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IRCT20210607051507N1 IRCT 2021-07-01 Tehran University of Medical Sciences Nasal intermittent positive pressure ventilation with nasal cannula vs. Nasal continuous positive airway pressure as respiratory support in the management of Transient Tachypnea of Newborn Nasal intermittent positive pressure ventilation with nasal cannula vs. Nasal continuous positive airway pressure as respiratory support in the management of Transient Tachypnea of Newborn: A Randomized Control Trial 2021-06-22 anticipated 40 Complete https://irct.ir/trial/56751 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study is a parallel randomized clinical trial that will be performed on neonates of Shariati Hospital of Tehran University of Medical Sciences. Our sample size is 40 people, 20 people will be in each group. In this method, a number of cards are considered as the first group and the same number of cards for the next group. Then, by merging the cards together, a card is taken out and its allocation is recorded. And that card will be returned to the other cards after leaving. The cards are then merged again and another card comes out. This process continues until a random sequence according to the sample size is reached, Blinding description: Concealment process: The list of random allocation of patients will be available only to the epidemiologist of the project. To hide the random allocation process, the order of interventions will be written on 40 cards and each card will be placed in an envelope (with a suitable thickness that it is not possible to read the type of intervention on the cover of the envelope).When the interviewer declares a baby eligible, the methodologist will provide the group with a plan for the type of intervention. The person evaluating the intended outcomes is a third party who is unaware of the random allocation process and the type of treatment performed.For data analysis, a statistician who is separate from the study process and is unaware of all the processes performed will be used. N/A Transient Tachypnea of Newborn. Intervention 1: Intervention group:NIPPV may be applied by a facial mask or nasal cannula. In this study, we used a nasal cannula to deliver positive-pressure breathing by Drager (Babylog 8000 SC) ventilator with flow constant (flow =8). Intervention 2: O2 therapy with CPAP. with pronge and 8-10 flow. 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 more information
public Setareh Sagheb
Shariati Hospital
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8490 1000 dr.ssagheb@yahoo.com Tehran University of Medical Sciences scientific ameneh lamsehchi
Shariati Hospital
Tehran Iran (Islamic Republic of) 1411713135. +98 21 8490 1000 lamsehchila@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) N eonates with TTN were identified with the criteria of Rawlings and Smith including 1.beginning of tachypnea within 6 h after birth; 2. tenacity of tachypnea for at least 12 h; 3.chest radiograph compatible with TTN 4. exclusion of other known respiratory disorders and non-respiratory disorders likely to cause the same features. Clinical features are consist of tachypnea (respiratory rate more than 60) with or without cyanosis, signs of distress (nasal flaring, grunting, and retraction). Radiographic signs may include at least one of these; lung hyper inflation, perihilar congestion or streaking, fluid filled interlobar fissure, bilateral infiltration, pulmonary edema. All of the neonates were born 37 weeks and older. no limit no limit Both neonate delivered less than 37 weeks, significant chromosomal abnormalities, meconium aspiration signs, asphyxia, a newborn baby with a metabolic disorder, congenital heart disease (diagnosed with echocardiography), persistent pulmonary hypertension of neonate, RDS, Pneumonia, and requirement of more than 40 percent FiO2. We excluded neonates who had positive CRP or positive Blood culture or if chest x rays matched with the diagnosis of pneumonia. Intermittent Positive Pressure Ventilation , Nasal Continuous Positive Airway Pressure, Transient Tachypnea of Newborn Treatment - Devices Treatment - Devices Intervention group:NIPPV may be applied by a facial mask or nasal cannula. In this study, we used a nasal cannula to deliver positive-pressure breathing by Drager (Babylog 8000 SC) ventilator with flow constant (flow =8). O2 therapy with CPAP. with pronge and 8-10 flow Oxygen consumption. Timepoint: 24 hours of birth. Method of measurement: CPAP .NIPPV. The duration of respiratory support. Timepoint: during hospitalization. Method of measurement: due to records patients file. Tehran university of medical sciences Approved 2020-04-30 Tehran University of medical sciences Enghelab street. Ghods Ave. tehran Tehran Iran (Islamic Republic of)