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IRCT20150424021917N10 IRCT 2020-04-22 Tabriz University of Medical Sciences The effect of kangaroo care by mother and surrogate on nutritional behavior of preterm neonates : A randomised controlled clinical trial The effect of kangaroo care by mother and surrogate on nutritional behavior of preterm neonates : A randomised controlled clinical trial 2020-05-04 anticipated 80 Complete https://irct.ir/trial/45904 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Samples will be randomly divided and stratified based on neonate`s age (31-32,6 and 33-35 weeks old) with 4 and 6 blocks with 1:1 ratio in two groups: intervention and control groups. Allocation sequences will be determined using RAS. Allocation concealment will be done using opaque-sealed envelopes numbered in sequence and opened by someone other than the researcher. N/A Preterm neonates. Intervention 1: Intervention group: Mother/surrogate kangroo care, 3 times of daily care once by mother and twice by surrogate in the last two time of care up to 5 days each time 60 minutes. Intervention 2: Control group: 3 times of daily care by mother up to 5 days each time 60 minute. Yes - There is a plan to make this available What will be shared: Only part of the information, such as information on the main outcome or the like, can be shared. The results of clinical study will be published as article. When: Start publishing period 6 months after printing results. Immediately after publishing the results. To whom: All researchers Conditions: Scientific using with citation to article Where to obtain: Sevil Hakimi hakimis@tbzmed.ac.ir How to obtain: The applicant sends an application via e-mail. After receiving the email, the results will be sent. Comments:
public Mahboubeh Jamehdar
South Shariati Street, Nursing & Midwifery Faculty, Tabriz University of Medical Sciences
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3479 6770 mahboubeh.jamehdar@yahoo.com Tabriz University of Medical Sciences scientific Sevil Hakimi
South Shariati Street, Nursing & Midwifery Faculty, Tabriz University of Medical Sciences
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3479 6770 hakimis@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Gravida 1,2 31-35 weeks neonates Neonate weight more than 1500 g unfixed female surrogate 217 days 245 days Both Neonatal sepsis Neonate connection to ventilator CPAP use Catheter in umbilical vein Prescribing any medication to the neonate that may affect it's sleep Neonate intra ventricular hemorrhage Cleft lips and cleft palate Mother's epilepsy or surrogate Mother’s or surrogate’s addiction to any drug New scare in part of mother’s/surrogate’s body that is in direct contact with baby's Skin rash Use of perfume and perfume soap P07.33 Preterm newborn, gestational age 30 completed weeks Behavior Behavior Intervention group: Mother/surrogate kangroo care, 3 times of daily care once by mother and twice by surrogate in the last two time of care up to 5 days each time 60 minutes Control group: 3 times of daily care by mother up to 5 days each time 60 minute Nutritional behavior of preterm neonate. Timepoint: Once before the intervention and once again after the intervention for up to 5 days. Method of measurement: Using the questionnaire Preterm Infant Breastfeeding Behavior Score (PIBBS). Nutritional effect. Timepoint: once before the intervention and once again after the intervention for up to 5 days. Method of measurement: With using of standard questionnare. Physiological function of preterm neonate (heart rate, temperature, respiratory rate and arterial oxygen saturation). Timepoint: once before the intervention and once again after the intervention for up to 5 days. Method of measurement: temperature will be measured with a thermometer; heart-rate and arterial oxygen saturation will be checked with Pulse-oximeter; respiratory rate will be tested by chest touch and observation. Tabriz University of Medical Sciences Approved 2020-02-03 Ethics committee of Tabriz University of Medical Sciences Research department, Third floor, Central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz, East Azerbaijan Tabriz East Azarbaijan Iran (Islamic Republic of)