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IRCT201601264613N16 IRCT 2016-03-03 Vice chancellor for Research of Tabriz University of Medical Sciences Effects of non-nutritive sucking on survival gastric residual volume in preterm newborn Effects of non-nutritive sucking on survival gastric residual volume in preterm newborn: A randomized controlled clinical trial 2016-02-29 anticipated 86 Complete https://irct.ir/trial/4937 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive. N/A prematurity. Intervention 1: Intervention group 1: Infants who are in this group,non-nutritive sucking with pacifier will begin since the beginning of gavages (during gavages) and will continue for 10 minutes after its (the method of gavages will be pushed in all neonates). This practice, three times a day (in the afternoon in hours 3, 5 and 7) will continue for 7 days. Intervention 2: Control group : Infants who are in this group will be gavages on routine ward’s program but they will not be received non-nutritive sucking.
public Tahereh Rafiezadeh
School of Nursing and Midwifery , Shariati South Street , Tabriz , Iran
Tabriz Iran (Islamic Republic of) 51668-44199 +98 41 3441 8387 t.rafizadeh@gmail.com Tabriz University of Medical Sciences scientific Dr Sousan Valizadeh
Nursing and Midwifery Faculty, Shariati South Street , Tabriz , Iran Tabriz East Azerbaijan Iran, Islamic Republic Of 51668-44199 00984114790365 00989143098650 00984114796969 valizades@tbzmed.ac.irvalizadehsousan13@gmail.com http://researchvice.tbzmed.ac.ir
Tabriz Iran (Islamic Republic of) 51668-44199 +98 41 3479 0364 valizades@tbzmed.ac.ir valizadehsousan13@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion criteria: Infants' age between 28-32 weeks; weight between 750-1500 gm; clinically stable infants Physiological indicators including heart rate , respiratory rate and O2 sat ) No medical contraindications for non-nutritive sucking, No congenital abnormalities and digestive system problems by verifying the doctor ordered for gavage feeding, breastfeeding, not the Ventilator Exclusion criteria :If, after entering the study , problems such as : Intraventricular hemorrhage grade 3 and 4 , Periventricular locomalacy , necrotizing enterocolitis , BPD , chronic diseases of the lung, mechanical ventilation , neonatal seizure , positive culture , meningitis , NPO baby for any reason, more than 24 hours the baby will excluded from the study. no limit 1 month Both Z76.2 Health supervision and care of other healthy infant and child N/A Treatment - Other Intervention group 1: Infants who are in this group,non-nutritive sucking with pacifier will begin since the beginning of gavages (during gavages) and will continue for 10 minutes after its (the method of gavages will be pushed in all neonates). This practice, three times a day (in the afternoon in hours 3, 5 and 7) will continue for 7 days. Control group : Infants who are in this group will be gavages on routine ward’s program but they will not be received non-nutritive sucking. Gastric residual volume. Timepoint: One and two hours after gavage. Method of measurement: Using a syringe. Vice chancellor for Research of Tabriz University of Medical Sciences Approved 2016-01-18 Ethics Committee of Tabriz University of Medical Sciences Deputy of Research, Tabriz University of Medical Sciences ,Golgasht street , Tabriz Tabriz East Azerbaijan Iran, Islamic Republic Of 5138947-977 Tabriz Iran (Islamic Republic of)