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IRCT20140604017972N14 IRCT 2021-05-18 payam noor university The effect of parent participation care on premature infants neurobehavioral development PPC Study Parent Participation Care in neurobehavioral development of preterm infants in the neonatal intensive care unit 2021-06-20 anticipated 186 Complete https://irct.ir/trial/55885 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The allocation is made for each newborn as a randomization unit and by a randomized balanced block method (without stratification) is done with a predetermined block size. Using excel software, which assigns each baby to two groups, with sequential numbers and attached to their forms in opaque sealed envelopes. This is done by one of our colleagues who is not involved in the study and hided the randomization list until the statistical analysis, Blinding description: - The parents and their infants are directly involved as executor and the control group don’t receive any intervention, can't be blinded them. - Regarding the researcher who is as the executor of the study in the field, and teach parents how to perform the intervention and follow the consequences and examinations, can't be blinded any of them. - The only person who kept concealed is the data analyzer, he will analyzed groups named A and B. N/A 1. Born at preterm 2. Low birth weight. Intervention 1: 186 hospitalized premature infants’ ≤32 weeks of gestation are included in the study on days 3 to 7 after birth without congenital anomalies or serious problems and lack of chance of death. After announcing the informed consent of the parents and the random assignment of the infants in the "intervention group" and the "control group"; Examinations and clinical evaluation to determine fetal age will performed with Dubowitz instrument in "both groups" after physician approval for "intervention group", parents will be given sufficient training on how to hug and hug skin to skin (kangaroo care). The presence of parents in the nicu with no time limit for any type of cuddling (hugging or kangaroo care) and its effectiveness on behavioral neurodevelopment at 34 and 40 weeks of age equivalent to the postnatal semester age is assessed by TIMP. The control group receiving "routine care" is compared. Intervention 2: Control group: take nicu routine care. Yes - There is a plan to make this available What will be shared: 1- study tools and statistical data from the whole data When: 6 months after end of study To whom: Neonatologists, Neonatal Intensive Care Nurses, Neonatal Occupational Therapists Conditions: The family-centered Interventions in the intensive care units favored the overall neurobehavioral performance in VLBW preterm infants at term age. Where to obtain: Zahra Godarzi godarziz@tums.ac.ir Tell: 00989122072918 How to obtain: By Email is the best way to have contact in short time Comments:
public Zahra Godarzi
No. 26, Soleimani Ave., hedayati (kerman shomali) noamoz street.
Tehran Germany 1675784514 +98 21 2250 7961 godarziz@tums.ac.ir payam noor university scientific Dr Parissa Mohagg
Satarkhan Av, Niayesh St, Hazrate Rasoole Akram Hospital,
Tehran Germany 1449614535 009822507961 pmohagh@yahoo.com Iran University of Medical Sciences Germany Germany - Parents signed informed consent. - Singleton born premature infants ≤ 32 weeks - weighing less than <1500g gestational age - enrolled the first born in 3-7 days of life. - Mothers should not take any psychiatric medication and any drug abuse - fathers should not take any psychiatric medication and any drug abuse - Parents live together. 180 days 280 days Both - without any: - congenital physical and cerebral seizure - Intraventricular and Intracerebral hemorrhage - Persistent instability of physiological conditions (pulse respiration and oxygen saturation of blood). - necrotizing enterocolitis. -Those infants expected to expire within the first days of life were excluded. P07 Disorders of newborn related to short gestation and low birth weight, not elsewhere classified Prevention N/A 186 hospitalized premature infants’ ≤32 weeks of gestation are included in the study on days 3 to 7 after birth without congenital anomalies or serious problems and lack of chance of death. After announcing the informed consent of the parents and the random assignment of the infants in the "intervention group" and the "control group"; Examinations and clinical evaluation to determine fetal age will performed with Dubowitz instrument in "both groups" after physician approval for "intervention group", parents will be given sufficient training on how to hug and hug skin to skin (kangaroo care). The presence of parents in the nicu with no time limit for any type of cuddling (hugging or kangaroo care) and its effectiveness on behavioral neurodevelopment at 34 and 40 weeks of age equivalent to the postnatal semester age is assessed by TIMP. The control group receiving "routine care" is compared. Control group: take nicu routine care 1. Heart rate. Timepoint: 1. Before, during and after intervention. Method of measurement: 1. pulse oximeter monitoring device. 2. Respiration rate. Timepoint: 2. Before, during and after intervention. Method of measurement: 2. pulse oximeter monitoring device. 3. oxygen saturation level. Timepoint: 3. Before, during and after intervention. Method of measurement: 3. pulse oximeter monitoring device. 4. Behavioral responses. Timepoint: 4. Before, during and after intervention. Method of measurement: 4. The Neonatal Behavioral Assessment Scale. 5. Indicators of neuromotoral function. Timepoint: 5. at 35 and 40 weeks of age. Method of measurement: 5. The Test of Infant Motor Performance (TIMP). 1. Neurobehavioral development. Timepoint: 1. At the age of ≤32 weeks 2. At the age of 35 weeks 3. At the age of 40 weeks. Method of measurement: 1. Dubowitz Scale: To assessment neurological, physical criteria and to determine gestational age at birth. 2. TIMP: Is a motor outcome to assess the posture and selective control of movement needed by infants for functional performance in daily life. 3. TIMP: Is a motor outcome to assess the posture and selective control of movement needed by infants for functional performance in daily life. payam noor university Approved 2021-01-26 https://ethics.research.payamnoor.ac.ir No. 26, Soleimani Ave., Hedayati (kerman shomali) Noamoz Street.. Tehran Tehran Germany