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IRCT20150424021917N11 IRCT 2020-12-22 Vice Chancellor for Research and Technology University of Medical Sciences Effect of cup, syringe and finger feeding on timing of complete oral feeding and weight gain in preterm infants: a randomized controlled clinical trial Comparison of the effect of cup, syringe and finger feeding on timing of complete oral feeding and weight gain in preterm infants: a randomized controlled clinical trial 2020-12-21 anticipated 99 Complete https://irct.ir/trial/52626 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic, Randomization description: Participants will be randomly assigned to three groups of finger feeding, cup feeding, and syringe feeding blocks with blockes size 6 and 9 ratio of 1: 1. The allocation sequence will be determined using Random Allocation Software (RAS). To allocation cocealment, the type of intervention will be written on paper and placed in sealed opaque envelopes that are numbered sequentially. The envelopes will be opened by the person not involved in the sampling. N/A Premature neonate. Intervention 1: Intervention group 1: 33 premature infants will be breastfed or complementary milk with a 50 ml disposable plastic cup.The baby is kept in a sitting or semi-sitting position with head-body coordination.The edge of the cup is placed on the lower lip of the baby and the baby sucks the milk from the cup with forward movements of the tongue. Intervention 2: Intervention group 2: 33 premature infants will be fed with breast milk or complementary milk through a gavage tube attached to the mother's finger.In this method, breast milk or auxiliary milk is poured into a syringe and a gastric tube is attached to it. After washing the hands and wearing disposable gloves, the researcher or mother will glue the stomach tube to her little finger. By placing a finger in the baby's mouth and sucking, the milk will be transferred to the baby's mouth through the stomach tube. Intervention 3: Intervention group 3: 33 premature infants will be fed breast milk or complementary milk through a syringe.In this feeding method, the piston is squeezed while the premature baby is sucking and the milk is directed to the inside of the cheek. Yes - There is a plan to make this available What will be shared: Only part of the data such as information about the main outcome or the like can be shared. The results of the clinical study will be published as an article. When: Access period starts 6 months after the results are published To whom: All researchers Conditions: Scientific use with reference to the article Where to obtain: sevil hakimi - hakimis@tbzmed.ac.ir How to obtain: The applicant notifies the applicant by email, after receiving the email the results are sent. Comments:
public Parinaz Alinazhad Shebilouy Sofla
South Shariati St., School of Nursing and Midwifery, Tabriz University Of Medical Sciences
Tabriz Iran (Islamic Republic of) 5138947977 +98 912 603 5672 Pr.alinezhad@gmail.com Tabriz University of Medical Sciences scientific Sevil Hakimi
South Shariati St., School of Nursing and Midwifery, Tabriz University of Medical Sciences
Tabriz Iran (Islamic Republic of) 5138947977 0414796770 hakimis@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) The age of the infant at the time of sampling is 30-34 weeks with stable clinical condition Ability to swallow of newborn for two days Apgar minute 5 higher than 7 210 days 238 days Both Intra Ventricular Hemorrhage grade 3 or 4 Sepsis Newborn under CPAP or ventilator Congenital malformation Down Syndrome Neuromuscular diseases P07.33 premature neonate, gestational age 30 completed weeks Other Other Other Intervention group 1: 33 premature infants will be breastfed or complementary milk with a 50 ml disposable plastic cup.The baby is kept in a sitting or semi-sitting position with head-body coordination.The edge of the cup is placed on the lower lip of the baby and the baby sucks the milk from the cup with forward movements of the tongue. Intervention group 2: 33 premature infants will be fed with breast milk or complementary milk through a gavage tube attached to the mother's finger.In this method, breast milk or auxiliary milk is poured into a syringe and a gastric tube is attached to it. After washing the hands and wearing disposable gloves, the researcher or mother will glue the stomach tube to her little finger. By placing a finger in the baby's mouth and sucking, the milk will be transferred to the baby's mouth through the stomach tube. Intervention group 3: 33 premature infants will be fed breast milk or complementary milk through a syringe.In this feeding method, the piston is squeezed while the premature baby is sucking and the milk is directed to the inside of the cheek. Time to reach complete oral nutrition. Timepoint: Before the intervention and then after the intervention. Method of measurement: Using a researcher-made questionnaire. The rate of weight change. Timepoint: The baby's weight will be measured at the beginning of the study and then daily at a specific time in the morning shift before feeding and then after feeding the baby daily until full oral feeding. Method of measurement: Weight in grams with a digital scale. Vice Chancellor for Research and Technology University of Medical Sciences Approved 2020-11-25 Ethics committee of Tabriz University of Medical Sciences Third Floor, Central Building of Number 2, Golgasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)