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IRCT20201130049544N1 IRCT 2021-06-19 Tehran University of Medical Sciences Investigating the effects of Kangaroo care on Delirium in Neonates under Non-Invasive mechanical Ventilation Investigating the effects of Kangaroo care on Delirium in Neonates under Non-Invasive mechanical Ventilation 2021-06-22 anticipated 50 Complete https://irct.ir/trial/54863 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: In this study, the samples are randomly assigned to two groups of intervention and control. The intervention group will receive kangaroo care intervention (for at least 30 minutes a day) based on the study protocol and will eventually be compared to the control group that received routine care, Randomization description: After entering the study, the samples are assigned to the intervention and control groups based on the start date of non-invasive mechanical ventilation. In this case, if the sample is included in the study on the odd date , it is placed in the intervention group, and if it is included in the study on the even date, it is placed in the control group. If several samples meet the entry requirements on a date, they will be entered into each intervention or control group based on a lottery. N/A delirium. Intervention 1: Intervention group: This study is performed on neonates who have reached at least 35 weeks of gestation when non-invasive mechanical ventilation begins. If the baby is born full-time, the maximum time he/she can enter the study is up to 28 days after birth (end of the neonatal period), and if the baby is born pre-term, his/her corrected age is (41 weeks after fertilization) is considered as the maximum time allowed to enter the study. Intervention in the present study, kangaroo care will be in the form of skin-to-skin contact between mother and baby. The minimum duration of skin-to-skin contact is 30 minutes (24 hours a day), which can be intermittent or continuous. The study outcome will then be compared with the control group, who received routine care. Intervention 2: Control group: The control group in this study will receive routine care. 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 Because this study is a thesis project, a decision will be made in consultation with the research team regarding the publication of the case.
public Nasim Mirzaei Salout
Unit. 5, No 52, Toos St, Ghasredasht St, Azarbaijan Ave, Jomhouri Squ
Tehran Iran (Islamic Republic of) 1345967880 +98 21 6617 9674 nasim_mirzaei14@yahoo.com Tehran University of Medical Sciences scientific Nasim Mirzaei Salout
Unit. 5, No 52, Toos St, Ghasredasht St, Azarbaijan Ave, Jomhouri Squ
Tehran Iran (Islamic Republic of) 1345967880 +98 21 6617 9674 nasim_mirzaei14@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Being under non-invasive mechanical ventilation The corrected age of the neonate at the time of enrollment (initiation of non-invasive mechanical ventilation) should be 35 weeks gestational age (after fertilization) Not being treated with sedatives and anticonvulsants no limit 28 days Both convulsion and followed that taking anticonvulsants as well as starting sedatives Exposure to non-invasive mechanical ventilation for less than 72 hours Dissatisfaction and unwillingness of the neonate guardian to enter the study Initiation of invasive mechanical ventilation F06.8 Other specified mental disorders due to known physiological condition Behavior Other Intervention group: This study is performed on neonates who have reached at least 35 weeks of gestation when non-invasive mechanical ventilation begins. If the baby is born full-time, the maximum time he/she can enter the study is up to 28 days after birth (end of the neonatal period), and if the baby is born pre-term, his/her corrected age is (41 weeks after fertilization) is considered as the maximum time allowed to enter the study. Intervention in the present study, kangaroo care will be in the form of skin-to-skin contact between mother and baby. The minimum duration of skin-to-skin contact is 30 minutes (24 hours a day), which can be intermittent or continuous. The study outcome will then be compared with the control group, who received routine care. Control group: The control group in this study will receive routine care. Score of Cornell Assessment of Pediatric Delirium (CAPD) questionnaire. Timepoint: Evaluation of both intervention and control groups for delirium during the study period is performed using the Cornell Assessment of Pediatric Delirium (CAPD) at 7 p.m. daily by researcher or caregiver based on documentation and observations. Method of measurement: Cornell Assessment of Pediatric Delirium (CAPD) questionnaire. Tehran University of Medical Sciences Approved 2021-01-18 Ethics Committee in Research, School of Nursing, Midwifery and Rehabilitation, Tehran University of Unit. 5, No 52, Toos St, Ghasredasht St, Azarbaijan Ave, Jomhouri Squ Tehran Tehran Iran (Islamic Republic of)