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IRCT201302058315N5 IRCT 2013-05-13 Vice chancellor for research, Tabriz University of Medical Sciences The effect of clustered care on physiological and behavioral responses in preterm infants The effect of clustered care on physiological and behavioral responses in preterm infants: Randomised cross-over clinical trial 2013-05-15 anticipated Complete https://irct.ir/trial/8763 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Supportive. 2 Other preterm infants. Intervention 1: Clustered care including four invasive procedures (stressor score ten) consists of measuring axillary temperature (2 points), change location of pulse oximeter probe (2 points), gavage (3 points) and changing position (3 points). Intervention 2: Clustered care including three invasive procedures (stressor score seven) consists of measuring axillary temperature (2 points), change location of pulse oximeter probe (2 points) and changing position (3 points). Intervention 3: Clustered care including five invasive procedures (stressor score thirteen) consists of measuring axillary temperature (2 points), change location of pulse oximeter probe (2 points), weighing (3 points), gavage (3 points) and changing position (3 points).
public Marziyeh Avazeh
Shariati South Street, Tabriz
Tabriz Iran (Islamic Republic of) 00984262232793, 00989141284596 m.avazeh@yahoo.com Tabriz School of Nursing and Midwifery scientific Dr Leila Valizadeh
Shariati South Street, Tabriz
Tabriz Iran (Islamic Republic of) +98 41 1479 6770 Valizadehl@tbzmed.ac.ir Tabriz School of Nursing and Midwifery Iran (Islamic Republic of) Inclusion criteria: Being admitted to the NICU; infants' age between 30-32 weeks at birth and 32 weeks during the study; having a minimum weight of 1000 g at the time of study; consent form is signed by parents; absence of congenital anomalies; written order of a physician for gavage; without prohibited changing position; respiratory score lower than or equal to five; no status of asphyxia Exclusion criteria: Infants with IVH grade 3 and 4; periventricular leukomalacia; need for mechanical ventilation; steady decline in HR and O2 sat and respiratory rate of normal range; septicemia or be transferred to the neonatal unit refrain from further testing. 30 years 32 years Both P07.3 28 completed weeks or more but less than 37 completed weeks (196 completed days but less than 259 completed days) of gestation. Other Other Other Clustered care including four invasive procedures (stressor score ten) consists of measuring axillary temperature (2 points), change location of pulse oximeter probe (2 points), gavage (3 points) and changing position (3 points) Clustered care including three invasive procedures (stressor score seven) consists of measuring axillary temperature (2 points), change location of pulse oximeter probe (2 points) and changing position (3 points) Clustered care including five invasive procedures (stressor score thirteen) consists of measuring axillary temperature (2 points), change location of pulse oximeter probe (2 points), weighing (3 points), gavage (3 points) and changing position (3 points) Behavioral responses. Timepoint: Two minutes before the start of clustered care, during the clustered care and by two minutes after it. Method of measurement: The camera is already installed. Physiological responses. Timepoint: Two minutes before the start of clustered care, during clustered care and by two minutes after it. Method of measurement: The camera is already installed. Vice chancellor for research, Tabriz University of Medical Sciences Approved 2013-05-06 Tabriz University of Medical Sciences Ethics Committee Golgasht Street, Tabriz Tabriz Iran (Islamic Republic of)