infant needs, according to the mother's consent, in completely standard conditions, they will store it in the milk bank of Shahid Akbarabadi Hospital or Is thrown away. Determining breast milk volume. Timepoint: Measurement of breast milk volume on days 1, 2, 3, 4, 5, 6 and 7 of the study. Method of measurement: Measurement of milk volume in mothers through sweetheart medela AND. Determining weight gain of preterm infant. Timepoint: Measurement of preterm infant weight on day one (before intervention), day three and day seven. Method of measurement: Measurement of weight of preterm infant through a Seca scale production of Germane. Pharmacological complication. Timepoint: During one week of study. Method of measurement: Mothers will notify the researcher whose telephone number is provided to the mothers if they notice any allergies or complications during the study.The researcher registers the complication in the drug side effects registration form and takes the appropriate action. Iran University of Medical Sciences Approved 2021-10-27 Ethics Committee of Iran University of Medical Sciences In front of Khatamol anbiaa Hospital., Rashid Yasemi Ave., Valiasr Ave.,Tehran Town Tehran Tehran Iran (Islamic Republic of)