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IRCT20190826044623N1 IRCT 2019-10-17 Mashhad University of Medical Sciences The effect of head positioning on the tissue oxygenation of brain The effect of head positioning on the tissue oxygenation of brain in preterm infants 2019-09-06 anticipated 30 Complete https://irct.ir/trial/41763 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Prevention, Randomization description: All possible sequence combinations are coded for 6 study positions in SPSS software, 720 modes. We assign a unique number to each position. In the study sample number, random numbers are generated by SPSS software. Hence the random modes of the research units are obtained.Write each of the modes in a separate card and put all the cards in a package. For each research unit, we remove and use one of the cards from the envelope, Blinding description: The analyst will be unaware of the intervention and control groups. N/A The effect of head positioning on the tissue oxygenation of brain in preterm infants. Intervention group: In the intervention group, infants are placed in supine position and every 2 hours the head is switched to one of 6 modes [1 midline head and 0° bed head .2 The head rotates 60-45 ° from the midline to the left and the bed head 0°. 3 The head rotates 60-45 ° from the midline to the right and the bed head 0°.4 midline head position with the bed head 15- 30°, 5 The head rotates 60-45 ° from the midline to the left and the bed head 15- 30°. 6 The head rotates 60-45 ° from the midline to the right and the bed head 15- 30° ].During each head positioning, tissue oxygenation of brain is recorded by the NIRS device. The infants under intervention are also used as their control group. And according to the routine inpatient treatment center, they receive their medical care before the intervention, and brain tissue oxygenation data are collected and compared with post-intervention data.And they are also used as witnesses for this purpose.. Yes - There is a plan to make this available What will be shared: All potential data can be shared after unidentifiable people. When: The access period starts 2 months after the results are published. To whom: The data are made available to researchers working in academic and scientific institutions, and to those involved in the industry as well as to the Ministry. Conditions: If positive, this study could lead to a caring approach for the premature infant within the first 72 hours after birth, which improves brain oxygenation and hemodynamics and reduces the chance of occurrence and severity of intraventricular hemorrhage in the premature infant. Where to obtain: Zeinab Rabbani Mohammadie:rabbanimz961@mumc.ac.ir,Phone Call:00989910435332 Dr Monir Ramezani:ramezanimn@mums.ac.ir,Phone Call:00989124186326 How to obtain: The applicant should contact through the given contact number and e-mail. Comments:
public Zeinab Rabbani Mohammadie
Unit 1, Floor 1, No. 154, Villaye 7
Mashhad Iran (Islamic Republic of) 9171618995 +98 51 3868 9372 Rabbanimz961@mums.ac.ir Mashhad University of Medical Sciences scientific Zeinab Rabbani Mohammadie
Unit 1, Floor 1, No. 154, Villaye 7
Mashhad Iran (Islamic Republic of) 9171618995 +98 51 3868 9372 Rabbanimz961@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) The age of the infant on a Ballard basis is less than or equal to 32 weeks at the time of study. infant weight under 1500 grams. neonate stable condition (non Invasive mechanical ventilation and hemodynamic status stable neonate)Have. Apgar score of first minute exceeds 5 and fifth minute greater than 7. A hemoglobin level greater than or equal to 12 g / dl. Mean arterial blood pressure (MAP) is within normal range. no limit 8 months Both The infant will have have congenital and chromosomal abnormalities. The infant have intrauterine growth restriction (IUGR) . The infant receiving the red blood cell product is dense. The infant with known intracranial hemorrhage. P52.3 Unspecified intraventricular (nontraumatic) hemorrhage of newborn Prevention Intervention group: In the intervention group, infants are placed in supine position and every 2 hours the head is switched to one of 6 modes [1 midline head and 0° bed head .2 The head rotates 60-45 ° from the midline to the left and the bed head 0°. 3 The head rotates 60-45 ° from the midline to the right and the bed head 0°.4 midline head position with the bed head 15- 30°, 5 The head rotates 60-45 ° from the midline to the left and the bed head 15- 30°. 6 The head rotates 60-45 ° from the midline to the right and the bed head 15- 30° ].During each head positioning, tissue oxygenation of brain is recorded by the NIRS device. The infants under intervention are also used as their control group. And according to the routine inpatient treatment center, they receive their medical care before the intervention, and brain tissue oxygenation data are collected and compared with post-intervention data.And they are also used as witnesses for this purpose. Tissue oxygenation of brain. Timepoint: After every two hours of head positioning, tissue oxygenation of brain is recorded by the NIRS device.It should be noted that before the intervention, the tissue oxygenation of brain of each infant is measured and recorded within ten minutes to obtain the baseline value for each infant and compare with subsequent values. Method of measurement: NIRS device. Mashhad University of Medical Sciences Approved 2019-07-21 Ethics committee of School of Nursing and Midwifery - Mashhad University of Medical Sciences Unit 1, Floor 1,No. 154, Vilaye 7 Mashhad Razavi Khorasan Iran (Islamic Republic of)