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IRCT20230807059068N1 IRCT 2023-09-14 Esfahan University of Medical Sciences Comapring the effectiveness of establishing continuous positive airway pressure through RAM cannula with nasal mask and nasal prong in newborns Comparing the effectiveness of establishing continuous positive airway pressure through RAM cannula with nasal mask and nasal prong in newborns admitted to neonatal intensive care unit 2023-09-23 anticipated 90 Complete https://irct.ir/trial/71916 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 90 infants participating in the study will be subjected to continuous positive airway pressure treatment with RAM cannula (30 people), nasal mask (30 people) and nasal prongs (30 people) in three groups using block randomization method. Six are used. All blocks are the same size. Within each block of 6, two people are randomly assigned to group A, two people to group B, and two people to group C. 15 blocks of 6 are used for this study. The software used for block allocation is R software. Blockrand Package is used in this software. Randomization of six permutation blocks, all possible blocks are arranged as follows Block 1: ABCABC, Block 2: AABBCC, Block 3: ABCCBA, Block 4: CCBBAA, Block 5: CBACBA, Block 6: CBAABC To select 90 people, we randomly select 15 blocks from numbers 1 to 6. Using R software, we choose a random number between 1 and 6. For example, if number 6 is selected as the sixth block and number 2 is selected as the second block, the people entering the study will be given CBAABCAABBCC respectively. Finally, group A received the intervention of short nose cannula, group B received the nasal mask intervention, and group C received the RAM cannula intervention through connection to the system. After study completion, intervention data for each group can be added to the data frame for analysis. Each intervention is written on a card and the cards are sealed in envelopes, then when a new person enters the study, the next envelope is opened and the sample is assigned to the corresponding treatment. N/A Comparing the effectiveness of establishing continuous positive airway pressure through RAM cannula with nasal mask and nasal prong in newborns admitted to neonatal intensive care unit. Intervention 1: Intervention group:Babies treated with RAM cannula: Babies in this group are supported by a Neotech RAM cannula of the right size according to the manufacturer's instructions, which is properly fixed on the baby's face and is directly connected to the continuous positive airway pressure circuit. Intervention 2: Control group1: Control group: group supported by nasal prongs: infants in this group are supported by Medin nasal prongs with the appropriate size (according to the manufacturer's recommendations) whose prongs are directly attached using Mini flow and rubber bands that are placed on Medin caps with the appropriate size ( according to the manufacturer's recommendations) are connected to the continuous positive pressure circuit of the airways. Intervention 3: Control group2: Nasal mask supported group (second control group): Babies in this group are supported by Medin model nasal mask with the right size, which is connected to the positive pressure circuit using Mini flow and rubber bands on caps with Medin model with the right size (according to the manufacturer's recommendations). Continuous airways are connected and placed. 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 There is no further information
public Zeinab Keshavarzian kelishadi
No 1. Andisheh A1 CPLX, Shafagh Blvd. Esfahan, Iran
Isfahan Iran (Islamic Republic of) 8456119488 +98 31 3782 0696 z.keshavarzian1992@gmail.com Esfahan University of Medical Sciences scientific Zeinab Keshavarzian Kelishadi
No 1. Andisheh A1 CPLX, Shafagh Blvd. Esfahan, Iran
Isfahan Iran (Islamic Republic of) 8456119488 +98 31 3782 0696 z.keshavarzian1992@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Babies born with a gestational age of 28-34 weeks Need to connect to continuous positive airway pressure within the first hour of birth Apgar more than 6 in the fifth minute Absence of congenital malformation including nasal obstruction or severe upper airway malformation such as Cowan's atresia, cleft lip and palate, congenital diaphragmatic hernia, cardiac anomalies, tracheoesophageal fistula, Pierre-Robin sequence Absence of wounds or lesions in the nose and upper lip of the baby Consent of parents of infants to participate in the study Having at least a bachelor's degree in nursing At least one year of clinical experience in neonatal intensive care unit 196 days 238 days Both Death of a baby Changing the type of respiratory interface The baby needs endotracheal intubation The baby needs resuscitation Parents' unwillingness to continue the treatment process Referral of the baby to another hospital during the study Unwillingness of nurses to continue cooperation Failure to answer questionnaire questions Changing the place of clinical activity to another department during the study Treatment - Devices Treatment - Devices Treatment - Devices Intervention group:Babies treated with RAM cannula: Babies in this group are supported by a Neotech RAM cannula of the right size according to the manufacturer's instructions, which is properly fixed on the baby's face and is directly connected to the continuous positive airway pressure circuit. Control group1: Control group: group supported by nasal prongs: infants in this group are supported by Medin nasal prongs with the appropriate size (according to the manufacturer's recommendations) whose prongs are directly attached using Mini flow and rubber bands that are placed on Medin caps with the appropriate size ( according to the manufacturer's recommendations) are connected to the continuous positive pressure circuit of the airways. Control group2: Nasal mask supported group (second control group): Babies in this group are supported by Medin model nasal mask with the right size, which is connected to the positive pressure circuit using Mini flow and rubber bands on caps with Medin model with the right size (according to the manufacturer's recommendations). Continuous airways are connected and placed Mean success and failure of continuous positive airway pressure. Timepoint: From the start of the intervention for 72 hours. Method of measurement: A researcher-made checklist for the effectiveness of continuous positive airway pressure. Frequency distribution of nose injuries. Timepoint: During the study. Method of measurement: Nose injury checklist. Average satisfaction score of nurses. Timepoint: Immediately after the intervention. Method of measurement: A researcher-made questionnaire of nurses' views on the ease of doing work with three types of respiratory interfaces. Esfahan University of Medical Sciences Approved 2023-09-03 Isfahan University of Medical Sciences Esfahan University of Medical Sciences, Hezar Jarib St., Isfahan, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)